NCT05891769 · Andrei Iagaru
99mTc Sestamibi SPECT/CT vs 18F Fluorocholine PET/CT
(18FCH)
What this study is about
This study proposes the use of a well-established PET isotope, Fluorine-18 (18F), bound to Choline, for a forward-looking single-center, single-treatment group$1 study for participants with suspected parathyroid adenoma and negative or equivocal the usual treatment 99mTc Sestamibi SPECT/CT
View original scientific description
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
Interventions
DRUG
18Fluorocholine
18F Fluorocholine 5 mCi ± 20% administered intravenously.
Primary outcome measures
Number of lesions detected by PET/CT for detecting parathyroid adenomas.
Time frame: up to 1 hour
Inclusion criteria suggest recruiting patients with negative or equivocal SPECT/CT, so based on this there will be 0 lesions on SPECT/CT. The goal is to compare/count the number of lesions from PET/CT, if any present versus no lesions with SPECT/CT
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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
Where
- Stanford, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 24, 2026 · Source of record for eligibility and locations