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

Description

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

Conditions

Parathyroid Adenoma

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Study Overview

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Study Details

Study 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

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

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

Condition
Parathyroid Adenoma
Intervention / Treatment

-

Contacts and Locations

Stanford

Stanford Hospital and Clinics, Stanford, California, United States, 94305

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Andrei Iagaru,

Andrei Iagaru, MD, STUDY_DIRECTOR, Stanford University

Study Record Dates

2027-07-01