3 Tesla MRI in Patients With Bladder Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00938145
First received: July 10, 2009
Last updated: April 6, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention
Bladder Cancer
Drug: cisplatin
Other: specimen ultra-high-field magnetic resonance imaging
Procedure: 3-Tesla magnetic resonance imaging
Procedure: diffusion-weighted magnetic resonance imaging
Procedure: dynamic contrast-enhanced magnetic resonance imaging
Procedure: functional magnetic resonance imaging
Procedure: magnetic resonance spectroscopic imaging
Procedure: neoadjuvant therapy

Study Type: Interventional
Study Design: Masking: Single Blind
Primary Purpose: Diagnostic
Official Title: Imaging of Bladder Cancer Using Clinical 3 Tesla MRI and EX-VIVO Ultra-High-Field MRI.

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Agreement in tumor staging between pathology and 3 Tesla MRI [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Agreement in lymph node staging between pathology and 3 Tesla MRI [ Designated as safety issue: No ]

Estimated Enrollment: 65
Study Start Date: May 2009
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Known bladder cancer
  • Undergoing treatment at the James Cancer Hospital and Solove Research Institute at Ohio State University
  • Scheduled for radical cystectomy and lymph node dissection

PATIENT CHARACTERISTICS:

  • Estimated GFR ≥ 30 mL/min (no significant renal insufficiency)
  • Not pregnant, planning to become pregnant during the study, or nursing
  • Able and willing to cooperate with study requirements
  • Able to communicate with the researcher
  • No contraindications to MRI, including any of the following:

    • Bio-implant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps)
    • Ferromagnetic bioimplant that could potentially be displaced or damaged
    • Vascular or aneurysm clips or metallic staples from a surgical procedure
    • Permanent tattoo eye liner
    • Possible shrapnel imbedded in the body, such as from war wounds, metal workers and machinists, or severe auto-accident victims
  • No patients who exhibit noticeable anxiety and/or claustrophobia or who exhibit severe vertigo when they are moved into the MRI machine
  • No sickle cell anemia or other hemolytic anemia
  • No cardiac or known circulatory impairment and/or the inability to perspire (poor thermoregulatory function)
  • No allergy or hypersensitivity reactions to contrast agents (gadolinium or any other ingredients, including benzyl alcohol)
  • No limited mental inability to give informed consent, mental retardation, altered mental status, mental disability, confusion, or psychiatric disorders
  • Not a prisoner
  • No other condition or conflict that would, in the investigator's judgement, prevent the patient from completing all trial assessments and visits

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00938145

Locations
United States, Ohio
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210-1240
Contact: Ohio State University Cancer Clinical Trial Matching Service    866-627-7616    osu@emergingmed.com   
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Michael V. Knopp, MD, PhD Ohio State University Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Michael V. Knopp, Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00938145     History of Changes
Other Study ID Numbers: CDR0000648533, OSU-08063, 2009C0001
Study First Received: July 10, 2009
Last Updated: April 6, 2010
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent bladder cancer
stage II bladder cancer
stage III bladder cancer
stage IV bladder cancer

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014