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Recruiting NCT04999215

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

Phase III Interventional Lesion With Known or Suspected F-choline Uptake

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: F-choline intravenous injection.
Who it may be relevant to
Registry conditions: Lesion With Known or Suspected F-choline Uptake. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • Change in management following F-choline PET/CT [Time frame: 3 months]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Canada · 1 center
  • Centre Hospitalier de l'université de Montréal — Montreal

Identifiers

NCT: NCT04999215 · 21.177

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