3 Tesla MRI in Patients With Bladder Cancer

NCT00938145 | Active Not Recruiting DMC FDA Device

• 2 other identifiers: OSU-08063NCI-2012-00937
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bladder Cancer

Keywords

recurrent bladder cancer; stage II bladder cancer; stage III bladder cancer; stage IV bladder cancer

Outcome Measures

Primary Outcomes (1)

• Agreement in tumor staging between pathology and 3 Tesla MRI

  up to 24 months

Secondary Outcomes (1)

• Agreement in lymph node staging between pathology and 3 Tesla MRI

  up to 24 months

Study Arms (2)

MRI+surgery

EXPERIMENTAL

3 Tesla MRI/Cystectomy and Lymphadenectomy/Urinary Diversion/Specimen Ultra-High field MRI

Procedure: Specimen Ultra-High field MRI; Procedure: Cystectomy and Lymphadenectomy

MRI+surgery+chemotherapy

EXPERIMENTAL

3 Tesla MRI/Cystectomy and Lymphadenectomy/Urinary Diversion/Specimen Ultra-High field MRI/chemotherapy

Procedure: Specimen Ultra-High field MRI; Drug: chemotherapy; Procedure: Cystectomy and Lymphadenectomy

Interventions

Specimen Ultra-High field MRI PROCEDURE

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.

MRI+surgery; MRI+surgery+chemotherapy

chemotherapy DRUG

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).

Also known as: chemo

MRI+surgery+chemotherapy

Cystectomy and Lymphadenectomy PROCEDURE

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.

Also known as: surgery

MRI+surgery; MRI+surgery+chemotherapy

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Drug Therapy; Cystectomy; Lymph Node Excision; Surgical Procedures, Operative

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

Intervention Hierarchy (Ancestors)

Therapeutics; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Michael V. Knopp, MD, PhD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 10, 2009
• First Posted: July 13, 2009
• Study Start: July 8, 2009
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)