F-choline PET Imaging for Cancer Detection

(F-choline Trial)

Overseen By Daniel Juneau, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Disqualifiers: Pregnancy, Breastfeeding, Allergy, Pediatric

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 3 months

500 Participants Needed

Trial Summary

What is the purpose of this trial?

Choline is an important building block of phospholipids in cell membranes. Certain cancers and medical conditions are known to demonstrate increased absorption and incorporation of choline into their cell membranes. 18-F-fluorocholine (F-choline) and 11-C-choline (C-choline) are diagnostic positron emission tomography (PET) radiotracers that can be used to image, in vivo, the metabolism of choline. Both tracers have been extensively studied in prostate cancer and C-choline has obtained US FDA approval for the investigation of recurrent prostate cancer. F-choline is currently not approved for clinical use by the FDA or Health Canada, but it offers many advantages over C-choline due to its better physical characteristics (mainly due to its positron range, shorter and longer half-life). In recent years, reports have started to emerge on broader potential applications of choline PET imaging, particularly for imaging parathyroid adenomas, certain cervical cancers and certain liver cancers. The main objective is to discover and explore potential new and emerging indications in which F-choline could play a role and provide clinically relevant information. Secondary objectives are 1) To assess the safety of F-choline PET imaging using F-choline produced at the CRCHUM; 2) assess changes in patient/disease management following F-choline PET imaging. Researchers hypothesize that F-choline will provide useful and incremental clinical information in a variety of conditions, and outperform the "standard" workup in numerous conditions. F-Choline PET exams will be performed on hybrid PET/CT scanners according to standard procedures. These examinations could be repeated at the discretion of the treating physician (up to a maximum of 4 exams per year) if the treating physician and the research team deem this could provide additional clinically useful information (for example, by helping to assess response to newly started therapy). The results will be provided to the attending physician and any new knowledge could lead to a change in treatment or an investigation of the condition that prompted enrollment in the study.

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

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the research team or your doctor.

What data supports the effectiveness of the drug F-choline for cancer detection?

Research shows that F-choline, a type of imaging drug, is useful in detecting prostate cancer and other tumors. It helps doctors see cancerous areas more clearly, especially when other imaging methods are less effective. ^{1 2 3 4 5}

Is F-choline PET imaging safe for humans?

Research on F-choline PET imaging, including variants like 18F-fluorocholine and 11C-choline, suggests it is generally safe for use in humans. These studies have primarily focused on imaging for cancer detection, particularly prostate cancer, and have not reported significant safety concerns. ^{4 6 7 8 9}

How does F-choline PET imaging differ from other cancer detection methods?

F-choline PET imaging is unique because it uses a special tracer that targets choline, a substance often increased in cancer cells, allowing for clearer images of tumors, especially in areas like the brain where other methods might struggle. This method provides high contrast images quickly, making it effective for detecting various cancers, including those that are hard to spot with standard imaging techniques. ^{1 4 5 10 11}

Research Team

Daniel Juneau, MD

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria

This trial is for adults with conditions where F-choline PET imaging might help in diagnosis or treatment decisions. It's not for pregnant or breastfeeding women, kids under 18, or anyone allergic to F-choline.

Inclusion Criteria

Any patient with a known or suspected condition in which F-choline PET imaging might provide clinically useful information.

Exclusion Criteria

I am breastfeeding and cannot stop for 48 hours.

I am allergic to F-choline or its ingredients.

You are pregnant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive F-choline PET exams to explore new and emerging indications

3 months

Up to 4 exams per year, as needed

Follow-up

Participants are monitored for safety and effectiveness after F-choline PET exams

3 months

Treatment Details

Interventions

• F-choline

Trial Overview The study tests the use of an intravenous injection of F-choline as a PET imaging agent for various medical conditions. The goal is to see if it provides better information than current methods and affects patient care.

