Radiogenomics of Muscle Invasive Bladder Cancer

NCT04806334 | Terminated Results FDA Device

• 1 other identifier: IIT2020-22-Rosser
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer Stage II

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Proceed With MRI Imaging and Sequencing of Bladder Tumor

  Number of participants who proceed with radiogenomics analysis with useable data, that is a preliminary signature related to MIBC.

  3 months

Study Arms (1)

4D MRI of pelvis/bladder with genomic analysis of bladder tumor

EXPERIMENTAL

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.

Diagnostic Test: MRI imaging of the pelvis/bladder; Diagnostic Test: genomic analysis of tumor

Interventions

MRI imaging of the pelvis/bladder DIAGNOSTIC_TEST

The pelvic MRI will be multiparametric (mp)-4D MRI incorporating high resolution diffusion weighted imaging (HR-DWI).

4D MRI of pelvis/bladder with genomic analysis of bladder tumor

genomic analysis of tumor DIAGNOSTIC_TEST

Single cell RNA sequencing of transurethral resection of bladder tumor (TURBT)

4D MRI of pelvis/bladder with genomic analysis of bladder tumor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 have adequate renal function: Serum creatinine \< 2 mg/dL OR calculated CrCl \> 30ml/min.
• Patients must not have allergy or contraindication for MRI contrast/contrast dye.
• Patients must not be 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.
• Patient must not be adverse to undergo radical cystectomy as part of the normal treatment course if found to have MIBC.
• Patients must have the ability to understand and willingness to sign a written informed consent.

You may not qualify if:

• Persons with allergy to animal dander or animal-instigated asthma.
• Patient must not have undergone a bladder biopsy or limited (incomplete) TURBT within 3 weeks (21 days) of the MRI.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Charles J Rosser, MD
• Organization: Cedars-Sinai Medical Center

Charles.rosser@cshs.org

310-423-3723

Study Officials

• Charles J Rosser, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Not studying the MRI device; it is looking at feasibility of creating a radiogenomic workflow to learn about the correlation structure between the radiomic and genomic parameters of interest. The study is not an ACT but should be registered to meet ICMJE recommendations.

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 19, 2021
• Study Start: March 2, 2021
• Primary Completion: September 9, 2023
• Study Completion: April 1, 2024
• Last Updated: April 18, 2024
• Results First Posted: December 26, 2023

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)