Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

MRI Before and During Surgery in Diagnosing Patients With Bladder Cancer

Protocol: OSU-08063

Full Title

Imaging of the Bladder Tumor Using Clinical 3 Tesla MRI and Ex-Vivo Ultra-high-field MRI

Purpose

The purpose of the research study is to see if stronger magnetic resonance imaging (MRI) machines can provide more information about bladder cancer before and during surgery.

Study Objective

PRIMARY OBJECTIVES:

I. To evaluate whether 3 Tesla MRI can accurately determine the primary tumor (T) stage and pelvic lymph nodes (N) stage for localized bladder cancer. The ability of 3 Tesla MRI to accurately assign stage will be compared to histopathology staging.

SECONDARY OBJECTIVES:

I. To determine whether 3 Tesla MRI can determine if the primary bladder tumor is responding to neoadjuvant chemotherapy at the mid-point of the planned treatment (after 2 cycles).

II. To assess whether an ultra-high-field MRI (> 3 Tesla) tissue scan can more accurately determine clinical stage of a primary bladder tumor and regional lymph nodes.

OUTLINE:

All patients undergo 3-Tesla MRI scans 2-4 weeks before surgery. Patients receiving neoadjuvant chemotherapy also undergo 3-Tesla MRI scans before the start of chemotherapy and after 2 courses of chemotherapy. Specimens collected during surgery are then assessed via ultra-high-field MRI.

Are you eligible?

Inclusion Criteria:

Patient with known bladder cancer

Patient is scheduled for radical cystectomy and lymph node dissection

Patient is able and willing to give valid written informed consent

Patient has no contraindications to the MRI

Exclusion Criteria:

Women who are pregnant or planning to become pregnant during the trial

Women who are breastfeeding

Patient with allergy to contrast agent

Patient with significant renal insufficiency, i.e. an estimated glomerular filtration rate (eGRF) less than 30 mL/min/1.73m^2

Any condition conflict based on the investigation’s clinical judgment that would prevent the patient from completion all trial assessments and visits

Inability or unwillingness to cooperate with requirements of this trial

Patients who exhibit noticeable anxiety and/or claustrophobia or who exhibit severe vertigo when they are moved into the MR

Patients with sickle cell anemia and other hemolytic anemia

Bladder Cancer Genitourinary Cancers