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BRIEF TITLE: Radiogenomics of Muscle Invasive Bladder Cancer

Radiogenomics of Muscle Invasive Bladder Cancer


  • Org Study ID: IIT2020-22-Rosser
  • Secondary ID:
  • NCT ID: NCT04806334
  • NCT Alias:
  • Sponsor: Cedars-Sinai Medical Center - Other
  • Source: 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.

Overal Status Start Date Phase Study Type
Recruiting March 2, 2021 N/A Interventional

Primary Outcomes:

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

Primary Outcome 1 - Time Frame: 3 months

Condition:

  • Bladder Cancer Stage II

Eligibility

Criteria:
Inclusion Criteria:

1. Patients must be > 18 years of age.

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

3. 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.

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

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

6. 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.

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

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

9. 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.

10. Patient must not be adverse to undergo radical cystectomy as part of the normal
treatment course if found to have MIBC.

Exclusion Criteria:

1. Patients unable to understand and unwillingness to sign a written informed consent.

2. Patient have serum creatinine > 2 mg/dL OR calculated CrCl < 30ml/min.

3. Patients have allergy or contraindication for MRI contrast/contrast dye.

4. 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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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
Cedars-Sinai Medical Center
Los Angeles, California 90048
United States
Recruiting Charles J Rosser, MD, MBA
310-423-3713
Charles.rosser@cshs.org