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NCT05299632 · ClinicalTrials.gov registry record
F-18 PSMA for Localization of Parathyroid Adenoma
A clinical trial, sponsored by Emory University.
- Terminated
- Registry status
- 3
- Enrollment target
NCT05299632: Clinical Trial study, sponsored by Emory University.
NCT05299632 is a clinical trial that was terminated before completion, run by Emory University. The registered enrollment target is 3 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05299632 was terminated before completion, sponsored by Emory University.
- TERMINATED
- Registry status
- 3 participants
- Enrollment target
Study Summary
Parathyroid glands are in the neck and produce a substance called parathormone which maintains the calcium level in the blood. Sometimes one or more of the parathyroid glands become hyperactive and produce too much parathormone which causes increased calcium in the blood which can cause ill effects on multiple parts of the body. Hyperactive glands are identified by Tc-99m Sestamibi (MIBI) scan which helps the surgeons to remove them with minimal risk to the patient. But about 30% of the time MIBI scan does not localize the hyperactive gland. There is some evidence that a new agent called F-18 PSMA (prostate-specific membrane antigen) can localize hyperactive parathyroid. This study is being done to collect preliminary data to answer the question: Can imaging with the PET tracer, F-18 PSMA (Pylarify), prior to parathyroid surgery, provide better information to a surgeon than the standard of care imaging with MIBI scan? Patients who are scheduled for parathyroidectomy and are scheduled for imaging with MIBI scan prior to surgery will be asked to take part in this study. This is a single institutional study to collect preliminary data to help do a larger study. Participants will get MIBI scan first, and the same day will get an F-18 PSMA scan which involves an injection in the vein, waiting an hour, and imaging of the neck and chest area for 10 minutes. The findings of F-18 PSMA will not interfere with the participant's management. Patients who participate will not directly benefit by participating in this study. If the scanning method using F-18 PSMA shows better results than MIBI scan (standard of care) then the investigators will conduct a larger multi-institutional study. If the results prove that F-18 PSMA is better than the standard of care in the larger study, then patients with hyperactive parathyroid patients in the future will benefit.
Primary Outcome
Results of F-18 PSMA imaging regarding localization will be compared to surgical findings (Right: superior, inferior and/or Left: superior, inferior)
Interventions
- DIAGNOSTIC_TEST 99mTc-MIBI planar imaging and SPECT/CT.
- DIAGNOSTIC_TEST F- 18PSMA PET/CT imaging study
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2022-03-31 |
| Est. Completion | 2022-05-09 |
Why NCT05299632 stopped before completion
NCT05299632 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 3 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which 99mTc-MIBI planar imaging and SPECT/CT. is the first listed.
NCT05299632 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05299632 about?
NCT05299632 is a clinical study titled "F-18 PSMA for Localization of Parathyroid Adenoma". Parathyroid glands are in the neck and produce a substance called parathormone which maintains the calcium level in the blood. Sometimes one or more of the parathyroid glands become hyperactive and produce too much parathormone which causes increased calcium in the blood which can cause ill effects ...
What is the current status of trial NCT05299632?
This trial is currently terminated. The enrollment target is 3 participants. The study started on 2022-03-31. Estimated completion is 2022-05-09.
What interventions are being tested in trial NCT05299632?
The interventions under investigation include: 99mTc-MIBI planar imaging and SPECT/CT. (DIAGNOSTIC_TEST), F- 18PSMA PET/CT imaging study (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05299632?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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