Radiogenomics for Bladder Cancer

Recruiting in Palo Alto (17 mi)

Overseen ByCharles J Rosser, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Cedars-Sinai Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Adults over 18 with suspected muscle invasive bladder cancer (MIBC) who haven't had prior definitive treatment for it. They must be willing to undergo specific MRI imaging, tumor removal surgery (TURBT), and potentially a radical cystectomy if MIBC is confirmed. Participants should not have other active cancers or serious infections, allergies to MRI contrast dye, known distant metastases except certain cases of abdominal/pelvic lymphadenopathy, or be on recent immunosuppressive medications.

Inclusion Criteria

I am older than 18 years.

I have not had any definitive treatment for bladder cancer.

I do not have cancer in my ureter, urethra, or renal pelvis.

My kidney function is good, with creatinine below 2 mg/dL or CrCl above 30 ml/min.

I agree to have advanced MRI scans of my pelvis and standard scans of my abdomen.

I can understand and am willing to sign the consent form.

I agree to have a bladder tumor removal surgery as part of my treatment.

I have a growth in my bladder that may be muscle-invasive bladder cancer.

Participant Groups

The trial is testing the combination of advanced 4D MRI imaging and genomic analysis of the tumor cells from patients with suspected MIBC. The goal is to find a radiogenomic signature that could help in accurately staging bladder cancer which may lead to better treatment strategies.

1Treatment groups

Experimental Treatment

Group I: 4D MRI of pelvis/bladder with genomic analysis of bladder tumorExperimental Treatment2 Interventions

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 will be enrolled. 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 interpretation by a radiologist, thus both can be used in the care of the subject. Next, ALL subjects will undergo TURBT at which time, voided urine, blood and fresh frozen bladder tumor will be collected. Follow-up pathology will be collected.