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Radiogenomics of Muscle Invasive Bladder Cancer

Primary Purpose

Bladder Cancer Stage II

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

MRI imaging of the pelvis/bladder

genomic analysis of tumor

About this trial

This is an interventional other trial for Bladder Cancer Stage II

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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.

Exclusion Criteria:

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.

Sites / Locations

Cedars-Sinai Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04806334

First Posted

March 10, 2021

Last Updated

September 12, 2023

Sponsor

Cedars-Sinai Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04806334

Brief Title

Radiogenomics of Muscle Invasive Bladder Cancer

Official Title

Radiogenomics of Muscle Invasive Bladder Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 2, 2021 (Actual)

Primary Completion Date

September 9, 2023 (Actual)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cedars-Sinai Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bladder Cancer Stage II

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

MRI imaging of the pelvis/bladder

Intervention Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

genomic analysis of tumor

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of participants who proceed with MRI imaging and sequencing of bladder tumor

Description

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

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Charles J Rosser, MD

Organizational Affiliation

Cedars-Sinai Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cedars-Sinai Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Radiogenomics of Muscle Invasive Bladder Cancer

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