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NCT05891769 | RECRUITING | Parathyroid Adenoma

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

Andrei Iagaru

Information provided by (Responsible Party):

Andrei Iagaru

Brief 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

Condition or disease

Parathyroid Adenoma

Intervention/treatment

18Fluorocholine

Phase

PHASE2

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Evaluation of Patients With Suspected Parathyroid Adenoma and Negative or Equivocal 99mTc Sestamibi SPECT/CT Using 18F Fluorocholine PET/CT
Actual Study Start Date : 2023-09-27
Estimated Primary Completion Date : 2026-07-01
Estimated Study Completion Date : 2027-07-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
99mTc Sestamibi SPECT/CT vs 18F Fluorocholine PET/CT

Location Details

NCT05891769

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How to Participate

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Locations

RECRUITING

United States, California

Stanford Hospital and Clinics

Stanford, California, United States, 94305