F-18 PSMA for Localization of Parathyroid Adenoma

NCT05299632 | Terminated

• 1 other identifier: STUDY00003262
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (5)

• Preoperative localization of the parathyroid adenoma by F-18-PSMA PET/CT

  Results of F-18 PSMA imaging regarding localization will be compared to surgical findings (Right: superior, inferior and/or Left: superior, inferior)

  Up to 14 days after surgical removal of parathyroid adenoma

• Preoperative size (mm) of the parathyroid adenoma by F-18-PSMA PET/CT

  Results of F-18 PSMA imaging will be compared to surgical findings described in the operative notes in the EMR

  Up to 14 days after surgical removal of parathyroid adenoma

• The sensitivity of the F-18-PSMA PET/CT uptake correlation with other pathologic criteria

  The lesion-based sensitivities of F-18-PSMA PET/CT uptake using surgical pathology of the parathyroid gland as the reference standard (The number of true positive image findings/The number of pathologically confirmed parathyroid adenoma or hyperplasia)

  Up to 14 days after surgical removal of parathyroid adenoma

• The specificity of the F-18-PSMA PET/CT uptake correlation with other pathologic criteria

  The lesion-based specificity of F-18-PSMA PET/CT uptake using surgical pathology of the parathyroid gland as the reference standard (The number of true negative image findings/The number of negative findings on surgical pathology)

  Up to 14 days after surgical removal of parathyroid adenoma

• The accuracies of the F-18-PSMA PET/CT uptake correlation with other pathologic criteria

  The lesion-based accuracy of the F-18-PSMA PET/CT uptake using surgical pathology of the parathyroid gland as reference standard (True positive and true negative image findings/The number of all surgical specimens)

  Up to 14 days after surgical removal of parathyroid adenoma

Study Arms (1)

Patients with biochemical and clinical evidence of primary hyperparathyroidism

Patients who have biochemical and clinical evidence of primary hyperparathyroidism and who are scheduled for routine surgery and preoperative imaging including 99mTc-MIBI planar imaging and SPECT/CT. Subjects who enroll in the study will receive one additional F-18PSMA PET/CT imaging study. F-18 PSMA imaging study will be scheduled on the same day as of the Tc-99m MIBI scan. Since F-18 PSMA PET/CT employs 511kEv annihilation photon, the lower energy if (140 KeV) of Tc-99m MIBI will not interfere.

Diagnostic Test: 99mTc-MIBI planar imaging and SPECT/CT.; Diagnostic Test: F- 18PSMA PET/CT imaging study

Interventions

99mTc-MIBI planar imaging and SPECT/CT. DIAGNOSTIC_TEST

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.

Also known as: Standard of Care

Patients with biochemical and clinical evidence of primary hyperparathyroidism

F- 18PSMA PET/CT imaging study DIAGNOSTIC_TEST

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.

Also known as: F- 18PSMA PET/CT

Patients with biochemical and clinical evidence of primary hyperparathyroidism

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have agreed for Tc-99m MBI parathyroid imaging and parathyroidectomy will be identified as potential participants

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

Sponsors & Collaborators

• Emory University: lead

Study Sites (3)

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30308, United States

Location

Emory University Hospital (EUH)

Atlanta, Georgia, 30322, United States

Location

Emory Johns Creek Hospital

Johns Creek, Georgia, 30097, United States

Location

MeSH Terms

Conditions

Hyperparathyroidism

Interventions

Single Photon Emission Computed Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed, Single-Photon; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Raghuveer Halkar, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine: Radiology

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 29, 2022
• Study Start: March 31, 2022
• Primary Completion: May 9, 2022
• Study Completion: May 9, 2022
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)