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

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


  • Org Study ID: OSU-08063
  • Secondary ID: NCI-2012-00937
  • NCT ID: NCT00938145
  • NCT Alias:
  • Sponsor: Ohio State University Comprehensive Cancer Center - Other
  • Source: 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.

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.

Overal Status Start Date Phase Study Type
Recruiting Start Date: May 2009 N/A Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Agreement in tumor staging between pathology and 3 Tesla MRI

Primary Outcome 1 - Time Frame: up to 24 months

Condition:

  • Bladder Cancer

Eligibility

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.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Michael V. Knopp, MD, PhD

Role: Principal Investigator

Affiliation: Ohio State University Comprehensive Cancer Center

Overall Contact

Name: Ohio State University Comprehensive Cancer Center

Phone: 1-800-293-5066

Email: Jamesline@osumc.edu

Link: The Jamesline

Location

Facility Status Contact
Ohio State University Medical Center
Columbus, Ohio 43210
United States
Recruiting Michael Knopp, MD, PhD
614-293-9998
knopp.16@osu.edu