Anti-3-[18F]FACBC Imaging of Parathyroid Adenomas
Hyperparathyroidism (excessive production of parathyroid hormone (PTH) usually caused by a small growth called an adenoma in the parathyroid glands) is an increasingly significant medical and public health condition.
Surgery is the only effective management for primary hyperparathyroidism. However; it is sometimes difficult to pinpoint the adenoma, in part because current methods of imaging often fail to identify the parathyroid adenoma in as many as 30% of patients. In reoperative parathyroidectomy for persistent or recurrent hyperparathyroidism, localization plays an even greater role. Unfortunately current multiple imaging methods fail to localize 10-15% these of tumors.
SPECT/CT with the radiotracer 99mTc sestamibi has become the standard method for pinpointing the tumor. This, however, is a challenge because the parathyroid glands usually are located close to the thyroid and the radiotracer 99mTc sestamibi concentrates both in thyroid and parathyroid tissue. Hence there is a need for a tracer/imaging tool that concentrates in the parathyroid but not in the thyroid.
A more sensitive and specific radiotracer/tracking agent would markedly improve the investigators ability to identify parathyroid tumors preoperatively, and thus offer more patients a minimally invasive parathyroidectomy.
anti-3-[18F]FACBC is an amino acid based PET radiotracer which has shown utility in detecting a variety of tumors. In cell culture experiments, anti-3-[18F]FACBC has shown uptake in parathyroid cells greater than thyroid cells. Therefore, the investigators think that this radiotracer may be able to help us identify parathyroid adenomas better than 99mTc sestamibi.
The primary aim of this study is to determine if anti-3-[18F]FACBC PET-CT demonstrates uptake within parathyroid adenomas. 12 patients with a diagnosis of primary hyperparathyroidism will undergo PET-CT using anti-3-[18F]FACBC in addition to the standard 99mTc sestamibi scanning and other imaging as clinically appropriate such as ultrasound, MRI, and/or contrast enhanced CT scanning. Since all these patients undergo surgery routinely, the investigators will then compare findings at surgery to those of the anti-3-[18F]FACBC PET-CT to determine if this radiotracer is worthy of further study in a more comprehensive experiment.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Amino Acid Transport Imaging of Parathyroid Adenomas With Anti-3-[18F]FACBC|
- Correlate uptake of anti-3-[18F]FACBC to surgical findings of parathyroid adenomas [ Time Frame: At approximately 1 month post scan (time of surgery and pathologic analysis) ] [ Designated as safety issue: No ]To evaluate if anti-3-[18F]FACBC can detect parathyroid adenomas.
- Measure uptake mechanisms of anti-3-[18F]FACBC in parathyroid adenomas [ Time Frame: At approximately 1 month post scan (time of surgery and pathologic analysis) ] [ Designated as safety issue: No ]To evaluate uptake mechanisms and specific amino acid transporter regulation of anti-3-[18F]FACBC in parathyroid adenomas.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||September 2017|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Drug is give intravenously over 2 minutes at time of scan
Please refer to this study by its ClinicalTrials.gov identifier: NCT01574287
|United States, Georgia|
|Atlanta, Georgia, United States, 30032|
|Contact: Leah Bellamy, RN, MSN 404-712-7965 firstname.lastname@example.org|
|Contact: David Schuster, MD 404-712-4859 email@example.com|
|Sub-Investigator: Colin Weber, MD|
|Sub-Investigator: Raghu Halkar, MD|
|Sub-Investigator: Jyotirmay Sharma, MD|
|Principal Investigator:||David M Schuster, MD||Emory University|