99mTc Sestamibi SPECT/CT vs 18F Fluorocholine PET/CT

• Status: Not yet recruiting
• Trial end date: 2027-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study proposes the use of a well-established PET isotope, Fluorine-18 (18F), bound to Choline, for a prospective single-center, single-arm study for participants with suspected parathyroid adenoma and negative or equivocal standard of care 99mTc Sestamibi SPECT/CT

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Andrei Iagaru

Criteria

Inclusion Criteria:

1. Suspected parathyroid adenoma (elevated serum calcium and inappropriately normal or high levels of parathyroid hormone)

2. Negative or equivocal 99mTc Sestamibi SPECT/CT

3. Able to provide written consent

4. Total bilirubin ≤ 1.5 x upper limit of normal (ULN)

5. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 5 xULN

6. Karnofsky performance status of >50 (or ECOG/WHO equivalent)

7. Women must not be pregnant per the Department of Radiology Policy on Imaging in Potentially Pregnant and Pregnant Women.

Exclusion Criteria:

1. Less than 18 years old at the time of radiotracer administration

2. Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 60 mL/min or serum creatinine >1.5 x ULN

3. QTcF >470 msec on electrocardiogram (ECG) or congenital long QT syndrome