Fluciclovine PET/CT for Muscle-Invasive Bladder Cancer

Overseen By Heather Jacene, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Other malignancies, Pregnant, Breastfeeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for scanning muscle-invasive bladder cancer using a special PET scan with a radioactive agent called 18F-fluciclovine (also known as 18F-FACBC or Axumin). The aim is to determine if this scan can better reveal the extent of the cancer and provide more detailed information about the tumor compared to regular CT or MRI scans. It suits individuals diagnosed with bladder cancer who have specific tumor characteristics and plan to undergo bladder removal surgery. Participants should not have any other recent cancers or conditions that might interfere with the trial. As an Early Phase 1 trial, this research focuses on understanding how this new scanning method works in people, offering participants a chance to contribute to groundbreaking advancements in cancer imaging.

Do I need to stop my current medications to join the trial?

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

What prior data suggests that 18F-fluciclovine is safe for use in PET/CT scans?

Research has shown that 18F-fluciclovine is generally safe for people, with no known contraindications, making it suitable for most conditions. Studies indicate it is equally safe for both older and younger adults.

Additionally, the FDA has approved 18F-fluciclovine for detecting recurrent prostate cancer. While it does not treat cancer, it helps doctors obtain clear images, aiding in treatment planning. This approval suggests safety, but discussing any concerns with a healthcare provider before joining a trial is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using 18F-fluciclovine for muscle-invasive bladder cancer because it offers a new way to visualize the disease. Unlike traditional imaging techniques, which may not always clearly differentiate cancerous tissue, 18F-fluciclovine is a radiopharmaceutical that highlights cancer cells more distinctly during PET/CT scans. This enhanced imaging could lead to better treatment planning and more precise targeting of therapy. Additionally, the quick administration and rapid imaging process could streamline patient workflow, making it a promising option for improving diagnostic accuracy in bladder cancer management.

What evidence suggests that 18F-fluciclovine PET/CT is effective for evaluating muscle-invasive bladder cancer?

Research has shown that 18F-fluciclovine, which participants in this trial will receive, aids in imaging certain cancers. One study found it useful for assessing the stage of muscle-invasive bladder cancer, offering doctors a clearer view before surgery. Other research indicates that it does not mix significantly with urine, preventing the bladder from obstructing the scan. This might offer a better view of the tumor compared to other imaging methods. Overall, 18F-fluciclovine could provide more accurate details about the cancer's size and severity. ^{3 6 7 8 9}

Who Is on the Research Team?

Heather Jacene, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 with muscle invasive bladder cancer, who are planning to have their bladder removed (radical cystectomy). They must not be pregnant or breastfeeding, agree to use contraception, and should not have other cancers treated in the last 3 years. Severe claustrophobia or serious illnesses that could interfere with the study are also reasons for exclusion.

Inclusion Criteria

I am scheduled for a major bladder surgery after a specific PET/CT scan.

I may or may not have had treatment to shrink my tumor before surgery.

I can care for myself but may not be able to do active work.

Exclusion Criteria

I have had cancer that needed treatment in the last 3 years.

You have a strong fear of being in small, enclosed spaces.

You have had allergic reactions to similar drugs as 18F-fluciclovine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

18F-fluciclovine is administered and dynamic PET/CT images of the pelvis are obtained, followed by PET/CT images from the pelvis to the base of the skull

1 day

1 visit (in-person)

Surgery

Radical cystectomy is performed to obtain pathology specimens for comparison with PET/CT results

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging and surgery

2 years

What Are the Treatments Tested in This Trial?

Interventions

• 18F-fluciclovine

Trial Overview The study tests a PET scan agent called 18F-fluciclovine against standard CT/MRI scans to see if it's better at showing how far bladder cancer has spread and determining tumor grade before surgery.

How Is the Trial Designed?

Group I: 18F-fluciclovine Experimental Treatment 2 Interventions

* 18F-fluciclovine will be administered via slow push over 10 seconds through a peripheral intravenous line * Immediately after the injection of the radiopharmaceutical, dynamic PET/CT images of the pelvis will be obtained for 15 minutes * Subsequently, PET/CT images will be obtained from the pelvis to the base of skull.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Blue Earth Diagnostics

Industry Sponsor

Trials

43

Recruited

3,100+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6910635/

Update on 18F-Fluciclovine PET for Prostate Cancer Imaging Early 18F-fluciclovine biodistribution studies demonstrated relatively low urinary excretion, with urinary bladder doses ranging from 12 to 25 ...

2. researchgate.net researchgate.net/publication/390978412_A_pilot_study_of_FF-fluciclovine_positron_emission_tomographycomputed_tomography_for_staging_muscle_invasive_bladder_cancer_preceding_radical_cystectomy

A pilot study of [F]F-fluciclovine positron emission ... Aim To assess the ability of [¹⁸F]F-fluciclovine-PET/CT to stage muscle invasive bladder cancer (MIBC) before radical cystectomy. Methods This ...

3. redjournal.org redjournal.org/article/S0360-3016(20)31977-5/pdf

Advanced Imaging Including the 18-F Fluciclovine PET-CT ... Conclusion: These data demonstrate high rate of LC and bladder pres- ervation in MIBC patients undergoing definitive CMT in the modern IM-. IGRT era. It also ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8037300/

The Role of [18F]Fluciclovine PET/CT in the Characterization ... Comparison of [ 18 F]Fluciclovine vs. [ 11 C]Choline PET/CT performance for high-grade malignant lesions (pISUP 4–5) detection, using semi-quantitative ...

5. jnm.snmjournals.org jnm.snmjournals.org/content/61/supplement_1/357

18F-Fluciclovine PET/CT Use in the Evaluation of Endometrial ... Bladder excretion of 18F-fluciclovine is minimal, which potentially allows a higher tumor-to-background ratio in patients with endometrial ...

6. axumin.com axumin.com/about/safety-side-effects

Axumin® (fluciclovine F 18) injection | Safety & Side Effects Axumin has no contraindications. No overall differences in safety or effectiveness were observed between older adults and younger subjects.

7. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04018053?term=amino+acid+transporter&draw=2&rank=4

18Fluorine-Fluciclovine PET/CT for Staging Muscle ... Since no dosing or adverse event data are currently available on the use of 18F-fluciclovine in participants <18 years of age, and the majority of bladder ...

8. bcan.org bcan.org/clinicaltrials/18fluorine-fluciclovine-pet-ct-for-staging-muscle-invasive-bladder-cancer-preceding-radical-cystectomy/

Clinical Trial Staging MIBC Preceding Radical Cystectomy This research studies 18F-fluciclovine to evaluate how well 18F-fluciclovine-PET scans determine the extent of muscle invasive bladder cancer.

9. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2019-07757

18Fluorine-Fluciclovine Positron Emission Tomography/ ... 18F-fluciclovine does not treat cancer; it only allows physicians to take images (pictures) of it. Staging of muscle invasive bladder cancer is currently done ...