99mTc Sestamibi SPECT/CT vs 18F Fluorocholine PET/CT
ConditionParathyroid Adenoma
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAndrei Iagaru
About this trial
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
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- 18Fluorocholine
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Andrei Iagaru
Lead sponsor
Stanford University
Sponsor institution
Source ClinicalTrials.gov