Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04999215 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: F-choline
StatusRecruiting
PhasePhase 3
Started2022-08-01
View on ClinicalTrials.gov ↗

Amendment history

2026-03-17
minor
3 amendments v6-v8
3 re-verifications since 2023-06-12, no change to tracked fields
2022-12-06
notable
Active, Not Recruiting→Recruiting Study Status, Arms and Interventions, Outcome Measures, Contacts/Locations v5
Trial statusActive, Not Recruiting→Recruiting
Secondary endpointsdetails revised at 1 of 1 entry
Study sitesdetails revised at 1 of 1 site
2022-11-10
minor
Study Status v4
Start date2022-07-01→2022-08-01
2022-07-26
notable
Not Yet Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Active, Not Recruiting
Primary completion date2032-03-01→2032-07-01
Completion date2032-03-01→2032-08-01
Start dateestimated 2022-03-01→confirmed 2022-07-01
Study sites0→1
2021-11-02
minor
Study Status v2
Primary completion date2031-09-01→2032-03-01
Completion date2031-09-01→2032-03-01
Start date2021-09-01→2022-03-01
2021-08-10
minor
Study Status, Conditions, Outcome Measures v1
Secondary endpoints2 to 1 entries
Incidence of specific adverse reactions related to F-choline injection
Primary endpoints2 entries, revised
Diagnostic performance (sensitivity and specificity) of F-choline PET/CT
2021-08-05
minor
Original filing
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.
Trial Details
NCT Number NCT04999215
Lead Sponsor Centre hospitalier de l'Université de Montréal (CHUM)
Conditions Lesion With Known or Suspected F-choline Uptake
Enrollment 500 participants
Start Date 2022-08-01
Primary Completion 2032-07-01 (estimated)
Study Completion 2032-08-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-19