PET/MRI and Biomarkers in Bladder Cancer
Conditions
Bladder Cancer
Conditions: official terms
Urinary Bladder Neoplasms
Conditions: Keywords
bladder cancer, neoadjuvant chemotherapy, radical cystectomy, lymphadenectomy, biomarker
Study Type
Interventional
Study Phase
N/A
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: MRI/acetate-PET imaging
Type: Device
Overall Status
Recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 85 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Helsinki University Hospital
Helsinki, Finland
Status: Recruiting
Contact: Ilmari Koskinen, MD - ilmari.koskinen@hus.fi
Tampere University Hospital
Tampere, Finland
Status: Recruiting
Contact: Andres Kotsar, MD - andres.kotsar@gmail.com
Turku University Hospital
Turku, Finland
Status: Recruiting
Contact: Peter Bostrom, MD
Start Date
August 2013
Completion Date
November 2016
Sponsors
Turku University Hospital
Source
Turku University Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page