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MRI in Clinical Staging and Estimation of Treatment Response in Bladder Cancer (MIB)

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ClinicalTrials.gov Identifier: NCT02662166
Recruitment Status : Recruiting
First Posted : January 25, 2016
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Peter Boström, Turku University Hospital

Brief Summary:
Bladder cancer (BC) as the most common malignancy arising from the urinary tract continues to be a major health problem. This prospective non-randomized study will enroll 150 patients undergoing magnetic resonance imaging (MRI) at different stages of their diagnostic and therapeutical process. The enrolled patients with suspected BC (BC) based on cystoscopy will have their initial MRI examination before transurethral resection of bladder tumor (TUR-BT) and biomarker collection. After pathology review of the histological specimens, patients will be treated according to standard clinical practice. The second MRI examination will be performed before therapeutic intervention, if TUR-BT alone is not sufficient enough. Neoadjuvant chemotherapy will be applied in high risk patients having muscle invasison, while intermediate risk patient - T1 high grade or carcinoma in situ patients - will be treated using Bacillus Calmette-Guerin (BCG) instilliations. After the completion of the neoadjuvant chemotherapy or BCG treatment, the patients will undergo the third MRI examination. Low risk patients will be followed by annual with MRI examination.

Condition or disease Intervention/treatment Phase
Bladder Cancer Device: MR imaging Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Magnetic Resonance Imaging of Bladder Cancer
Actual Study Start Date : July 2014
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MRI and biomarkers in bladder cancer
Utilization of MR-imaging and biomarkers to stage bladder cancer and in estimation of chemosensitivity
Device: MR imaging
3 T MRI of the urinary bladder




Primary Outcome Measures :
  1. Accuracy of the multiparametric MRI (anatomical MRI, DCE-MRI, DWI) in the staging of bladder cancer [ Time Frame: 24 months ]
    The accuracy of multiparametric MRI (anatomical MRI, DCE-MRI, DWI) in the staging of bladder cancer will be evaluated using transurethral resection of bladder tumor and cystectomy specimens


Secondary Outcome Measures :
  1. Prediction of response to neo-adjuvant chemotherapy and/or BCG treatment evaluated by multiparametric MRI (anatomical MRI, DCE-MRI, DWI) [ Time Frame: 24 months ]
    The aim is to evaluate predictive power of multiparametric MRI for estimation neo-adjuvant chemotherapy and/or BCG treatment response. Multiparametric MRI will be performed before neo-adjuvant chemotherapy and/or BCG treatment and patients will be followed using standard clinical follow up and/or undergo cystectomy.


Other Outcome Measures:
  1. Estimation of chemosensitivity [ Time Frame: 24 months ]
    Prevalence of patients responding neo-adjuvant chemotherapy, compared with the non-responders as evaluated by cystectomy specimens, according to various biomarkers and ex vivo tissue culturing will be evaluated.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 18 to 85 years old
  • Suspected BC based on cystoscopical evaluation.
  • Mental status: Patients must be able to understand the meaning of the study
  • Informed consent: The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff

Exclusion Criteria:

  • History of serious cardiovascular, liver or kidney disease
  • Uncontrolled serious infection
  • Contraindications for MRI (cardiac pacemaker, intracranial clips etc)
  • Patient refusing radical cystectomy or chemotherapy or BCG
  • Intravesical Bacillus Calmette-Guerin instillations within 6 months before the first MRI examination

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02662166


Contacts
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Contact: Peter Boström, MD, PhD +358 2 313 5925 peter.bostrom@tyks.fi
Contact: Ivan Jambor, MD ivjamb@utu.fi

Locations
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Finland
Department of Urology, Central Hospital of Pori Not yet recruiting
Pori, Finland
Contact: Antti Kaipia, MD         
University of Turku Recruiting
Turku, Finland, 20100
Contact: Peter J Bostrom, MD, PhD    +358-2-3135925    peter.bostrom@tyks.fi   
Sub-Investigator: Antti Salminen, MD         
Sponsors and Collaborators
Turku University Hospital
Investigators
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Principal Investigator: Peter Boström, MD, PhD Department of Urology, University of Turku and Turku University Hospital

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Responsible Party: Peter Boström, MD, PhD, Deah of Department, Turku University Hospital
ClinicalTrials.gov Identifier: NCT02662166     History of Changes
Other Study ID Numbers: 6/1801/2014
First Posted: January 25, 2016    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018

Keywords provided by Peter Boström, Turku University Hospital:
bladder cancer
MRI
TUR-BT
cystectomy
chemotherapy

Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases