Morphologic Characterization of Carotid Artery Plaque Using Virtual Angioscopy
Magnetization Transfer Quantitation and Characterization for Clinical Scanners
Treatment of Acute Deep Vein Thrombosis of the Lower Extremity with Intraclot, Pulse-sprayed Recombinant Tissue Plasminogen Activator, Plus Heparin and Warfarin: A Pilot Study
Clinical Evaluation and Imaging of the Posterior Tibialis Tendon in Patients and Normal Subjects
Detection of Coronary Artery Calcification: Comparison of Volumetric and Electron Beam Computed Tomography
Sonographic Evaluation of the Effects of Raloxifene on the Uterus and Ovaries in Premenopausal Patients at High Risk for Developing Breast Cancer
Evaluation of Treated and Untreated Stroke
Contrast-enhanced Magnetic Resonance Angiography in the Diagnosis of Atherosclerotic Disease: A Pilot Technical Development Study
Nuclear Magnetic Resonance Scanning on Patients
Diagnostic Efficacy of Virtual Bronchoscopy
Normal Volunteer Scanning on Magnetic Resonance
Examination of the Hemodynamics of the Portal Venous System in Normal Volunteers Using Magnetic Resonance Imaging
Comparison of Contrast-enhanced Magnetic Resonance Angiography and Conventional Angiography in the Diagnosis of Atherosclerotic Disease: A Pilot Study
Use of the "Intraoperative" Quick Parathyroid Hormone Assay During Parathyroid Venous Sampling
INTRAMURAL
RESEARCH PROJECT
Z01 CL-00075-04 DRD
October 1, 1999 to September 30, 2000
Title of Project:
Morphologic Characterization of Carotid Artery Plaque Using Virtual Angioscopy
Principal Investigator:
R.M. Summers, M.D., Ph.D.
DRD, CC, NIH
Bethesda, MD 20892
Other Personnel:
P.L. Choyke, M.D., DRD
N.J. Patronas, M.D., DRD
Collaborating Units:
NINDS (T.J. DeGraba, M.D.)
NCI (D. Kleiner, M.D.)
Department of Surgery, Georgetown Univ. (M. Gomes, M.D.)
National Naval Medical Center (G. Ketron, M.D.)
Staff-Years:
1.0
Human Subjects:
x (a) Human subjects (b) Human tissues (c) Neither
(a1) Minors
x (a2) Interviews
Summary of Work: This project explores the efficacy of a new diagnostic method for evaluating the vasculature known as virtual angioscopy (VA). VA is performed by acquiring high-resolution images of the blood vessels of interest, using either computed tomography or magnetic resonance (MR) images. These images are used to generate a three-dimensional (3D) model of the blood vessel wall on a graphics workstation. The model can be manipulated to allow the viewer to "fly through" the blood vessel, providing views similar to those obtained during angioscopy. The technique produces a display of human arterial and venous anatomy in a readily understood format. Moreover, it may allow investigation of vascular stenosis and atherosclerotic plaques. The research literature suggests that plaque morphology may be an important determinant of the incidence of stroke and transient ischemic attack. Patients studied in this protocol will have known atherosclerotic plaque in the region of the carotid bulb and will have been referred for carotid endarterectomy. The surgery will be done at Georgetown University Hospital or the National Naval Medical Center, and the imaging will be done in the NIH Clinical Center Department of Radiology. The study design consists of high resolution MR scanning of the neck followed by 3D surface rendering of the carotid arteries. Plaque morphology will be compared to pathologic analysis. We anticipate that VA will yield new insights into plaque morphology. Despite collaborations with the National Institute of Neurological Disorders and Stroke (T.J. DeGraba, M.D.) to ensure increased patient accrual, we have had difficulty recruiting patients due to the need for the patients to have MR image scans just before major surgery at another hospital.
This project was terminated in November 1999.
