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NCT Number: NCT02662166

MRI in Clinical Staging and Estimation of Treatment Response in Bladder Cancer

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.

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Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Urology, Central Hospital of Pori, Pori, Finland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MR Imaging

Device

3 T MRI of the urinary bladder

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Registry information

Official study title

Magnetic Resonance Imaging of Bladder Cancer

Acronym: MIB

Important dates

Study start
2014
Primary completion
2019
Study completion
2020
First posted
Jan 25, 2016
Registry last updated
Jun 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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