PET/MRI and Biomarkers in Bladder Cancer

Not Applicable

Completed

• Conditions: Bladder Cancer
• Interventions: Device: MRI/acetate-PET imaging

• Registration Number: NCT01918592
• Lead Sponsor: Turku University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-05
• Study First Submitted QC: 2013-08-07
• Study First Posted: 2013-08-08
• Primary Completion: 2016-03
• Study Completion: 2016-11
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-16
• Last Update Posted: 2018-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRI/PET	MRI/acetate-PET imaging	-

Primary Outcome Measures

Name	Time	Method
staging accuracy of PET/MRI in bladder cancer	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Accuracy of PET/MRI to estimate response to neoadjuvant chemotherapy	3 mo	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.

Trial Locations

Locations (3)

Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Tampere University Hospital; 🇫🇮 Tampere, Finland

Turku University Hospital; 🇫🇮 Turku, Finland