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

Turku University Hospital (TYKS)

Status: Completed

Conditions: Bladder Cancer

Treatments: Device: MR imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT02662166

6/1801/2014

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

MRI and biomarkers in bladder cancer

Experimental group

Description:

Utilization of MR-imaging and biomarkers to stage bladder cancer and in estimation of chemosensitivity

Treatment:

Device: MR imaging