F-18 PSMA for Localization of Parathyroid Adenoma

Stopped early

Conditions studied: Hyperparathyroidism

In brief

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.

Key facts

Study ID

NCT05299632

Run by

Emory University

People needed

3

Starts

2022-03-31

Expected to finish

2022-05-09

Last updated by the study team

2025-05-09

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must be 18 years of age or older.
• Patients will have biochemical and/or clinical evidence of primary hyperparathyroidism and be a surgical candidate for definitive parathyroid surgery.
• Ability to lie still for SPECT/CT and PET/CT scanning
• Patients must be able to provide written informed consent

You may not qualify if…

• Age less than 18.
• Inability to lie still for SPECT/CT and PET/CT scanning.
• Cannot provide written informed consent.
• History of secondary hyperparathyroidism.
• Positive serum or urine pregnancy test within 24 hours of imaging

Where it is running

• Emory Saint Joseph's Hospital — Atlanta, Georgia, United States
• Emory University Hospital (EUH) — Atlanta, Georgia, United States
• Emory Johns Creek Hospital — Johns Creek, Georgia, United States

Full record on ClinicalTrials.gov

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