3 Tesla MRI in Patients With Bladder Cancer

Imaging of Bladder Cancer Using Clinical 3 Tesla MRI and EX-VIVO Ultra-High-Field MRI.

RATIONALE: New diagnostic procedures, such as 3 Tesla magnetic resonance imaging (MRI), may help find bladder cancer and learn the extent of disease.

PURPOSE: This clinical trial is studying how well 3 Tesla MRI works in finding cancer in patients with bladder cancer.

Study Overview

• Status: Completed
• Conditions: Bladder Cancer
• Intervention / Treatment: Procedure: Specimen Ultra-High field MRI; Procedure: Cystectomy and Lymphadenectomy; Drug: chemotherapy

Detailed Description

OBJECTIVES:

Primary

• To evaluate whether 3 Tesla MRI can accurately determine the primary tumor (T) stage and pelvic lymph nodes (N) stage in patients with localized bladder cancer as compared to histopathology staging.

Secondary

• 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 courses).
• To assess whether an ex-vivo ultra-high-field MRI (4.7-11.7 Tesla) tissue scan can more accurately determine clinical stage of a primary bladder tumor and local extent of the disease (i.e., involvement of contiguous organs and regional lymph nodes) as compared to histopathology staging.

OUTLINE: Patients may receive neoadjuvant chemotherapy (typically four 21-day courses of cisplatin-based therapy) followed by standard radical cystectomy and lymph node dissection.

Patients undergo a 3 Tesla MRI scan at baseline to stage the primary tumor, regional lymph nodes, and to rule out distant sites of disease. The MRI includes diagnostic high-resolution anatomical images (e.g., T1-weighted and T2-weighted images along axial or optimal directions) and experimental images including functional MRI (e.g., dynamic contrast-enhanced MRI, diffusion-weighted MRI, MR spectroscopy, and chemical exchange-dependent saturation-transfer imaging). Patients also undergo a 3 Tesla MRI scan after 2 courses of neoadjuvant chemotherapy and after completion of neoadjuvant chemotherapy. Patients not receiving neoadjuvant chemotherapy undergo a 3 Tesla MRI scan 2-4 weeks before radical cystectomy and lymph node dissection.

Specimens from the radical cystectomy and pelvic lymph node dissection are examined ex-vivo by ultra-high-field MRI and the Micro-Imaging Specimen Study Form is completed. The specimens are then examined by the pathology department as per standard routine.

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Known bladder cancer
• Scheduled for radical cystectomy and lymph node dissection.
• Able and willing to give valid written informed consent.
• No contraindications to the MRI(magnetic resonance imaging).

Exclusion Criteria:

• Not pregnant, planning to become pregnant during the study, or nursing.
• No allergy to contrast agents.
• Patient with significant renal insufficiency, i.e. an estimated glomerular filtration rate(eGRF) less than 30 mL/min/1.73m2.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MRI+surgery; 3 Tesla MRI/Cystectomy and Lymphadenectomy/Urinary Diversion/Specimen Ultra-High field MRI	Procedure: Specimen Ultra-High field MRI; Immediately following removal of the bladder and lymph nodes, the specimens will be transported to the ultra-high-field MRI scanner for high resolution imaging.; Procedure: Cystectomy and Lymphadenectomy; The patient will undergo radical cystectomy and pelvic lymph node dissection with no deviation from standard surgical care. A urinary tract reconstruction will follow as either a continent or incontinent form of diversion.; Other Names: surgery
Experimental: MRI+surgery+chemotherapy; 3 Tesla MRI/Cystectomy and Lymphadenectomy/Urinary Diversion/Specimen Ultra-High field MRI/chemotherapy	Procedure: Specimen Ultra-High field MRI; Immediately following removal of the bladder and lymph nodes, the specimens will be transported to the ultra-high-field MRI scanner for high resolution imaging.; Procedure: Cystectomy and Lymphadenectomy; The patient will undergo radical cystectomy and pelvic lymph node dissection with no deviation from standard surgical care. A urinary tract reconstruction will follow as either a continent or incontinent form of diversion.; Other Names: surgery; Drug: chemotherapy; The majority of patients will be candidates to receive neoadjuvant chemotherapy prior to radical cystectomy as part of standard clinical care. Patients will most often receive cisplatin based therapy for a period of three months (four 21 day cycles).; Other Names: chemo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Agreement in tumor staging between pathology and 3 Tesla MRI	up to 24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Agreement in lymph node staging between pathology and 3 Tesla MRI	up to 24 months

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Investigators: Principal Investigator: Michael V. Knopp, MD, PhD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2009
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: July 10, 2009
• First Submitted That Met QC Criteria: July 10, 2009
• First Posted (Estimated): July 13, 2009

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: stage III bladder cancer; recurrent bladder cancer; stage IV bladder cancer; stage II bladder cancer
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: OSU-08063; NCI-2012-00937 (Registry Identifier: Clinical Trials Reporting Program (CTRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes