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

Trial ID or NCT#

NCT05891769

Status

not recruiting iconNOT RECRUITING

Purpose

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

Official Title

Evaluation of Patients With Suspected Parathyroid Adenoma and Negative or Equivocal 99mTc Sestamibi SPECT/CT Using 18F Fluorocholine PET/CT

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 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. 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
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Investigator(s)

Kip E. Guja, MD PhD
Clinical Instructor, Radiology - Rad/Nuclear Medicine
Andrei Iagaru
Andrei Iagaru
Radiologist
Professor of Radiology (Nuclear Medicine)

View on ClinicalTrials.gov