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Trial Title:
99mTc Sestamibi SPECT/CT vs 18F Fluorocholine PET/CT
NCT ID:
NCT05891769
Condition:
Parathyroid Adenoma
Conditions: Official terms:
Adenoma
Parathyroid Neoplasms
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
This is a prospective, single-center, single-arm study enrolling 100 adult participants
with suspected parathyroid adenoma and negative or equivocal standard of care 99mTc
Sestamibi SPECT/CT.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
18Fluorocholine
Description:
18F Fluorocholine 5 mCi ± 20% administered intravenously.
Arm group label:
18FCH PET/CT
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
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Stanford Hospital and Clinics
Address:
City:
Stanford
Zip:
94305
Country:
United States
Status:
Recruiting
Contact:
Last name:
Meredith Durbahn
Email:
mdurbahn@stanford.edu
Investigator:
Last name:
Andrei Iagaru, MD
Email:
Principal Investigator
Start date:
September 27, 2023
Completion date:
July 1, 2027
Lead sponsor:
Agency:
Andrei Iagaru
Agency class:
Other
Source:
Stanford University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05891769
