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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Suspected parathyroid adenoma (elevated serum calcium and inappropriately normal or high levels of parathyroid hormone)

• Negative or equivocal 99mTc Sestamibi SPECT/CT

• Able to provide written consent

• Total bilirubin ≤ 1.5 x upper limit of normal (ULN)

• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 5 xULN

• Karnofsky performance status of \>50 (or ECOG/WHO equivalent)

• Women must not be pregnant per the Department of Radiology Policy on Imaging in Potentially Pregnant and Pregnant Women.

Locations
United States
California
Stanford Hospital and Clinics
RECRUITING
Stanford
Contact Information
Primary
Andrea Otte, DPT
anotte@stanford.edu
650-736-4183
Time Frame
Start Date: 2023-09-27
Estimated Completion Date: 2027-07-01
Participants
Target number of participants: 100
Treatments
Experimental: 18FCH PET/CT
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.
Related Therapeutic Areas
Sponsors
Leads: Andrei Iagaru

This content was sourced from clinicaltrials.gov

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