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

NCT04999215 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2026-03-19

No results posted yet for this study

Summary

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.

Conditions

  • Lesion With Known or Suspected F-choline Uptake

Interventions

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.

Sponsors & Collaborators

  • Centre hospitalier de l'Université de Montréal (CHUM)

    lead OTHER

Principal Investigators

  • Daniel Juneau, MD · Centre hospitalier de l'Université de Montréal (CHUM)

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2032-07-01
Completion
2032-08-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04999215 on ClinicalTrials.gov