99mTc Sestamibi SPECT/CT vs 18F Fluorocholine PET/CT (18FCH)

Andrei Iagaru

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Parathyroid Adenoma

Treatments: Drug: 18Fluorocholine

Study type: Interventional

Funder types: Other

Identifiers

NCT05891769

68169

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

18FCH PET/CT

Experimental group

Description:

Participant receive 18F Fluorocholine injection and approximately 45-60 minutes later receive a low dose CT scan from skull base to mid thighs, followed by a static PET emission scan over the same area.

Treatment:

Drug: 18Fluorocholine