US Medical Center started a clinical trial of Radiogenomics of Muscle Invasive Bladder Cancer
Cedars-Sinai Medical Center is recruiting patients for the clinical trial of Radiogenomics of Muscle Invasive Bladder Cancer.
Among study population are 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.
March 2, 2021 is the study start date. The indicative completion of the clinical trial will be expected in December 30, 2022.
Among primary outcome measures are the Number of participants who proceed with MRI imaging and sequencing of bladder tumor.
The study will take place at the Cedars-Sinai Medical Center, Los Angeles, California, United States.
Among the inclusion criteria are:
- 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.
and others.
There are a number of conditions that do not allow participation, such as:
- 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.
The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT04806334
