3 Tesla MRI in Patients With Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00938145
• Other study ID #: OSU-08063
• Secondary ID: NCI-2012-00937
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 8, 2009
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 98
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

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).

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.

Locations

Country	Name	City	State
United States	Ohio State University Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agreement in tumor staging between pathology and 3 Tesla MRI		up to 24 months
Secondary	Agreement in lymph node staging between pathology and 3 Tesla MRI		up to 24 months

External Links

•   The Jamesline