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NCT01918592 Clinical Trial

PET/MRI and Biomarkers in Bladder Cancer

Bladder Cancer Clinical Trial

— ACEBIB  

Official title:
PET/MRI and Biomarkers in Clinical Staging of Bladder Cancer and in the Estimation of Neoadjuvant Chemotherapy Response Prior to Radical Cystectomy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01918592
Other study ID # ACEBIB
Secondary ID
Status Completed
Phase N/A
First received August 5, 2013
Last updated April 16, 2018
Start date August 2013
Est. completion date November 2016

Study information
Verified date April 2018
Source Turku University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date November 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• MRI/acetate-PET imaging

Locations
Country Name City State
Finland Helsinki University Hospital Helsinki
Finland Tampere University Hospital Tampere
Finland Turku University Hospital Turku

Sponsors (1)
Lead Sponsor Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Other Accuracy of prognostic biomarkers to estimate response to neoadjuvant chemotherapy. Accuracy of tissue, blood and urine based biomarkers to estimate response to neoadjuvant chemotherapy is estimated 6 mo
Primary 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. 3 months
Secondary 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. 3 mo
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