Evaluation of Patients With Suspected Parathyroid Adenoma and Negative or Equivocal 99mTc Sestamibi SPECT/CT Using 18F Fluorocholine PET/CT

68169

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

2023-09-27

2026-07-01

2027-07-01

Recruiting

Early phase I

100

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a prospective, single-center, single-arm study enrolling 100 adult participants with suspected parathyroid adenoma and negative or equivocal standard of care 99mTc Sestamibi SPECT/CT.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

2024-04-17