Fluorocholine PET/CT Scan for Cancer Detection

SP
Overseen ByStephan Probst, MD
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Sir Mortimer B. Davis - Jewish General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for detecting cancer using a special PET/CT scan with 18F-fluorocholine. The goal is to evaluate how effectively this scan identifies tumors that other methods might miss. Individuals with a known or suspected tumor that appears on this scan may be suitable for the trial. Participants will receive standard care and this special scan to determine if it aids doctors in diagnosing cancer more accurately. As a Phase 3 trial, this research represents the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking diagnostic advancement.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems likely that you can continue your regular medications since the study involves only a PET/CT scan.

What prior data suggests that the 18F-fluorocholine PET/CT scan is safe for cancer detection?

Research has shown that 18F-fluorocholine PET/CT scans are safe and well-tolerated for imaging. One study found this scan to be a good and safe alternative to another imaging method used in surgery. It is generally safe for patients and usually doesn't cause unpleasant side effects. As this trial is in a late phase, researchers have thoroughly studied the safety of the 18F-fluorocholine PET/CT, enhancing its reliability. So far, there have been no major reports of serious problems, which is reassuring for prospective participants.12345

Why are researchers excited about this trial?

Researchers are excited about the fluorocholine PET/CT scan because it offers a more precise way to detect cancer compared to traditional imaging methods like standard CT or MRI scans. While most imaging techniques identify tumors based on their size and shape, the fluorocholine PET/CT scan targets metabolic activity, allowing it to detect cancer cells based on their biochemical behavior. This can lead to earlier detection of cancers that might be missed with conventional scans. Additionally, the use of 18F-fluorocholine as a tracer provides clearer and more detailed images, potentially improving diagnosis and treatment planning.

What evidence suggests that 18F-fluorocholine PET/CT is effective for cancer detection?

Research has shown that 18F-fluorocholine PET/CT scans, which participants in this trial will undergo, effectively find cancerous tumors. One study showed that this imaging method correctly identified tumors 94.1% of the time, indicating high sensitivity. It also demonstrated a high positive predictive value (PPV) of 97.9%, meaning that when it detected a tumor, it was very likely cancerous. Another study demonstrated its ability to identify specific types of tumors, with a sensitivity rate of 79%. These findings suggest that 18F-fluorocholine PET/CT is a reliable tool for detecting cancer, providing clear and accurate results.678910

Who Is on the Research Team?

SP

Stephan Probst, MD

Principal Investigator

Jewish General Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Under referring physician's care
Able to understand and provide written informed consent
I can lie still for 30 minutes and handle an IV injection for a PET/CT scan.
See 1 more

Exclusion Criteria

I weigh less than 400 lbs and can fit into a 70 cm wide scanner.
You have severe claustrophobia that cannot be controlled or managed.
I am not currently experiencing any severe health crises like heart or breathing problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Administration of 18F-fluorocholine followed by a PET/CT scan

1 day
1 visit (in-person)

Follow-up

Participants are monitored for diagnostic accuracy and adverse events

30 minutes
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • 18F-fluorocholine PET/CT
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Fluorocholine PET/CTExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sir Mortimer B. Davis - Jewish General Hospital

Lead Sponsor

Trials
61
Recruited
25,800+

Published Research Related to This Trial

The study of 18F-Fluorocholine (FCH) shows that it has rapid pharmacokinetics in both mice and humans, with biodistribution stabilizing after just 10 minutes, making it a promising oncologic probe for PET imaging.
The kidneys are identified as the dose-critical organ for 18F-FCH, which limits the safe administration level to 4.07 MBq/kg (0.110 mCi/kg) in human studies, ensuring patient safety during imaging procedures.
Pharmacokinetics and radiation dosimetry of 18F-fluorocholine.DeGrado, TR., Reiman, RE., Price, DT., et al.[2022]

Citations

Performance of F-18 Fluorocholine PET/CT for Detection ...Even in this difficult population, FCH PET/CT presented impressive results with high sensitivity, PPV, and accuracy of 94.1%, 97.9%, and 92.4%, respectively, ...
Contribution of 18 F-fluorocholine PET-CT to the ...18 F-fluorocholine PET-CT has favourable diagnostic characteristics in patients with multigland disease, with good sensitivity (79% for lesion- ...
Detection of recurrence sites using 18F-fluorocholine PET ...FCH-PET/CT demonstrated a 59.6% overall detection rate, and the optimal PSA threshold for detecting positive findings was ≥ 1.00 ng/mL at the time of imaging.
Comparative effectiveness of [18F]-Fluorocholine PET-CT and ...In a patient-based analysis sensitivity and specificity were 78% and 94% for 18F-Choline and 33% and 91% for DWI MRI respectively. Out of the 222 prostate ...
18F-fluorocholine PET/CT in patients with occult biochemical ...FCH PET/CT had no clinical impact in 79 patients (45%), 31 with positive, 13 with equivocal and 35 with negative FCH PET/CT. Of the 31 patients with positive ...
NCT04150458 | Fluorocholine PET/CT Basket TrialDiagnostic accuracy of 18F-fluorocholine PET/CT will be captured versus a composite clinical, radiological and histopathological standard of truth at follow-up.
7.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/39306520/
18F-Fluorocholine-Positron Emission Tomography ...FCH PET/CT as the first-line radionuclide imaging technique in patients with all types of HPT in whom surgery is an option.
18F-Fluorocholine PET/CT in Primary Hyperparathyroidism ...18 F-fluorocholine PET/CT is a diagnostic modality superior to conventional imaging methods in patients with PHPT, allowing for accurate preoperative ...
18F-Fluorocholine-Positron Emission Tomography ...FCH PET/CT as the first-line radionuclide imaging technique in patients with all types of HPT in whom surgery is an option.
F18-Choline PET/CT or MIBI SPECT/CT in the Surgical ...Conclusions This randomized clinical trial found that first-line FCH PET/CT is a suitable and safe replacement for MIBI SPECT/CT. FCH PET/CT ...
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