18F-Fluorocholine for the Detection of Parathyroid Adenomas

Phase 2

Completed

• Conditions: Hyperparathyroidism, Primary
• Interventions: Drug: 18F-Fluorocholine; Procedure: Positron Emission Tomography (PET)

• Registration Number: NCT03764007
• Lead Sponsor: Thomas Hope

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-21
• Study First Submitted: 2018-11-30
• Study First Submitted QC: 2018-12-03
• Study First Posted: 2018-12-04
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Status Verified: 2021-08
• Results First Submitted: 2021-08-25
• Results First Submitted QC: 2021-09-21
• Last Update Submitted: 2021-09-21
• Results First Posted: 2021-10-19
• Last Update Posted: 2021-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
18F-Fluorocholine PET	Positron Emission Tomography (PET)	Patients will undergo a single fluorocholine PET imaging study prior to surgery.
18F-Fluorocholine PET	18F-Fluorocholine	Patients will undergo a single fluorocholine PET imaging study prior to surgery.

Primary Outcome Measures

Name	Time	Method
Proportion of True Positives for the Detection of the Abnormal Parathyroid Adenoma Using Sestamibi Imaging	Up to 1 year	The true positive (sensitivity) rate is defined as the proportion of participants with location of the suspected adenoma on 18F-Fluorocholine PET correlating with location of an abnormal parathyroid at time of participant surgery. For a patient with multiple hyperplastic glands, only one gland needs to correlate for the patient to count as a true positive. In patients who had a sestamibi study performed prior to the fluorocholine imaging study, the original dictated report from the sestamibi will be used for comparison. For analysis, adenomas described as arising in the mid thyroid bed will considered correct if located in either the inferior or superior bed. Patients will be followed-up to determine if they undergo a parathyroidectomy for up to 1 year.
Proportion of True Positives for the Overall Detection of the Abnormal Parathyroid Adenoma	Up to 1 year	The true positive (sensitivity) rate is defined as the proportion of participants with location of the suspected adenoma on 18F-Fluorocholine PET correlating with location of an abnormal parathyroid at time of participant surgery. For a patient with multiple hyperplastic glands, only one gland needs to correlate for the patient to count as a true positive. For analysis, adenomas described as arising in the mid thyroid bed will considered correct if located in either the inferior or superior bed. Patients will be followed-up to determine if they undergo a parathyroidectomy for up to 1 year.

Secondary Outcome Measures

Name	Time	Method
Detection Rate in Patients Who Have Not Undergone Surgical Resection	Up to 1 year	The detection rate is defined as the proportion of participants with a 18F-fluorocholine PET positive read who do not subsequently undergo parathyroidectomy, using the dictated reports to determine the detection sensitivity for parathyroid adenomas. Patients will be followed-up to determine if they undergo a parathyroidectomy for up to 1 year.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States