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Fluciclovine PET/CT for Muscle-Invasive Bladder Cancer

Phase < 1

Waitlist Available

Led By Heather Jacene, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Radical cystectomy must be planned for the patient after the planned 18F-fluciclovine-PET/CT

ECOG performance status ≤2 (Karnofsky ≥60%)

Must not have

Participants with other known malignancies that has required treatment in the past 3 years

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new imaging agent to see if it can better detect bladder cancer that has spread to muscle tissue.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of 18F-fluciclovine aren't detailed here, PET/CT scans may cause discomfort due to lying still for long periods. Allergic reactions might occur but are generally rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am 18 years old or older.

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

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

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My bladder cancer diagnosis was confirmed through lab tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The agreement rate of metastatic disease status between 18F-fluciclovine-PET/CT and histopathology from radical cystectomy

Secondary study objectives

18F-fluciclovine uptake on PET/CT to the presence/absence of ASCT2 and LAT1 amino acid transporters.

The amount of 18F-fluciclovine accumulation in the primary bladder tumor on PET

The rate of detection of suspected distant metastatic disease by 18F-fluciclovine-PET/CT

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

18F-fluciclovine

2021

Completed Early Phase 1

~40

PET/CT

2022

Completed Phase 3

~1300