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


N/A
18 Years
N/A
Open (Enrolling)
Both
Bladder Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Single Blind, Primary Purpose: Diagnostic

Outcome Measure:

Agreement in tumor staging between pathology and 3 Tesla MRI

Safety Issue:

No

Principal Investigator

Michael V. Knopp, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University Comprehensive Cancer Center

Authority:

Unspecified

Study ID:

CDR0000648533

NCT ID:

NCT00938145

Start Date:

May 2009

Completion Date:

Related Keywords:

  • Bladder Cancer
  • recurrent bladder cancer
  • stage II bladder cancer
  • stage III bladder cancer
  • stage IV bladder cancer
  • Urinary Bladder Neoplasms

Name

Location
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Columbus, Ohio  43210-1240