Comparing two imaging techniques for detecting parathyroid adenoma
Evaluation of Patients With Suspected Parathyroid Adenoma and Negative or Equivocal 99mTc Sestamibi SPECT/CT Using 18F Fluorocholine PET/CT
PHASE2; PHASE3 · Stanford University · NCT05891769
This study is testing a new imaging method to see if it can better find parathyroid adenomas in patients who haven't had clear results from the standard imaging technique.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stanford University (other) |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT05891769 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of 18F Fluorocholine PET/CT in patients with suspected parathyroid adenoma who have had negative or inconclusive results from the standard 99mTc Sestamibi SPECT/CT. It is a prospective, single-center, single-arm study aimed at improving diagnostic accuracy for this condition. Participants will undergo imaging with the new radiotracer to determine its efficacy in identifying parathyroid adenomas. The study is designed to gather data on the performance of this imaging technique compared to the established method.
Who should consider this trial
Good fit: Ideal candidates are adults with suspected parathyroid adenoma and negative or equivocal results from previous imaging.
Not a fit: Patients under 18 years old or those with significant renal impairment or long QT syndrome may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses of parathyroid adenomas, allowing for better-targeted treatments.
How similar studies have performed: While there have been studies on imaging techniques for parathyroid adenomas, the specific use of 18F Fluorocholine PET/CT in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Stanford, California
- Stanford Hospital and Clinics — Stanford, California, United States (RECRUITING)
Study contacts
- Study coordinator: Andrea Otte, DPT
- Email: anotte@stanford.edu
- Phone: 650-736-4183
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Parathyroid Adenoma