Phase 3
N=98
18F-Fluorocholine for the Detection of Parathyroid Adenomas
Hyperparathyroidism, Primary
Bottom Line
View on ClinicalTrials.gov: NCT03764007 ↗Enrolled (actual)
98
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: Proportion of True Positives for the Overall Detection of the Abnormal Parathyroid Adenoma — 0.75 proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 18F-Fluorocholine (Drug); Positron Emission Tomography (PET) (Procedure)
- Age
- Pediatric, Adult, Older Adult · 13+ yrs
- Sex
- All
- Sponsor
- Thomas Hope
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of True Positives for the Overall Detection of the Abnormal Parathyroid Adenoma |
0.75 | — |
| PRIMARY Proportion of True Positives for the Detection of the Abnormal Parathyroid Adenoma Using Sestamibi Imaging |
0.70 | — |
| SECONDARY Detection Rate in Patients Who Have Not Undergone Surgical Resection |
0.90 | — |
Summary
The investigators are studying the ability of F18 labeled fluorocholine PET to localize parathyroid adenomas in patients with hyperparathyroidism prior to surgery.
Eligibility Criteria
Inclusion Criteria
- Biochemically proven hyperparathyroidism and an indication for surgery
- Age >= 13 years old
- Karnofsky performance status of > 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent).
- Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion Criteria
- Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET scanner due to BMI.
- Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.).
- Inability to complete the needed investigational due to other reasons (severe claustrophobia, radiation phobia, etc.).
- Pregnancy.
Data sourced from ClinicalTrials.gov (NCT03764007). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.