What side effects are associated with this type of intervention?

Common side effects of diagnostic imaging agents like gadolinium-based contrast agents, which may be similar to those of 18F-fluorocholine used in PET/CT scans, include mild reactions such as nausea, headache, dizziness, and injection site reactions. Severe reactions are rare but can include allergic reactions, nephrogenic systemic fibrosis in patients with severe renal dysfunction, and delayed hypersensitivity reactions.

What prior FDA approvals exist?

The FDA has approved various diagnostic imaging agents for PET/CT scans, such as 18F-FDG (fluorodeoxyglucose), which is widely used for detecting and monitoring various types of cancers. While the specific approval status of 18F-fluorocholine is not detailed, it is used in clinical trials to evaluate its diagnostic accuracy for detecting benign or malignant tumors. Similar agents like 18F-FDG have set a precedent for the use of radiotracers in PET/CT imaging to improve cancer diagnosis and management.

What other types of research exist?

Promising novel alternatives to 18F-fluorocholine for PET/CT scans include Ga-68 PSMA-11 and piflufolastat F-18. Ga-68 PSMA-11 is approved for PSMA-targeted PET imaging in prostate cancer patients, including those with suspected recurrence based on elevated PSA levels. Piflufolastat F-18 is also approved for PSMA-targeted PET imaging in males with suspected recurrence or metastases. Both agents offer high sensitivity and specificity for detecting prostate cancer lesions, potentially improving diagnostic accuracy and patient outcomes.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 minutes

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

Chest pain

100%

80%

60%

40%

20%

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.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Fluorocholine PET/CT utilizes 18F-fluorocholine, a radiolabeled choline analog, which is preferentially taken up by cells with high lipid metabolism, such as cancer cells. Once inside the cell, 18F-fluorocholine is phosphorylated and incorporated into the cell membrane, allowing for precise imaging of tumors. This mechanism is crucial for patients as it enhances the detection and localization of malignant tumors, leading to more accurate diagnosis and better-informed treatment decisions.

[18F]-Fluciclovine PET/CT for preoperative nodal staging in high-risk primary prostate cancer: final results of a prospective trial.Histopathological correlation of (11)C-choline PET scans for target volume definition in radical prostate radiotherapy.