99mTc Sestamibi SPECT/CT vs 18F Fluorocholine PET/CT
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
| Condition(s) | Parathyroid Adenoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Study type | Interventional |
| 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 |
| Who can participate | 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 electrocardiog |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Andrei Iagaru |
| Locations | Stanford, California, United States |
| Start date | 2023-09-27 |
| NCT ID | NCT05891769 |
| Official listing | https://clinicaltrials.gov/study/NCT05891769 |