Fluorocholine PET/CT Scan for Cancer Detection

Overseen By Stephan Probst, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Sir Mortimer B. Davis - Jewish General Hospital

Disqualifiers: Medically unstable, Weight limit, Claustrophobia

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

2000 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment 18F-fluorocholine PET/CT for cancer detection?

Research shows that 18F-fluorocholine PET/CT is effective in detecting early bone marrow metastases in prostate cancer and can help differentiate between cancerous and non-cancerous bone changes. It is also useful in identifying tumor recurrence in glioma, increasing the confidence of MRI results. ^{1 2 3 4 5}

Is 18F-fluorocholine PET/CT generally safe for humans?

Research on 18F-fluorocholine PET/CT, used for cancer detection, shows it is prepared with high purity and no harmful chemical contamination, suggesting it is safe for human use. ^{4 6 7 8 9}

How is the 18F-fluorocholine PET/CT scan different from other cancer detection methods?

The 18F-fluorocholine PET/CT scan is unique because it uses a special imaging agent that helps detect cancer by highlighting areas of increased cell activity, which is particularly useful for early detection of tumor recurrence and bone metastases. Unlike other imaging methods, it provides greater specificity in distinguishing between malignant and non-malignant bone changes, making it especially valuable in prostate cancer diagnosis. ^{1 2 6 10 11}

What is the purpose of this trial?

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.

Research Team

Stephan Probst, MD

Principal Investigator

Jewish General Hospital

Eligibility Criteria

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.

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

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)

Treatment Details

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.

Participant Groups

Group I: Fluorocholine PET/CT Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Sir Mortimer B. Davis - Jewish General Hospital

Lead Sponsor

Trials

61

Recruited

25,800+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and radiation dosimetry of 18F-fluorocholine. DeGrado, TR., Reiman, RE., Price, DT., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Early Recurrence Detection of Glioma Using 18 F-Fluorocholine PET/CT : GliReDe Pilot Study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Prostate Cancer Bone Metastases with 18F-NaF and 18F-Fluorocholine PET/CT. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Clinical utility of (18)F-fluorocholine positron-emission tomography/computed tomography (PET/CT) in biochemical relapse of prostate cancer after radical treatment: results of a multicentre study. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

"Real-world" evaluation of 18F-Choline PET/CT practices in prostate cancer patients and impact on changes in therapeutic strategy. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Potential of hybrid ¹⁸F-fluorocholine PET/MRI for prostate cancer imaging. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and radiation dosimetry of 18F-fluorocholine. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Significance of 18F-fluorocholine PET/CT positive pulmonary lesions in prostate cancer patients. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Simplified fast and high yielding automated synthesis of [18F]fluoroethylcholine for prostate cancer imaging. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

Feasibility of 18F-fluoromethylcholine PET/CT for imaging of vessel wall alterations in humans--first results. [2018]

10. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Optimising the Azeotropic Drying of 18F-Fluorine Wayto Improve the 18F-Fluorocholine Radiochemical Yield. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Osteoblastic bone metastases from neuroendocrine tumor (NET) of unknown origin detected by 18fluorocholine PET/CT and its comparison with 68gallium-DOTATOC PET/CT: Case report and review of the literature. [2023]