INTRAMURAL
RESEARCH PROJECT
Z01 CL-00076-03 DRD
October 1, 1999 to September 30, 2000
Title of Project:
Magnetization Transfer Quantitation and Characterization for Clinical Scanners
Principal Investigator:
A.P. Dagher, M.D., Ph.D.
DRD, CC, NIH
Bethesda, MD 20892
Other Personnel:
N.J. Patronas, M.D., DRD
P.L. Choyke, M.D., DRD
Collaborating Unit:
NB, NINDS (A. Virta-Paras, M.D.)
Staff-Years:
2.0
Human Subjects:
x (a) Human subjects (b) Human tissues (c) Neither
(a1) Minors (a2) Interviews
Summary of Work: This protocol was used to characterize the chemical exchange process in tissue. We have had success in implementing the Fast Spin Echo pulse sequence with Magnetization Transfer with the help of Dr. Robert Balaban of the National Heart, Lung, and Blood Institute and have been able to show for the first time that we can exhibit chemical exchange at 1.5 Tesla in a urea phantom. Using the same parameters, we have been able to get urea maps of the normal kidney that may actually change with hydration. The potential to exhibit other metabolites in tissue remains. There is potential in the technique to provide information on normal physiology and disease states. We are submitting the results of the kidney analysis to radiology and plan to continue the protocol.
INTRAMURAL
RESEARCH PROJECT
Z01 CL-00077-03 DRD
October 1, 1999 to September 30, 2000
Title of Project:
Treatment of Acute Deep Vein Thrombosis of the Lower Extremity with Intraclot,
Pulse-sprayed Recombinant Tissue Plasminogen Activator, Plus Heparin and Warfarin:
A Pilot Study
Principal Investigator:
R. Chang, M.D.
DRD, CC, NIH
Bethesda, MD 20892
Other Personnel:
B. Wood, M.D., DRD
T.H. Shawker, M.D., DRD
Collaborating Units:
NHLBI (R. Cannon, M.D.; M. Horne, M.D.)
NM, CC (C. Chen, M.D.)
Staff-Years:
2.0
Human Subjects:
x (a) Human subjects (b) Human tissues (c) Neither
(a1) Minors (a2) Interviews
Summary of Work: The objective of the study is to evaluate recombinant tissue plasminogen activator (rtPA) for treatment of acute deep vein thrombosis of the lower extremity. The study is designed to evaluate efficacy, safety, and cost of this form of treatment for restoration of venous function in the lower extremity.
Seven patients have been treated, all with excellent results. Only two patients have had evidence of small pulmonary emboli during treatment, detected on ventilation perfusion lung scans that are obtained in all patients accepted into the protocol. None of these patients were clinically symptomatic. One patient developed a non-life-threatening biceps hematoma probably induced by automatic blood pressure monitoring during the rtPA treatment. No other complications have occurred.
Preliminary results have been submitted for publication in a case report for JAMA, and in an article submitted to the American Journal of Medicine.
INTRAMURAL
RESEARCH PROJECT
Z01 CL-00078-03 DRD
October 1, 1999 to September 30, 2000
Title of Project:
Clinical Evaluation and Imaging of the Posterior Tibialis Tendon in Patients
and Normal Subjects
Principal Investigator:
A. Premkumar, M.D.
DRD, CC, NIH
Bethesda, MD 20892
Other Personnel:
T.H. Shawker, M.D., DRD
Collaborating Units:
DRM (L. Gerber, M.D.; M.B. Perry, M.D.)
NCI (D. Venzon, Ph.D.)
Staff-Years:
2.0
Human Subjects:
x (a) Human subjects (b) Human tissues (c) Neither
(a1) Minors (a2) Interviews
Summary of Work: Posterior tibialis tendon pain and dysfunction is a problem whose early diagnosis and treatment may prevent significant disability and surgery. Pain in the region of the medial maleolus and arch is sometimes difficult to attribute to a specific anatomical structure based on clinical exam, especially early in the course of posterior tibial tendon dysfunction. Therefore, many patients with posterior tibial tendon dysfunction may go undiagnosed. Magnetic resonance imaging (MRI) is the current standard diagnostic imaging technique utilized in the diagnosis of foot and ankle problems. Our study is designed to determine if there is a correlation between the clinical exam, ultrasonography, and MRI, and determine if MRI can be replaced with the less expensive and readily available ultrasound examination.
