Parathyroid AdenomaDrugPhase 2, Phase 3
What this study is
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
What's being tested
- 18Fluorocholine
Intervention · DRUG
18F Fluorocholine 5 mCi ± 20% administered intravenously.
Study details
- Official title
- Evaluation of Patients With Suspected Parathyroid Adenoma and Negative or Equivocal 99mTc Sestamibi SPECT/CT Using 18F Fluorocholine PET/CT
- Sponsor
- Andrei Iagaru
- Conditions
- Parathyroid Adenoma
- Enrolling
- 100 people
- Starts
- 2023-09-27
- Est. completion
- 2028-07-01
- Design
- Open-label, single group, Phase 2, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- Less than 18 years old at the time of radiotracer administration
- Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 60 mL/min or serum creatinine >1.5 x ULN
- QTcF >470 msec on electrocardiogram (ECG) or congenital long QT syndrome
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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1
Study locations (1)
1 openStanford Hospital and Clinics
Stanford, California, United States
- Meredith Durbahn · Contactmdurbahn@stanford.edu
- Andrei Iagaru, MD · Principal investigator
Recruiting
Study team
Sponsor
Andrei Iagaru
Study ID 68169
Study director
Andrei Iagaru, MD
Stanford University
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.