PET/MRI and Biomarkers in Bladder Cancer (ACEBIB)

Turku University Hospital (TYKS)

Status: Completed

Conditions: Bladder Cancer

Treatments: Device: MRI/acetate-PET imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT01918592

ACEBIB

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

MRI/PET

Experimental group

Treatment:

Device: MRI/acetate-PET imaging