Choline-PET: Exploratory Study Assessing the Potential Role of F-choline PET Imaging in New and Emerging Indications (F-choline)

Choline is an important building block of phospholipids in cell membranes. Certain cancers and medical conditions are known to demonstrate increased absorption and incorporation of choline into their cell membranes. 18-F-fluorocholine (F-choline) and 11-C-choline (C-choline) are diagnostic positron emission tomography (PET) radiotracers that can be used to image, in vivo, the metabolism of choline. Both tracers have been extensively studied in prostate cancer and C-choline has obtained US FDA approval for the investigation of recurrent prostate cancer. F-choline is currently not approved for clinical use by the FDA or Health Canada, but it offers many advantages over C-choline due to its better physical characteristics (mainly due to its positron range, shorter and longer half-life). In recent years, reports have started to emerge on broader potential applications of choline PET imaging, particularly for imaging parathyroid adenomas, certain cervical cancers and certain liver cancers.

The main objective is to discover and explore potential new and emerging indications in which F-choline could play a role and provide clinically relevant information.

Secondary objectives are 1) To assess the safety of F-choline PET imaging using F-choline produced at the CRCHUM; 2) assess changes in patient/disease management following F-choline PET imaging.

Researchers hypothesize that F-choline will provide useful and incremental clinical information in a variety of conditions, and outperform the "standard" workup in numerous conditions.

F-Choline PET exams will be performed on hybrid PET/CT scanners according to standard procedures. These examinations could be repeated at the discretion of the treating physician (up to a maximum of 4 exams per year) if the treating physician and the research team deem this could provide additional clinically useful information (for example, by helping to assess response to newly started therapy).

The results will be provided to the attending physician and any new knowledge could lead to a change in treatment or an investigation of the condition that prompted enrollment in the study.

Study Overview

• Status: Recruiting
• Conditions: Lesion With Known or Suspected F-choline Uptake
• Intervention / Treatment: Drug: F-choline intravenous injection

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Daniel Juneau, MD; Phone Number: 1-514-890-8180; Email: daniel.juneau@umontreal.ca

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2X 0C1
      • Recruiting
      • Centre Hospitalier de l'Université de Montréal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Any patient with a known or suspected condition in which F-choline PET imaging might provide clinically useful information.

Exclusion Criteria:

• Pregnancy
• Breastfeeding woman, unwilling to discontinue breastfeeding for 48 hours
• Known allergy to F-choline or any excipients
• Pediatric patient (< 18 years old)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Main arm; F-choline intravenous injection	Drug: F-choline intravenous injection; Participants will receive one injection of F-choline before undergoing hybrid PET/CT imaging per standard procedures. F-choline PET examinations may be repeated, if this judged to be in the patient's best interest by his referring physician and the study staff, up to a maximum 4 examinations per year.; Other Names: Fluorocholine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic performance (sensitivity and specificity) of F-choline PET/CT	"Gold-standard" will be a composite of other imaging modalities, pathological data when available, and clinical follow-up.	3 months
Adverse reaction to the F-choline injection	Absence or presence of adverse reactions related to F-choline injection (yes or no)	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in management following F-choline PET/CT	Frequency of change in management, comparing planned management before and after F-choline PET/CT	3 months

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Investigators: Principal Investigator: Daniel Juneau, MD, Centre Hospitalier de l'Universite de Montreal (CHUM)

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): July 1, 2032
• Study Completion (Estimated): August 1, 2032

Study Registration Dates

• First Submitted: August 5, 2021
• First Submitted That Met QC Criteria: August 5, 2021
• First Posted (Actual): August 10, 2021

Study Record Updates

• Last Update Posted (Estimated): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Imaging; F-choline PET; Diagnostic performance
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antimetabolites; Gastrointestinal Agents; Hypolipidemic Agents; Lipid Regulating Agents; Nootropic Agents; Lipotropic Agents; Choline
• Other Study ID Numbers: 2021-9489

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No