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

Must not have

Exceeding the safe weight limit of the PET/CT bed (usually approximately 400 lbs.) or cannot fit through the PET/CT bore (usually approximately 70 cm diameter)

Medically unstable (e.g. acute cardiac or respiratory distress or hypotensive)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 minutes

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial involves giving patients an imaging agent called 18F-fluorocholine and then performing a PET/CT scan. It targets patients with tumors that are expected to absorb this agent. The goal is to see how well this method helps in detecting tumors by making them light up during the scan. 18F-fluorocholine has been developed as an oncologic probe for PET and is particularly promising for imaging tumor cell proliferation in prostate cancer.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I weigh less than 400 lbs and can fit into a 70 cm wide scanner.

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I am not currently experiencing any severe health crises like heart or breathing problems.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Diagnostic accuracy of Fluorocholine PET/CT

Secondary study objectives

Incidence of treatment-emergent adverse events following Fluorocholine PET/CT

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 / 5Eligibility 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.