Recruiting
Phase 3

Choline-PET

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT04999215

Conditions

Lesion With Known or Suspected F-choline Uptake

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

F-choline intravenous injection

Study Details

Brief 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

Study ID

NCT04999215

Start date

Aug 1, 2022

Status verified date

Mar, 2026

Completion date

Aug 1, 2032

Anticipated

Primary completion date

Jul 1, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

500 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Main arm

F-choline intravenous injection

Interventions

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.

Primary outcome measure

  • Diagnostic performance (sensitivity and specificity) of F-choline PET/CT [ Time Frame: 3 months ]
  • Adverse reaction to the F-choline injection [ Time Frame: 24 hours ]

Central Contacts and Locations

Central contacts

Daniel Juneau, MD

1-514-890-8180daniel.juneau@umontreal.ca

Locations

Centre Hospitalier de l'université de Montréal

Recruiting

Montreal, Quebec, Canada, H2X 0C1

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Mar 19, 2026

Last verified

Mar, 2026

Keywords

  • Imaging
  • F-choline PET
  • Diagnostic performance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2026-03-19.