Clinical trial

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

Name

OSU-08063

Description

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.

Trial arms

Trial start

2009-07-08

Estimated PCD

2024-12-31

Trial end

2024-12-31

Status

Active (not recruiting)

Treatment

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.

Arms:

MRI+surgery, MRI+surgery+chemotherapy

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).

Arms:

MRI+surgery+chemotherapy

Other names:

chemo

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.

Arms:

MRI+surgery, MRI+surgery+chemotherapy

Other names:

surgery

Size

Primary endpoint

Agreement in tumor staging between pathology and 3 Tesla MRI

up to 24 months

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 98, 'type': 'ACTUAL'}}

Updated at

2024-05-08

1 organization

1 drug

1 indication

Organization

University of Cincinnati

Drug

cyclophosphamide

Indication

Bladder Cancer