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99mTc Sestamibi SPECT/CT vs 18F Fluorocholine PET/CT

Recruiting
18 years of age
Both
Phase 2/3

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Overview

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

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

Study details

Parathyroid Adenoma

NCT05891769

Andrei Iagaru

1 May 2024

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