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3 Tesla MRI in Patients With Bladder Cancer

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ClinicalTrials.gov Identifier: NCT00938145
Recruitment Status : Recruiting
First Posted : July 13, 2009
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
Michael Knopp, Ohio State University Comprehensive Cancer Center

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.


Condition or disease Intervention/treatment
Bladder Cancer Procedure: Specimen Ultra-High field MRI Drug: chemotherapy Procedure: Cystectomy and Lymphadenectomy

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  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Imaging of Bladder Cancer Using Clinical 3 Tesla MRI and EX-VIVO Ultra-High-Field MRI.
Study Start Date : May 2009
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer
U.S. FDA Resources

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 Name: 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.
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 Name: chemo
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 Name: surgery



Primary Outcome Measures :
  1. Agreement in tumor staging between pathology and 3 Tesla MRI [ Time Frame: up to 24 months ]

Secondary Outcome Measures :
  1. Agreement in lymph node staging between pathology and 3 Tesla MRI [ Time Frame: up to 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00938145


Contacts
Contact: Ohio State University Comprehensive Cancer Center 1-800-293-5066 Jamesline@osumc.edu
Contact: Michael Knopp, MD, PhD 614-293-9998

Locations
United States, Ohio
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Michael Knopp, MD, PhD    614-293-9998    knopp.16@osu.edu   
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Michael V. Knopp, MD, PhD Ohio State University Comprehensive Cancer Center

Additional Information:
Responsible Party: Michael Knopp, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00938145     History of Changes
Other Study ID Numbers: OSU-08063
NCI-2012-00937 ( Registry Identifier: Clinical Trials Reporting Program (CTRP) )
First Posted: July 13, 2009    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017

Keywords provided by Michael Knopp, Ohio State University Comprehensive Cancer Center:
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