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99mTc Sestamibi SPECT/CT vs 18F Fluorocholine PET/CT
RECRUITINGPhase 2/3Sponsored by Andrei Iagaru
Actively Recruiting
PhasePhase 2/3
SponsorAndrei Iagaru
Started2023-09-27
Est. completion2026-07-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT05891769
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
Eligibility
Age: 18 Years+Healthy volunteers accepted
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 electrocardiogram (ECG) or congenital long QT syndrome
Conditions2
CancerParathyroid Adenoma
Interventions1
Locations1 site
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Actively Recruiting
PhasePhase 2/3
SponsorAndrei Iagaru
Started2023-09-27
Est. completion2026-07-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT05891769