Status:
RECRUITING
99mTc Sestamibi SPECT/CT vs 18F Fluorocholine PET/CT
Lead Sponsor:
Andrei Iagaru
Conditions:
Parathyroid Adenoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 adenom...
Eligibility Criteria
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
Key Trial Info
Start Date :
September 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05891769
Start Date
September 27 2023
End Date
July 1 2027
Last Update
September 10 2025
Active Locations (1)
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1
Stanford Hospital and Clinics
Stanford, California, United States, 94305