Radiogenomics of Muscle Invasive Bladder Cancer

  • STATUS
    Recruiting
  • End date
    Dec 30, 2022
  • participants needed
    20
  • sponsor
    Cedars-Sinai Medical Center
Updated on 7 April 2021

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.

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.

Details
Condition Bladder Cancer Stage II
Treatment MRI imaging of the pelvis/bladder, genomic analysis of tumor
Clinical Study IdentifierNCT04806334
SponsorCedars-Sinai Medical Center
Last Modified on7 April 2021

Eligibility

Yes No Not Sure

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
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