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PET/MRI and Biomarkers in Bladder Cancer (ACEBIB)

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ClinicalTrials.gov Identifier: NCT01918592
Recruitment Status : Completed
First Posted : August 8, 2013
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Peter Boström, 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.


Condition or disease Intervention/treatment Phase
Bladder Cancer Device: MRI/acetate-PET imaging Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
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
Study Start Date : August 2013
Actual Primary Completion Date : March 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: MRI/PET Device: MRI/acetate-PET imaging
Other Names:
  • Philips Ingenuity PET/MR device
  • 11C-acetate as PET-tracer



Primary Outcome Measures :
  1. 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 :
  1. 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:
  1. 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



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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

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


Locations
Finland
Helsinki University Hospital
Helsinki, Finland
Tampere University Hospital
Tampere, Finland
Turku University Hospital
Turku, Finland, 20100
Sponsors and Collaborators
Turku University Hospital

Responsible Party: Peter Boström, chief, department of urology, Turku University Hospital
ClinicalTrials.gov Identifier: NCT01918592     History of Changes
Other Study ID Numbers: ACEBIB
First Posted: August 8, 2013    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018

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