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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
18Fluorocholine
Drug18F Fluorocholine 5 mCi ± 20% administered intravenously.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: 18FCH PET/CTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of lesions detected by PET/CT for detecting parathyroid adenomas.
Inclusion criteria suggest recruiting patients with negative or equivocal SPECT/CT, so based on this there will be 0 lesions on SPECT/CT. The goal is to compare/count the number of lesions from PET/CT, if any present versus no lesions with SPECT/CT
Time frame
up to 1 hourSponsors and contacts
Click on the lead sponsor to view all of their trials.
Andrei Iagaru
Lead sponsor
Stanford University
Sponsor institution
Source ClinicalTrials.gov