This study began enrolling volunteers in November 1997. We have studied 15 normal volunteers and 30 individuals with foot pain so far. No complications were encountered. We plan to continue the protocol to enroll 30 patients with foot pain as projected. We were able to visualize the posterior tibialis tendon and the flexor digitorum longus tendons well by both MRI and sonography. Statistical measurements are being made to determine the range of normal measurements of the tendons and to determine whether there is good correlation between findings seen on MRI, sonography, and clinical evaluation. Preliminary findings were presented at the annual meeting of the American Roentgen Ray Society in May. We hope to publish our data soon.
INTRAMURAL
RESEARCH PROJECT
Z01 CL-00079-02 DRD
October 1, 1999 to September 30, 2000
Title of Project:
Detection of Coronary Artery Calcification: Comparison of Volumetric and Electron
Beam-computed Tomography
Principal Investigator:
A. Ling, M.D.
DRD, CC, NIH
Bethesda, MD 20892
Other Personnel:
N.A. Avila, M.D., DRD
Collaborating Unit:
NHLBI (R. Cannon, Ph.D.; A. Quyyumi, M.D.)
Staff-Years:
1.1
Human Subjects:
x (a) Human subjects (b) Human tissues (c) Neither
(a1) Minors (a2) Interviews
Summary of Work: The purpose of this protocol is to evaluate new imaging technology for the early detection of coronary atherosclerosis in comparison to a previously established variation of the same method. The new method has a number of desirable features in comparison with the old, but its practical application would be enhanced if comparability could be established. This comparison is accomplished by simply conducting both new and established procedures in the same patients. No patient complications have occurred, though this should not be surprising given the simplicity of the experimental protocol, and the noninvasiveness of the underlying procedures.
To date, we have collected data on 50 patients, and though this is far short of the number requested of the Institutional Review Board on statistical grounds, there appears to be good correlation between the two techniques. We plan to continue the protocol, and hope to publish the results of the comparison at a suitable time.
INTRAMURAL
RESEARCH PROJECT
Z01 CL-00080-02 DRD
October 1, 1999 to September 30, 2000
Title of Project:
Sonographic Evaluation of the Effects of Raloxifene on the Uterus and Ovaries
in Premenopausal Patients at High Risk for Developing Breast Cancer
Principal Investigator:
A. Premkumar, M.D.
DRD, CC, NIH
Bethesda, MD 20892
Other Personnel:
A. Avila, M.D., DRD
D. Johnson, R.T., DRD
J. Zujewski, M.D., Medical Oncologist
Collaborating Units:
NCI (G. Cusack, RN; M. Noone, B.S.N.; J. Goldstein, M.S., N.P.; D. Venzon, Ph.D.)
Univ. of Tampa, Florida (A. Parsons, M.D.)
Staff-Years:
1.9
Human Subjects:
x (a) Human subjects (b) Human tissues (c) Neither
(a1) Minors (a2) Interviews
Summary of Work: This protocol was developed as a companion protocol to #98-CC-0123. It allows us to study the reproductive effects of raloxifene in premenopausal women by transvaginal color Doppler sonography and sonohysterography with correlation to steroid hormones. Raloxifene is a selective estrogen modulating agent that is being evaluated as a potential chemopreventive agent in patients at high risk for breast cancer. The safety and efficacy of raloxifene are being evaluated under protocol #98-CC-0123. Little data is available regarding the gynecological effects of raloxifene in premenopausal women. The purpose of our study is to study both the short-term and the long-term effects of raloxifene on ovulation frequency, endometrial development, and cyclic function in general.
