We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

PET/MRI and Biomarkers in Bladder Cancer (ACEBIB)

This study is currently recruiting participants.
Verified November 2015 by Peter Boström, Turku University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01918592
First Posted: August 8, 2013
Last Update Posted: November 6, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Peter Boström, Turku University Hospital
  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: None (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 Peter Boström, Turku University Hospital:

Primary Outcome Measures:
  • staging accuracy of PET/MRI in bladder cancer [ Time Frame: 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:
  • Accuracy of PET/MRI to estimate response to neoadjuvant chemotherapy [ Time Frame: 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.


Other Outcome Measures:
  • Accuracy of prognostic biomarkers to estimate response to neoadjuvant chemotherapy. [ Time Frame: 6 mo ]
    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: November 2016
Estimated Primary Completion Date: March 2016 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Peter Boström, chief, department of urology, Turku University Hospital
ClinicalTrials.gov Identifier: NCT01918592     History of Changes
Other Study ID Numbers: ACEBIB
First Submitted: August 5, 2013
First Posted: August 8, 2013
Last Update Posted: November 6, 2015
Last Verified: November 2015

Keywords provided by Peter Boström, 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