3 Tesla MRI in Patients With Bladder Cancer

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    180
  • sponsor
    Ohio State University Comprehensive Cancer Center
Updated on 2 May 2022
radical cystectomy
cancer
lymphadenectomy
bladder cancer
bladder tumor

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.

Details
Condition Bladder Cancer
Treatment Chemotherapy, Specimen Ultra-High field MRI, Cystectomy and Lymphadenectomy
Clinical Study IdentifierNCT00938145
SponsorOhio State University Comprehensive Cancer Center
Last Modified on2 May 2022

Eligibility

Yes No Not Sure

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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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