F-choline PET Imaging for Cancer Detection

(F-choline Trial)

Recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging tool called F-choline PET, which helps doctors see how certain cancers and conditions absorb choline. The goal is to determine if F-choline provides more useful information than current methods, particularly for conditions like parathyroid adenomas or certain cervical and liver cancers. The trial will also assess the safety of F-choline and its potential to change how doctors manage these conditions. This trial might suit patients with conditions where F-choline PET imaging could help their doctor better understand their illness. As a Phase 3 trial, it represents the final step before FDA approval, offering patients a chance to contribute to a potentially groundbreaking advancement in medical imaging.

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 prior data suggests that F-choline PET imaging is safe?

Research on F-choline PET imaging suggests it is generally safe for humans. Studies have shown that F-choline is well-tolerated by patients and has been tested in many people, particularly those with prostate cancer. Serious side effects are not commonly reported with F-choline.

The FDA has already approved C-choline, a similar substance, for detecting prostate cancer recurrence. This approval supports the idea that F-choline, which is quite similar, could also be safe. Some studies indicate that F-choline has better physical properties, potentially making it safer or more effective.

Overall, evidence suggests that F-choline PET imaging is a safe option for detecting cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about F-choline PET imaging because it offers a novel way to detect cancer by using F-choline as a tracer in PET scans. Traditional imaging methods often rely on glucose-based tracers, which can sometimes miss certain types of cancer cells. F-choline targets the choline uptake pathway, which is more active in many cancer cells, potentially allowing for more precise detection. This method could lead to earlier and more accurate diagnoses, improving treatment planning and outcomes for patients.

What evidence suggests that F-choline PET imaging is effective for cancer detection?

Research has shown that F-choline PET imaging, which participants in this trial will receive, holds promise, particularly for detecting prostate cancer. One study found that F-choline offers better accuracy in diagnosing prostate cancer than other imaging methods. Another study demonstrated that F-choline PET/CT more effectively identifies cancer spread to lymph nodes and bones compared to traditional imaging. F-choline can detect cancer spread more accurately, potentially leading to better treatment choices. Although not yet approved for use, its potential in cancer detection is gaining attention. ^{2 4 6 7 8}

Who Is on the Research Team?

Daniel Juneau, MD

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

(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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8249319/

The Diagnostic Role of 18F-Choline, 18F-Fluciclovine and ... These three 18 F-labeled tracers are promising for detecting BCR in prostate cancer patients, with 18 F-choline showing superior diagnostic accuracy.

2. jnm.snmjournals.org jnm.snmjournals.org/content/65/7/1013

A Prospective Randomized Multicenter Study on the Impact of ... [18F]F-choline PET/CT has demonstrated higher diagnostic performance than conventional imaging in detecting both lymph node and bone metastases.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2253808922001112

Effectiveness of 11C-choline PET/CT in prostate cancer ... 11 C-choline PET/CT demonstrated its effectiveness in PCa surveillance and restaging, even in patients with serum PSA < 1 ng/mL.

4. ajronline.org ajronline.org/doi/10.2214/AJR.17.18567

18F-Fluorocholine PET Whole-Body MRI in the Staging of ... There was a trend toward improved detection with PET/WBMRI (77/77 [100%]) compared with PET alone (p = 0.059). For correct NM staging, PET and PET/WBMRI ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31350321/

18F-Choline PET/mpMRI for Detection of Clinically Significant ... The objective of this study was to evaluate the cost-effectiveness of 18 F-choline PET/multiparametric MRI (mpMRI) versus mpMRI alone for the detection of ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2012/203155orig1s000medr.pdf

203155Orig1s000 - accessdata.fda.gov [18F]fluorocholine PET/CT imaging for the detection of recurrent prostate cancer at ... Kinetics of [(11)C]choline uptake in prostate cancer: a ...

7. withpower.com withpower.com/trial/phase-3-8-2021-daef8

F-choline PET Imaging for Cancer Detection 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 ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0001299824000758

18F-Fluorocholine-Positron Emission Tomography ... Safety Profile of FCH, Dosimetry and Use in Special Populations · Interpreting and Reporting FCH PET/CT.