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NCT01574287 · ClinicalTrials.gov registry record · NA
Anti-3-[18F]FACBC Imaging of Parathyroid Adenomas
A NA study, sponsored by David M. Schuster, MD.
- Completed
- Registry status
- NA
- Development phase
- 4
- Enrollment target
NCT01574287: Completed NA study, sponsored by David M. Schuster, MD.
NCT01574287 is a NA study that has completed, run by David M. Schuster, MD. The registered enrollment target is 4 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01574287, a NA study, has completed, sponsored by David M. Schuster, MD.
- COMPLETED
- Registry status
- NA
- Development phase
- 4 participants
- Enrollment target
Study Summary
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
Primary Outcome
Detection rate of parathyroid adenomas using anti-3-\[18F\]FACBC modality is assessed by comparing \[18F\]FACBC and surgical findings.
Interventions
- DRUG FACBC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2012-08 |
| Est. Completion | 2019-05-15 |
| Phase | NA |
What the finished NCT01574287 record still lists
NCT01574287 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which FACBC is the first listed.
NCT01574287 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01574287 about?
NCT01574287 is a clinical study titled "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;...
What is the current status of trial NCT01574287?
This trial is currently completed. It is a NA study. The enrollment target is 4 participants. The study started on 2012-08. Estimated completion is 2019-05-15.
What interventions are being tested in trial NCT01574287?
The interventions under investigation include: FACBC (DRUG).
Who is sponsoring clinical trial NCT01574287?
This trial is sponsored by David M. Schuster, MD, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01574287's enrollment target sits among peer trials
4 1996th of 2000 higher than 5 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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