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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

July 10, 2009
July 13, 2009
September 25, 2017
May 2009
December 31, 2018   (Final data collection date for primary outcome measure)
Agreement in tumor staging between pathology and 3 Tesla MRI [ Time Frame: up to 24 months ]
Agreement in tumor staging between pathology and 3 Tesla MRI
Complete list of historical versions of study NCT00938145 on ClinicalTrials.gov Archive Site
Agreement in lymph node staging between pathology and 3 Tesla MRI [ Time Frame: up to 24 months ]
Agreement in lymph node staging between pathology and 3 Tesla MRI
Not Provided
Not Provided
 
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.

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.

Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Bladder Cancer
  • 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
  • Experimental: MRI+surgery
    3 Tesla MRI/Cystectomy and Lymphadenectomy/Urinary Diversion/Specimen Ultra-High field MRI
    Interventions:
    • Procedure: Specimen Ultra-High field MRI
    • Procedure: Cystectomy and Lymphadenectomy
  • Experimental: MRI+surgery+chemotherapy
    3 Tesla MRI/Cystectomy and Lymphadenectomy/Urinary Diversion/Specimen Ultra-High field MRI/chemotherapy
    Interventions:
    • Procedure: Specimen Ultra-High field MRI
    • Drug: chemotherapy
    • Procedure: Cystectomy and Lymphadenectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
65
Same as current
December 31, 2018
December 31, 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Ohio State University Comprehensive Cancer Center 1-800-293-5066 Jamesline@osumc.edu
Contact: Michael Knopp, MD, PhD 614-293-9998
United States
 
 
NCT00938145
OSU-08063
NCI-2012-00937 ( Registry Identifier: Clinical Trials Reporting Program (CTRP) )
Yes
Not Provided
Not Provided
Michael Knopp, Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
Not Provided
Principal Investigator: Michael V. Knopp, MD, PhD Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP