PET/MRI and Biomarkers in Bladder Cancer (ACEBIB)

This study is currently recruiting participants.
Verified January 2014 by Turku University Hospital
Sponsor:
Information provided by (Responsible Party):
Peter Boström, Turku University Hospital
ClinicalTrials.gov Identifier:
NCT01918592
First received: August 5, 2013
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Bladder Cancer
Device: MRI/acetate-PET imaging

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: PET/MRI and Biomarkers in Clinical Staging of Bladder Cancer and in the Estimation of Neoadjuvant Chemotherapy Response Prior to Radical Cystectomy

Resource links provided by NLM:


Further study details as provided by Turku University Hospital:

Primary Outcome Measures:
  • staging accuracy of PET/MRI in bladder cancer [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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:
  • Accuracy of PET/MRI to estimate response to neoadjuvant chemotherapy [ Time Frame: 3 mo ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Accuracy of prognostic biomarkers to estimate response to neoadjuvant chemotherapy. [ Time Frame: 6 mo ] [ Designated as safety issue: No ]
    Accuracy of tissue, blood and urine based biomarkers to estimate response to neoadjuvant chemotherapy is estimated


Estimated Enrollment: 50
Study Start Date: August 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MRI/PET Device: MRI/acetate-PET imaging
Other Names:
  • Philips Ingenuity PET/MR device
  • 11C-acetate as PET-tracer

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01918592

Contacts
Contact: Peter J. Bostrom, MD, PhD +358-2-3135925 peter.bostrom@tyks.fi

Locations
Finland
Helsinki University Hospital Recruiting
Helsinki, Finland
Contact: Ilmari Koskinen, MD       ilmari.koskinen@hus.fi   
Principal Investigator: Ilmari Koskinen, MD         
Tampere University Hospital Recruiting
Tampere, Finland
Contact: Andres Kotsar, MD       andres.kotsar@gmail.com   
Principal Investigator: Andres Kotsar, MD         
Turku University Hospital Recruiting
Turku, Finland, 20100
Contact: Peter Bostrom, MD         
Principal Investigator: Peter Bostrom, MD         
Sponsors and Collaborators
Turku University Hospital
  More Information

No publications provided

Responsible Party: Peter Boström, chief, department of urology, Turku University Hospital
ClinicalTrials.gov Identifier: NCT01918592     History of Changes
Other Study ID Numbers: ACEBIB
Study First Received: August 5, 2013
Last Updated: January 17, 2014
Health Authority: Finland: Ethics Committee

Keywords provided by Turku University Hospital:
bladder cancer
neoadjuvant chemotherapy
radical cystectomy
lymphadenectomy
biomarker

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 16, 2014