3 Tesla MRI in Patients With Bladder Cancer
Recruitment status was Recruiting
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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. |
- Agreement in tumor staging between pathology and 3 Tesla MRI [ Designated as safety issue: No ]
- 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) |
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 |
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| 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 | |
| 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 May 23, 2013