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F-18 PSMA for Localization of Parathyroid Adenoma

NCT05299632 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 3

Last updated 2025-05-09

No results posted yet for this 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.

Conditions

  • Hyperparathyroidism

Interventions

DIAGNOSTIC_TEST

99mTc-MIBI planar imaging and SPECT/CT.

Participants will undergo a Tc-MIBI scan and management will be as per the finding of the Tc MIBI scan which is the standard of care.

DIAGNOSTIC_TEST

F- 18PSMA PET/CT imaging study

F-18 PSMA is an FDA-approved imaging agent used for PET/CT for evaluating metastatic prostate cancer. The findings of the images of F-18 PSMA will be shared with the referring /treating surgeon. However, the findings will not influence the management.

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Raghuveer Halkar, MD · Emory University

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-31
Primary Completion
2022-05-09
Completion
2022-05-09

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05299632 on ClinicalTrials.gov