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Fluorocholine PET/CT Scan for Cancer Detection

Phase 3
Waitlist Available
Led By Stephan Probst, MD
Research Sponsored by Sir Mortimer B. Davis - Jewish General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 years or older
Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine (or prone) for up to 30 minutes and tolerating intravenous cannulation for injection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes
Awards & highlights

Study Summary

This trial will study if a PET/CT scan can accurately detect benign/malignant tumors. Patients will receive a scan with a radioactive material & be monitored to see how accurate the scan is.

Who is the study for?
This trial is for adults over 18 with known or suspected tumors that may take up a substance called 18F-fluorocholine, according to medical literature. Participants must be able to lie still for the scan and handle an IV injection. It's not suitable for medically unstable individuals, those too large for the PET/CT equipment, or those with severe claustrophobia.Check my eligibility
What is being tested?
The trial tests how well a special type of imaging called an 18F-fluorocholine PET/CT scan can identify benign or malignant tumors compared to other clinical assessments. Up to 2000 patients will receive this scan in addition to their regular care.See study design
What are the potential side effects?
Potential side effects from the intervention are minimal but may include discomfort from lying still during the scan, reactions at the IV site where fluorocholine is injected, and anxiety due to confinement within the PET/CT scanner.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I can lie still for 30 minutes and handle an IV injection for a PET/CT scan.
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My tumor is likely to show up on a specific PET scan.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Diagnostic accuracy of Fluorocholine PET/CT
Secondary outcome measures
Incidence of treatment-emergent adverse events following Fluorocholine PET/CT

Side effects data

From 2014 Phase 4 trial • 60 Patients • NCT01749982
13%
Diarrhea
13%
Fever
7%
Chest pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Choline Bitartrate
Betaine
Choline Bitartrate + Betaine

Trial Design

1Treatment groups
Experimental Treatment
Group I: Fluorocholine PET/CTExperimental Treatment1 Intervention
The sole study-specific procedure is a single 18F-fluorocholine positron emission tomography / computed tomography (PET/CT). Subjects will receive 9 mCi 18F-fluorocholine IV, 5 to 120 minutes prior to PET/CT. 18F-fluorocholine PET/CT studies will be performed on hybrid PET/CT scanners which combine a dedicated, full-ring PET scanner with a multi-slice spiral CT scanner.

Find a Location

Who is running the clinical trial?

Sir Mortimer B. Davis - Jewish General HospitalLead Sponsor
55 Previous Clinical Trials
19,160 Total Patients Enrolled
Stephan Probst, MDPrincipal InvestigatorJewish General Hospital
1 Previous Clinical Trials
11 Total Patients Enrolled

Media Library

Fluorocholine PET/CT Clinical Trial Eligibility Overview. Trial Name: NCT04150458 — Phase 3
Fluorocholine PET/CT Research Study Groups: Fluorocholine PET/CT
Fluorocholine PET/CT Clinical Trial 2023: Fluorocholine PET/CT Highlights & Side Effects. Trial Name: NCT04150458 — Phase 3
Fluorocholine PET/CT 2023 Treatment Timeline for Medical Study. Trial Name: NCT04150458 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA given its stamp of approval to Fluorocholine PET/CT?

"The safety of Fluorocholine PET/CT was rated a 3 due to the abundance of data backing its efficacy and multiple trials vouching for its protection."

Answered by AI

Are applicants aged 85 and under eligible for this research?

"This clinical investigation stipulates that patients must be between the age of 18 and 110 to qualify. Separate studies are available for those under 18 and over 65, totalling seven in number."

Answered by AI

Who is eligible to partake in this medical research?

"For eligibility in this study, participants must meet the age requirement of being between 18 and 110 years old. Additionally, they should have had a fluorocholine pet/ct scan. The team is looking for approximately 2000 people to join the trial."

Answered by AI

Are there still openings for potential participants in this research endeavor?

"At present, this clinical trial is not actively enrolling patients. Initially posted on November 30th 2022 and most recently updated on April 10th 2023, those looking to join a medical study may find success with the one trial seeking participants for fluorocholine PET/CT or any of the seven studies that use Fluorocholine PET/CT as an intervention."

Answered by AI

Can you tell me the upper limit for participants in this clinical research?

"At this point in time, the trial is not taking on new participants. It was initially published to clinicaltrials.gov on November 30th 2022 and its most recent edit occurred April 10th 2023. If you are searching for alternatives, there are presently 1 study recruiting patients with fluorocholine PET/CT and 7 trials admitting individuals for Fluorocholine PET/CT therapy."

Answered by AI

To what degree has Fluorocholine PET/CT been studied in prior research studies?

"Presently, there are 7 studies assessing the efficacy of Fluorocholine PET/CT. 2 of these active trials have progressed to Phase 3 testing. Montréal is home to multiple clinical trial sites, but other locations in Quebec also host investigations into this treatment modality."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Fluorocholine PET/CT Basket Trial
Stephan Probst, MD 2022. "Fluorocholine PET/CT Basket Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04150458.
~1333 spots leftby Jan 2030
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