Clinical trial NCT02662166: MRI in Clinical Staging and Estimation of Treatment Response in Bladder Cancer
Official title: Magnetic Resonance Imaging of Bladder Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Keywords: bladder cancer
MRI
TUR-BT
cystectomy
chemotherapy
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2016-01-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: Accuracy of the multiparametric MRI (anatomical MRI, DCE-MRI, DWI) in the staging of bladder cancer
timeFrame: 24 months
Secondary outcomes:
measure: Prediction of response to neo-adjuvant chemotherapy and/or BCG treatment evaluated by multiparametric MRI (anatomical MRI, DCE-MRI, DWI)
timeFrame: 24 months
Other outcomes:
measure: Estimation of chemosensitivity
timeFrame: 24 months
Locations:
city: Pori
country: Finland
facility: Department of Urology, Central Hospital of Pori
city: Turku
country: Finland
facility: University of Turku
Study officials:
affiliation: Department of Urology, University of Turku and Turku University Hospital
name: Peter Boström, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nikulainen I, Salminen AP, Jambor I, Merisaari H, Tammilehto V, Taimen P, Seikkula H, Bostrom PJ. Visual MRI T-category versus VI-RADS evaluation from multiparametric MRI in the detection of muscle-invasion in patients with suspected bladder cancer: single centre registered clinical trial (MIB-trial). Scand J Urol. 2021 Oct;55(5):354-360. doi: 10.1080/21681805.2021.1971290. Epub 2021 Aug 27.