Radiogenomics of Muscle Invasive Bladder Cancer

INTRODUCTION

  • Org Study ID: IIT2020-22-Rosser
  • Secondary ID: N/A
  • NTC ID: NCT04806334
  • Sponsor: Cedars-Sinai Medical Center

BRIEF 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.

  • Overall Status
    Recruiting
  • Start Date
    March 2, 2021
  • Phase
    Not Applicable
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Number of participants who proceed with MRI imaging and sequencing of bladder tumor

Primary Outcome 1 - Timeframe: 3 months

CONDITION

  • Bladder Cancer Stage II

ELIGIBILITY

Inclusion Criteria:
Patients must be > 18 years of age.

- Patient must have a sessile mass noted within the bladder on cystoscopy or imaging worrisome for bladder cancer, specifically MIBC.

- Patient must agree to undergo staging which will include mp-4D MRI HR-DWI of the pelvis in addition to standard axial imaging of the abdomen.

- Patient must be agreeable to undergo planned TURBT as part of the normal treatment course.

- Patients must not have known or suspected primary urothelial carcinoma of the ureter, urethra, or renal pelvis.

- Patients must not have known distant metastatic disease (e.g. pulmonary or hepatic metastases). Subjects with malignant lymphadenopathy in the abdomen or pelvis considered appropriate for radical cystectomy and lymphadenectomy with the goal of complete resection of all malignant disease are allowed.

- Patients must not have had prior definitive treatment for bladder cancer.

- Patients must not have clinically significant active infection or uncontrolled medical condition that would preclude participation in study.

- Patients must not have any active malignancy other than urothelial carcinoma of the bladder that, in the opinion of the treating investigator, which could interfere with protocol treatment.

- Patient must not be adverse to undergo radical cystectomy as part of the normal treatment course if found to have MIBC.
Exclusion Criteria:
Patients unable to understand and unwillingness to sign a written informed consent.

- Patient have serum creatinine > 2 mg/dL OR calculated CrCl < 30ml/min. - Patients have allergy or contraindication for MRI contrast/contrast dye. - Patients are under treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to TURBT.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Charles J Rosser, MD

Role: Principal Investigator

Affiliation: Cedars-Sinai Medical Center

Overall Contact

Name: Charles J Rosser, MD

Phone: 310-423-3723

Email: Charles.rosser@cshs.org

LOCATION

Facility Status Contact
Facility: Cedars-Sinai Medical Center
Los Angeles, California 90048
United States
Status: Recruiting Contact: Contact
Charles J Rosser, MD, MBA
310-423-3713
Charles.rosser@cshs.org