Participant Groups

Group I: Main arm Experimental Treatment 1 Intervention

F-choline intravenous injection

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Findings from Research

This study presents the first report of using [C-11] choline PET imaging for detecting advanced colon cancer, suggesting its potential as a new tool in oncologic imaging.

The research aims to explore the effectiveness of [C-11] choline PET in identifying various tumors, including colorectal cancer, which is a significant area of interest for traditional FDG-PET imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A case of colon cancer detected by carbon-11 choline positron emission tomography/computed tomography: an initial report. Terauchi, T., Tateishi, U., Maeda, T., et al.[2016]

Choline PET/CT imaging, especially with the 18F label, is gaining attention for its potential use in diagnosing and evaluating treatment for prostate cancer, as it can highlight increased cellular membrane synthesis associated with malignancy.

Current evidence suggests that choline PET/CT may soon become a standard imaging tool in clinical settings, particularly in Europe, for assessing prostate cancer, where traditional imaging methods have limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Choline PET Tackle the Challenge of Imaging Prostate Cancer? Jadvar, H.[2021]

In a study of 250 prostate cancer patients, early F-choline PET/CT scans significantly improved the clarity of local prostate cancer lesions, with better visualization in 32 out of 57 cases compared to delayed images.

The study found that while early images enhanced the detection of local lesions, distant lesions were equally visible in both early and late scans, indicating that early imaging is particularly beneficial for assessing local disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimized protocol for (18)F-choline PET/CT in patients with biochemically relapsed prostate cancer: experiences on 250 consecutive cases. Chondrogiannis, S., Marzola, MC., Grassetto, G., et al.[2016]

(18)F-labelled choline derivatives, particularly (18)F-fluorocholine, are effective for detecting local and metastatic prostate cancer, providing a reliable single-step examination for patients with recurrent biochemical prostate cancer.

While (18)F-fluorocholine PET shows excellent discrimination between tumor and normal tissue in the brain, its utility in liver cancer detection is more challenging due to higher physiological uptake in normal liver tissue, although it remains promising for identifying hepatocellular carcinoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PET with (18)F-labelled choline-based tracers for tumour imaging: a review of the literature. Mertens, K., Slaets, D., Lambert, B., et al.[2021]

The new choline analog, [(18)F]fluoro-[1,2-(2)H(4)]choline, shows increased oxidative stability compared to the traditional [(18)F]fluorocholine, making it a promising candidate for PET imaging.

In vivo studies in tumor-bearing mice revealed that [(18)F]fluoro-[1,2-(2)H(4)]choline has significantly higher tumor uptake at later time points, suggesting it may be more effective for imaging tumor metabolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiosynthesis and pre-clinical evaluation of [(18)F]fluoro-[1,2-(2)H(4)]choline. Smith, G., Zhao, Y., Leyton, J., et al.[2022]

The new tracer (18)F-fluoroethylcholine (FECh) was successfully synthesized and showed high purity, making it a reliable option for cancer detection, particularly in prostate cancer.

Clinical studies demonstrated that (18)F-FECh PET effectively detected prostate cancer with a rapid uptake in tumors, and it provided slightly better image resolution compared to the existing (11)C-choline PET, suggesting its potential as a superior imaging tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of (18)F-fluoroethylcholine for cancer imaging with PET: synthesis, biochemistry, and prostate cancer imaging. Hara, T., Kosaka, N., Kishi, H.[2019]

The study evaluated [(18)F]fluorocholine (FCH) as a promising PET imaging probe for cancer detection, showing effective phosphorylation rates similar to choline in vitro, particularly in prostate cancer cells.

Preliminary PET imaging in patients indicated that FCH successfully highlighted cancerous tissues in prostate and breast cancers, as well as in a recurrent brain tumor, suggesting its potential as a reliable oncologic probe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synthesis and evaluation of (18)F-labeled choline analogs as oncologic PET tracers. DeGrado, TR., Baldwin, SW., Wang, S., et al.[2016]

All three variants of radiolabeled choline (11C-Choline, 18F-Methylcholine, and 18F-Ethylcholine) show minimal differences in their physiological distribution and similar diagnostic accuracy for imaging prostate cancer, based on a comprehensive literature review.