The study started enrolling patients in January 1999. There are 14 patients enrolled currently. No complications have been encountered so far and we plan to continue this study.
INTRAMURAL
RESEARCH PROJECT
Z01 CL-00081-02 DRD
October 1, 1999 to September 30, 2000
Title of Project:
Evaluation of Treated and Untreated Stroke
Principal Investigator:
A.P. Dagher, M.D.
CC, NIH
Bethesda, MD 20892
Other Personnel:
N.J. Patronas, M.D., DRD
J.A. Frank, M.D., LDRR
J. Duyn, Ph.D., LDRR
Collaborating Units:
Suburban Hospital (W.J. Olan, M.D.)
NINDS (J.M. Hallenbeck, M.D.; T. DeGraba, M.D.; M. Hallett, M.D.)
Staff-Years:
2.1
Human Subjects:
x (a) Human subjects (b) Human tissues (c) Neither
(a1) Minors (a2) Interviews
Summary of Work: This project will investigate the evolution of treated and untreated stroke in patients recruited from the collaborative brain stroke program between NINDS, the Clinical Center and Suburban Hospital. The study will use anatomical and functional imaging techniques with emphasis on the acute and subacute stage (less than 1 month) of the disease. During the acute phase (less than 6 hours post-ictus) and following up at 12, 24, and 48 hours and at 2 to 4 weeks we will perform the study using various pulse sequences to define temporal relationships. From these pulse sequences, several voxel maps (and their putative significance) will be created. Magnetic resonance angiograms will be evaluated for stenosis according to the NASCET criteria for the internal carotid arteries and similar percent stenosis for other vessels. Region of Interest analysis will be performed on these maps. An analysis of variances (ANOVA) will be used to evaluate the significance of the differences among volume measurements from these parameters. Parallel to this analysis will be a normalization of results from all pulse sequences into Talairach space (Brain Atlas) while preserving tissue volumetric units (i.e., the size of the lesion). This framework allows correlation of location and intensity of the parametric information from any pulse sequence with underlying morphological information or parametric information from any other pulse sequence as well. Signal and volumetric changes with time will also be analyzed.
We will begin to enroll subjects. For the first 6 months, we will only enroll subjects who are capable of providing valid informed consent. After 6 months, we will report on our progress and experience with obtaining consent in the emergency room setting to the National Institute of Neurological Disorders and Stroke Institutional Review Board.
INTRAMURAL
RESEARCH PROJECT
Z01 CL-00082-02 DRD
October 1, 1999 to September 30, 2000
Title of Project:
Contrast-enhanced Magnetic Resonance Angiography in the Diagnosis of Atherosclerotic
Disease: A Pilot Technical Development Study
Principal Investigator:
P.L. Choyke, M.D.
DRD, CC, NIH
Bethesda, MD 20892
Other Personnel:
R.M. Summers, M.D., DRD
Y. Zhang, Ph.D., DRD
P. Yim, Ph.D., DRD
Collaborating Units:
USUHS (V.B. Ho, M.D.)
VA Medical Center (B. Pastakia, M.D.)
Mt. Vernon Cardiology (A. Moalemi, M.D.)
Georgetown Univ. (M. Gomes, M.D.; C. Lundergan, M.D.)
General Electric Medical Systems (T. Foo, Ph.D.)
Suburban Hospital (B. Dick, M.D., Chief, Interventional Radiology)
Staff-Years:
1.6
Human Subjects:
x (a) Human subjects (b) Human tissues (c) Neither
(a1) Minors
(a2) Interviews
Summary of Work: The purpose of this protocol is to test technical improvements in magnetic resonance angiography (MRA). The patient population of the Clinical Center does not provide a large number of patients on which to develop MRA techniques, yet, the DRD is occasionally asked to provide diagnostic services on vascular disease. In order to improve our ability to respond to these requests we have initiated this protocol to recruit patients from the metropolitan Washington area who have peripheral vascular disease. To date, we have recruited 22 individuals with atherosclerosis. We have been able to investigate new methods of imaging these diseased vessels. For instance, we are evaluating time resolved (8-second) carotid MRAs using correlation imaging. We are evaluating high-resolution imaging of the calf vessels in order to improve the resolution of these small vessels. The results are as yet too preliminary but very promising. There have been no complications.
