PET/MRI and Biomarkers in Bladder Cancer

N/ACompletedNCT01918592

Turku University Hospital25 enrolled

Overview

Muscle invasive bladder cancer is an aggressive malignancy. Currently the investigators lack accurate imaging technologies in clinical staging and estimation of response to neoadjuvant chemotherapy as well as prognostic biomarkers. In the current study novel imaging modality (MRI/PET) is utilized to stage bladder cancer prior to transurethral resection of bladder-tumor and after neoadjuvant chemotherapy. Also prognostic biomarkers are studied from TUR-BT tissues, blood and urine to estimate response to neoadjuvant chemotherapy.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Bladder Cancer

Interventions

MRI/acetate-PET imagingDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * invasive or locally advanced bladder cancer based on cystoscopic evaluation * Age: 18 to 85 years old * Language spoken: Finnish or Swedish * 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: * Prior medical history: Patient must have no history of serious cardiovascular, liver or kidney disease * Infections: Patient must not have an uncontrolled serious infection * Contraindications for MRI (cardiac pacemaker, intracranial clips etc) * Patient refusing radical cystectomy or chemotherapy * Intravesical Bacillus Calmette-Guerin instillations within 6 months

Locations (3)

Helsinki University Hospital

Helsinki, Finland

Tampere University Hospital

Tampere, Finland

Turku University Hospital

Turku, Finland

Outcomes

Primary Outcomes

staging accuracy of PET/MRI in bladder cancer

Accuracy of PET/MRI to stage newly diagnosed bladder cancer. MRI/PET staging results is compared to pathology report of TUR-BT and cystectomy specimens.

Time frame: 3 months

Secondary Outcomes

Accuracy of PET/MRI to estimate response to neoadjuvant chemotherapy

Accuracy of PET/MRI to estimate response to neoadjuvant chemotherapy prior to radical cystectomy. MRI/PET results is compared to pathology report of cystectomy specimen.

Time frame: 3 mo

Data from ClinicalTrials.gov

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