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

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

16 Participants Needed

Trial Summary

What is the purpose of this trial?

This research study is studying a positron emission tomography (PET) agent called 18F-fluciclovine to evaluate how well 18F-fluciclovine-PET scans determine the extent of muscle invasive bladder cancer (as compared to regular CT and MRI imaging) and whether 18F-fluciclovine-PET scans can provide information about the pathologic grade of the tumor.

Research Team

Heather Jacene, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+