We plan to continue to recruit patients to this protocol over the coming year and anticipate large enough accruals to develop correlation imaging for the carotids and high resolution calf vessel imaging.
INTRAMURAL
RESEARCH PROJECT
Z01 CL-00083-02 DRD
October 1, 1999 to September 30, 2000
Title of Project:
Nuclear Magnetic Resonance Scanning on Patients
Principal Investigator:
P.L. Choyke, M.D.
DRD, CC, NIH
Bethesda, MD 20892
Other Personnel:
N.J. Patronas, M.D., DRD
Collaborating Unit:
None
Staff-Years:
15.0
Human Subjects:
x (a) Human subjects (b) Human tissues (c) Neither
(a1) Minors (a2) Interviews
Summary of Work: This study allows the testing of magnetic resonance imaging (MRI) scanning techniques prior to their approval by the Food and Drug Administration (FDA). The protocol permits MRIs performed at the Clinical Center to be operated in a "research mode" and has allowed the DRD to avail itself of developments as rapidly as possible to maintain the most up-to-date-menu of MRI diagnostic techniques for patient scanning. While there is no risk to the patient from these techniques, the FDA insists that patients who undergo scanning with pulse sequences, whose efficacy has not been unequivocally established, must be given informed consent and this process must be under the auspices of an Institute Review Board. This protocol has been in continuous use since 1984. In the past year we have scanned approximately 7,500 new subjects, without side effects or complications. For safety reasons, we have recently added to our checklist transdermal patches that have been reported to cause burns in MR units and surgical implants like IVC filters and ventriculo-peritoneal shunts that have sometimes caused severe artifacts. Since MRI technology continues to advance, we will continue to enroll subjects into this protocol.
INTRAMURAL
RESEARCH PROJECT
Z01 CL-00084-02 DRD
October 1, 1999 to September 30, 2000
Title of Project:
Diagnostic Efficacy of Virtual Bronchoscopy
Principal Investigator:
R.M. Summers, M.D., Ph.D.
DRD, CC, NIH
Bethesda, MD 20892
Other Personnel:
P.L. Choyke, M.D., DRD
M. Franaszek, Ph.D., DRD
Collaborating Units:
IR, NIAID (S.M. Holland, M.D.; M.C. Sneller, M.D.)
George Mason Univ. (J. Cebral, Ph.D.)
CC (J.H. Shelhamer, M.D.)
Staff-Years:
2.0
Human Subjects:
x (a) Human subjects (b) Human tissues (c) Neither
(a1) Minors (a2) Interviews
Summary of Work: This project is a test of the efficacy of a new diagnostic method for imaging the airways known as virtual bronchoscopy. Virtual Bronchoscopy is performed by acquiring thin section computer tomography (CT) images of the chest. These images are used to generate a three-dimensional (3D) model of the tracheal and bronchial walls on a graphics workstation in 3D. The model can be manipulated to allow the viewer to "fly-through" the tracheobronchial tree providing views similar to those obtained using bronchoscopy. The technique produces a display of the human bronchial system in a readily understood format. Moreover, it allows investigation of post-stenotic portions of the bronchial tree that are beyond the reach of fiberoptic bronchoscopy. Further, virtual bronchoscopy may be used to guide interventional procedures. The patients that will be studied in this protocol will be those having inflammatory, infectious, or neoplastic pulmonary processes who would have had chest CT for clinical reasons. These patients will be recruited from current NIH protocols. The study design consists of scanning of the thorax using thin section helical CT, followed by three dimensional surface rendering of the airways and transfer of the digital data to videotape. In one of four parts of the protocol, the virtual bronchoscopy will be compared with results from fiberoptic bronchoscopy in a blinded study. In a second part of the protocol, the virtual bronchoscopy will be used to perform a descriptive analysis of cavity lung lesions. In the third part, the utility of virtual bronchoscopy in diagnosis of neoplastic lesions of the chest will be studied. In the fourth part, certain technical problems in the virtual bronchoscopy procedure will be investigated. The patients will only have fiberoptic bronchoscopy for clinically indicated purposes. We anticipate that virtual bronchoscopy will be diagnostically efficacious for disorders which produce a morphologic alteration in bronchial anatomy. There have been no complications. Virtual bronchoscopy has been shown to be useful for detecting stenoses. We now have access to a CT scanner with higher Z-axis resolution and are investigating its efficacy for virtual bronchoscopy.