Despite their effectiveness, all choline tracers have limitations as non-tumor specific agents, which can lead to false positives, highlighting the need for standardized imaging acquisition protocols to optimize their use in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bio-Distribution, Imaging Protocols and Diagnostic Accuracy of PET with Tracers of Lipogenesis in Imaging Prostate Cancer: a Comparison between 11C-Choline, 18FFluoroethylcholine and 18F-Methylcholine. Calabria, F., Gallo, G., Schillaci, O., et al.[2019]

In a study involving 50 patients with confirmed prostate cancer, (18)F-choline PET/CT imaging effectively identified pathological uptake in the prostate, indicating its utility in evaluating the disease.

The imaging technique was able to detect metastatic spread in 44% of patients who had not undergone surgery and local recurrence in 33% of those who had, highlighting its effectiveness in both preoperative assessment and post-surgical monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of (18)F-choline PET/CT in evaluation of patients with prostate carcinoma. Hodolic, M.[2021]

Fluorocholine (FCH), a fluorine-18 labeled choline derivative, shows promise as a PET imaging agent for various cancers, including breast, prostate, liver, and brain tumors.

FCH allows for rapid whole-body imaging within minutes of injection, providing high tumor-to-background contrast, which could enhance the detection of tumors that are difficult to visualize with traditional imaging methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer imaging with fluorine-18-labeled choline derivatives. Kwee, SA., DeGrado, TR., Talbot, JN., et al.[2018]

A systematic review of 52 studies involving 1800 patients found that radiolabeled choline PET or PET/CT is effective in differentiating between high-grade and low-grade gliomas, as well as malignant and benign brain lesions, showing superior diagnostic accuracy compared to (18)F-FDG PET.

Radiolabeled choline PET or PET/CT is also useful in staging lung tumors and detecting brain metastases, and when combined with (18)F-FDG PET, it enhances detection rates for hepatocellular carcinoma, although its effectiveness in other tumor types like head and neck or gynecologic cancers remains less established.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of positron emission tomography using carbon-11 and fluorine-18 choline in tumors other than prostate cancer: a systematic review. Treglia, G., Giovannini, E., Di Franco, D., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

A case of colon cancer detected by carbon-11 choline positron emission tomography/computed tomography: an initial report. [2016]

2. Australia pubmed.ncbi.nlm.nih.gov

Can Choline PET Tackle the Challenge of Imaging Prostate Cancer? [2021]

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

Optimized protocol for (18)F-choline PET/CT in patients with biochemically relapsed prostate cancer: experiences on 250 consecutive cases. [2016]

4. Germany pubmed.ncbi.nlm.nih.gov

PET with (18)F-labelled choline-based tracers for tumour imaging: a review of the literature. [2021]

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

Radiosynthesis and pre-clinical evaluation of [(18)F]fluoro-[1,2-(2)H(4)]choline. [2022]

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

Development of (18)F-fluoroethylcholine for cancer imaging with PET: synthesis, biochemistry, and prostate cancer imaging. [2019]

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

Synthesis and evaluation of (18)F-labeled choline analogs as oncologic PET tracers. [2016]

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

Bio-Distribution, Imaging Protocols and Diagnostic Accuracy of PET with Tracers of Lipogenesis in Imaging Prostate Cancer: a Comparison between 11C-Choline, 18FFluoroethylcholine and 18F-Methylcholine. [2019]

9. Poland pubmed.ncbi.nlm.nih.gov

Role of (18)F-choline PET/CT in evaluation of patients with prostate carcinoma. [2021]

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

Cancer imaging with fluorine-18-labeled choline derivatives. [2018]

11. Japan pubmed.ncbi.nlm.nih.gov

The role of positron emission tomography using carbon-11 and fluorine-18 choline in tumors other than prostate cancer: a systematic review. [2018]