RecruitingPhase 2/3

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

United States100 participantsStarted 2023-09-27

Plain-language 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

Age range18 Years

SexALL

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Inclusion criteria

✓. Suspected parathyroid adenoma (elevated serum calcium and inappropriately normal or high levels of parathyroid hormone)
✓. Negative or equivocal 99mTc Sestamibi SPECT/CT
✓. Able to provide written consent
✓. Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
✓. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 5 xULN
✓. Karnofsky performance status of \>50 (or ECOG/WHO equivalent)
✓. Women must not be pregnant per the Department of Radiology Policy on Imaging in Potentially Pregnant and Pregnant Women.

Exclusion criteria

✕. Less than 18 years old at the time of radiotracer administration
✕. Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) \< 60 mL/min or serum creatinine \>1.5 x ULN
✕. QTcF \>470 msec on electrocardiogram (ECG) or congenital long QT syndrome

What they're measuring

Number of lesions detected by PET/CT for detecting parathyroid adenomas.

Timeframe: up to 1 hour

Trial details

NCT IDNCT05891769

SponsorAndrei Iagaru

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-01

Contact for this trial

Andrea Otte, DPT

650-736-4183 anotte@stanford.edu

View on ClinicalTrials.gov More Parathyroid Adenoma trials