INTRAMURAL
RESEARCH PROJECT
Z01 CL-00085-02 DRD
October 1, 1999 to September 30, 2000
Title of Project:
Normal Volunteer Scanning on Magnetic Resonance
Principal Investigator:
P.L. Choyke, M.D.
DRD, CC, NIH
Bethesda, MD 20892
Other Personnel:
R.M. Summers, M.D., Ph.D., DRD
N.J. Patronas, M.D., DRD
A.P. Dagher, M.D., Ph.D., DRD
J. Butman, M.D., DRD
V.B. Ho, M.D., Uniformed Services Univ., Dept. of Radiology
Collaborating Unit:
None
Staff-Years:
2.0
Human Subjects:
x (a) Human subjects (b) Human tissues (c) Neither
(a1) Minors (a2) Interviews
Summary of Work: The purpose of this protocol is to develop novel methods of performing magnetic resonance imaging (MRI) evaluations so that these methods can be transferred to the clinical environment. Normal volunteers are recruited to optimize imaging techniques and the protocol has been very successful in recruiting normal volunteers. Among the accomplishments of this protocol over the last year include optimizing contrast administration rates during magnetic resonance angiograms, automatic table motion techniques for peripheral run-off magnetic resonance angiography (MRAs), phase contrast angiography, motion tracking for knee and patella movement, functional MRI of the brain, gated MRI to image the soft palate, and stroke protocols. We have made substantial gains in technical development in all of these areas and there have been no complications. Abstracts and publications have been presented or are in the process of peer review. We have developed protocols to be used in conjunction with Suburban Hospital in MRA, stroke, and cardiac imaging, and will continue this study.
INTRAMURAL
RESEARCH PROJECT
Z01 CL-00086-02 DRD
October 1, 1999 to September 30, 2000
Title of Project:
Examination of the Hemodynamics of the Portal Venous System in Normal Volunteers
Using Magnetic Resonance Imaging
Principal Investigator:
E.C. Jones, M.D.
DRD, CC, NIH
Bethesda, MD 20892
Other Personnel:
W.F. Pritchard, M.D., DRD
Collaborating Units:
BEIP, NCRR (R.J. Lutz)
NIDDK (R.T. Jensen, M.D.; M. Skarulis, M.D.)
Staff-Years:
1.8
Human Subjects:
x (a) Human subjects (b) Human tissues (c) Neither
(a1) Minors (a2) Interviews
Summary of Work: There are three components of the study: technical development to define the imaging protocol; conduct the observational study of blood flow patterns in study subjects; define the anatomy and flow parameters for construction of flow models. The development of the principal imaging protocol is complete; the portal anatomy and flow patterns can be reproducibly imaged. During the period of technical development, we have observed evidence of the phenomenon of blood streaming which is the central hypothesis of our study.
The observational study of subjects after fasting and after a meal started July 1999. We have accrued 22 volunteers to date. Preliminary anatomic and flow data has been collected for model construction; a preliminary model has been constructed. The magnetic resonance examinations of the patients enrolled in the pivotal study are completed; data analysis is underway.
