NCT04806334

Radiogenomics of Muscle Invasive Bladder Cancer

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with suspected bladder tumor will undergo novel 4D MRI imaging along with single cell RNA sequencing in hopes of identifying a radiogenomic signature that can improve our staging of patients with muscle invasive bladder cancer.

Detailed description

The study will accrue patients with sessile appearing bladder masses who are destined to undergo transurethral resection of the bladder tumor (TURBT) and are felt by the treating physician to harbor MIBC. Prior to TURBT, ALL subjects will undergo axial imaging for clinical staging in the form of contrast enhanced MRI of the abdomen and pelvis (standard of care). The pelvic MRI will be multiparametric (mp)-4D MRI incorporating high resolution diffusion weighted imaging (HR-DWI). Both the abdominal and pelvic MRI will have an official intrepretation by a radiologist, thus both can be used in the care of the subject. Next, ALL subjects will undergo TURBT at which time fresh frozen bladder tumor will be collected and subjected to single cell RNA sequencing. Pathologic stage will be determined and reported on both the TURBT specimen and radical cystectomy specimen. From the above radiogenomic data, the investigators will show feasibility, which the investigators will define as know-how to create a radiogenomic workflow and to learn about the correlation structure between the radiomic and genomic parameters of interest, which will allow the investigators to design future studies with adequate power.

Conditions

• Bladder Cancer Stage II

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	MRI imaging of the pelvis/bladder	The pelvic MRI will be multiparametric (mp)-4D MRI incorporating high resolution diffusion weighted imaging (HR-DWI).
DIAGNOSTIC_TEST	genomic analysis of tumor	Single cell RNA sequencing of transurethral resection of bladder tumor (TURBT)

Timeline

• Start date: 2021-03-02
• Primary completion: 2023-09-09
• Completion: 2024-04-01
• First posted: 2021-03-19
• Last updated: 2024-04-18
• Results posted: 2023-12-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study