18Fluorine-Fluciclovine PET/CT for Staging Muscle Invasive Bladder Cancer Preceding Radical Cystectomy

Bladder Cancer Clinical Trial

Official title: A Pilot Study of 18Fluorine-Fluciclovine Positron Emission Tomography/Computed Tomography for Staging Muscle Invasive Bladder Cancer Preceding Radical Cystectomy

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

This research study is a pilot study, which is the first-time investigators are examining this study imaging agent, 18F-fluciclovine, for use in imaging bladder cancer.

Staging of muscle invasive bladder cancer is currently done using computed tomography (CT) and/or magnetic resonance imaging (MRI). Both CT and MRI are useful to determine the extent of bladder cancer, but some studies show that up to 40% of patients with negative CT or MRI scans for disease outside the bladder are found to have disease outside the bladder (in lymph nodes near the bladder) at the time of surgery.

Given the limitations of the imaging exams currently used for staging bladder cancer, new techniques and imaging agents that can better identify metastatic lesions, especially within the pelvis, are desired and would be very useful.

18F-fluciclovine is a new radiotracer that was recently approved to evaluate lesions in recurrent prostate cancer (but not for bladder cancer). This radiotracer targets amino-acid receptors, which are overexpressed in multiple cancers. Studies have shown that 18F-fluciclovine PET/CT can visualize other types of cancers, such as breast cancer. A major advantage of 18F-fluciclovine is that it does not get into the bladder during the time of imaging. This may make it easier to see disease in the pelvis that is outside the bladder.

The purpose of this study to determine whether 18F-fluciclovine PET/CT can better stage muscle invasive bladder cancer compared to conventional CT or MRI. A secondary aim of this study is to determine whether 18F-fluciclovine PET/CT can reveal the pathologic grade of the bladder cancer, which is only determined from pathology specimens obtained at surgery. ;

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma, Transitional Cell
• Urinary Bladder Neoplasms
• Urothelial Carcinoma

• NCT number: NCT04018053
• Study type: Interventional
• Source: Dana-Farber Cancer Institute
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: February 26, 2020
• Completion date: December 30, 2024