INTRAMURAL
RESEARCH PROJECT
Z01 CL-00087-01 DRD
October 1, 1999 to September 30, 2000
Title of Project:
Comparison of Contrast-enhanced Magnetic Resonance Angiography and Conventional
Angiography in the Diagnosis of Atherosclerotic Disease: A Pilot Study
Principal Investigator:
P.L. Choyke, M.D.
DRD, CC, NIH
Bethesda, MD 20892
Other Personnel:
H. Marcos, M.D., DRD
S. Jones, R.N., M.S., DRD
A. Arai, M.D., NHLBI
B. Dick, M.D., Dept. of Radiology, Suburban Hospital
W. Olan, M.D., Dept. of Radiology, Suburban Hospital
Collaborating Unit:
None
Staff-Years:
0.1
Human Subjects:
x (a) Human subjects (b) Human tissues (c) Neither
(a1) Minors (a2) Interviews
Summary of Work: This study will evaluate ways to improve magnetic resonance angiography (MRA) for diagnosing atherosclerosis. Patients with atherosclerosis who have had conventional angiography at Suburban Hospital in Bethesda, Maryland, will be considered for this study. Those enrolled will have a MRA scan at Suburban Hospital within 72 hours of their conventional angiogram. This protocol enables state-of-the-art technology developed in the Diagnostic Radiology Department, Clinical Center to be applied to patients with atherosclerotic disease with angiographic correlation. We are currently investigating improved methods of k-space ordering to allow rapid scanning of the run-off vessels while obtaining high resolution images of the vessels. Additional investigations will include real time MR "fluoroscopy" to provide better timing of the MR during intravenous gadolinium chelate administration. Improvements in the MRA "package" may allow substitution of MRA for conventional catheter angiography in the near future.
INTRAMURAL
RESEARCH PROJECT
Z01 CL-00088-01-DRD
October 1, 1999 to September 30, 2000
Title of Project:
Use of the "Intraoperative" Quick Parathyroid Hormone Assay During Parathyroid
Venous Sampling
Principal Investigator:
R. Chang, M.D.
DRD, CC, NIH
Bethesda, MD 20892
Other Personnel:
None
Collaborating Units:
NIDDK (A.M. Spiegel, M.D.; S.J. Marx, M.D.; M.C. Skarulis, M.D.)
CPI, CC (A. Remaley, M.D.)
Staff-Years:
1.0
Human Subjects:
x (a) Human subjects (b) Human tissues (c) Neither
(a1) Minors (a2) Interviews
Summary of Work: Parathyroid venous sampling remains the most precise localization technique for patients with failed parathyroid surgery but it requires considerable experience on the part of the angiographer as well as prolonged catheter manipulation to sample the multiple small veins draining the neck and mediastinum. Knowledge of the presence of parathyroid hormone (PTH) gradients during the procedure would enable the angiographer to focus on a specific area, perhaps obtaining more detailed samples and to shorten the procedure when significant gradients occur in the early samples. This protocol will not increase the accuracy of sampling but will shorten the procedure, reduce radiation exposure to the patient and to the interventional radiologist and allow more precise localization by more focused sampling.
We plan to use the quick PTH assay originally developed by Nichols' Lab for intraoperative use to inform the surgeon when all abnormal parathyroid tissue has been resected. However as we would be assaying multiple PTH samples on line and the assay is not cheap, we have been collaborating with Nichols to develop a more sensitive, less expensive rapid PTH assay. This has recently been accomplished and Nichols' Lab has agreed to provide assay kits at cost for our investigation. Although no patients have been accrued to this protocol thus far, on-line PTH assays during parathyroid venous sampling will be a useful clinical addition to the work-up of patients with occult parathyroid adenomas and we plan to continue this protocol.
Index:
Annual Report of Clinical Research Activities FY 2000
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