Phase 3 Completed N=98 Diagnostic

18F-Fluorocholine for the Detection of Parathyroid Adenomas

Hyperparathyroidism, Primary

Source: ClinicalTrials.gov NCT03764007 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2021

Primary outcomePrimary: Proportion of True Positives for the Overall Detection of the Abnormal Parathyroid Adenoma — 0.75 proportion of participants

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

Summary

The investigators are studying the ability of F18 labeled fluorocholine PET to localize parathyroid adenomas in patients with hyperparathyroidism prior to surgery.

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	—

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.

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.