18F-Fluorocholine for the Detection of Parathyroid Adenomas

NCT03764007 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 16-19297
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hyperparathyroidism, Primary

Keywords

Positron emission tomography

Outcome Measures

Primary Outcomes (2)

• Proportion of True Positives for the Overall Detection of the Abnormal Parathyroid Adenoma

  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.

  Up to 1 year

• Proportion of True Positives for the Detection of the Abnormal Parathyroid Adenoma Using Sestamibi Imaging

  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.

  Up to 1 year

Secondary Outcomes (1)

• Detection Rate in Patients Who Have Not Undergone Surgical Resection

  Up to 1 year

Study Arms (1)

18F-Fluorocholine PET

EXPERIMENTAL

Patients will undergo a single fluorocholine PET imaging study prior to surgery.

Drug: 18F-Fluorocholine; Procedure: Positron Emission Tomography (PET)

Interventions

18F-Fluorocholine DRUG

Given intravenously

Also known as: Fluorocholine

18F-Fluorocholine PET

Positron Emission Tomography (PET) PROCEDURE

Imaging technique that uses radioactive agents known as radiotracers to visualize and measure changes in metabolic processes, and in other physiological activities

Also known as: PET

18F-Fluorocholine PET

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thomas Hope: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Links

• Journal of Nuclear Medicine, published on March 5, 2021 as doi:10.2967/jnumed.120.256735

MeSH Terms

Conditions

Hyperparathyroidism, Primary

Interventions

fluorocholine; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Dr. Thomas A. Hope, MD
• Organization: University of California, San Francisco

Thomas.Hope@ucsf.edu

(415) 221-4810

Study Officials

• Thomas Hope, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Radiology

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 4, 2018
• Study Start: September 21, 2016
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: October 19, 2021
• Results First Posted: October 19, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)