Fluciclovine PET/CT for Muscle-Invasive Bladder Cancer

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

I am 18 years old or older.

My cancer is at a stage where it has grown but not spread to lymph nodes.

My scans show no signs of cancer spread beyond the original site.

My bladder cancer diagnosis was confirmed through lab tests.

Exclusion Criteria

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

I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

Treatment Details

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.