Fluciclovine PET/CT for Muscle-Invasive Bladder Cancer

Recruiting in Palo Alto (17 mi)

Overseen byHeather Jacene, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Approved in 1 Jurisdiction

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.

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.

+7 more

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.

+4 more

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: 18F-fluciclovineExperimental Treatment2 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.