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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

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

Locations1 site

Stanford Hospital and Clinics
Stanford, California, 94305
Meredith Durbahnmdurbahn@stanford.edu

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