Back to resultsPET/MRI and Biomarkers in Bladder Cancer (ACEBIB)
Primary Purpose
Bladder Cancer
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
MRI/acetate-PET imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Bladder Cancer focused on measuring bladder cancer, neoadjuvant chemotherapy, radical cystectomy, lymphadenectomy, biomarker
Eligibility 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
Sites / Locations
- Helsinki University Hospital
- Tampere University Hospital
- Turku University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MRI/PET
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01918592
First Posted
August 5, 2013
Last Updated
April 16, 2018
Sponsor
Turku University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01918592
Brief Title
PET/MRI and Biomarkers in Bladder Cancer
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Turku University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
bladder cancer, neoadjuvant chemotherapy, radical cystectomy, lymphadenectomy, biomarker
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MRI/PET
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
MRI/acetate-PET imaging
Other Intervention Name(s)
Philips Ingenuity PET/MR device, 11C-acetate as PET-tracer
Primary Outcome Measure Information:
Title
staging accuracy of PET/MRI in bladder cancer
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Accuracy of PET/MRI to estimate response to neoadjuvant chemotherapy
Description
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.
Time Frame
3 mo
Other Pre-specified Outcome Measures:
Title
Accuracy of prognostic biomarkers to estimate response to neoadjuvant chemotherapy.
Description
Accuracy of tissue, blood and urine based biomarkers to estimate response to neoadjuvant chemotherapy is estimated
Time Frame
6 mo
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Helsinki University Hospital
City
Helsinki
Country
Finland
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
20100
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
30068379
Citation
Salminen A, Jambor I, Merisaari H, Ettala O, Virtanen J, Koskinen I, Veskimae E, Sairanen J, Taimen P, Kemppainen J, Minn H, Bostrom PJ. 11C-acetate PET/MRI in bladder cancer staging and treatment response evaluation to neoadjuvant chemotherapy: a prospective multicenter study (ACEBIB trial). Cancer Imaging. 2018 Aug 2;18(1):25. doi: 10.1186/s40644-018-0158-4.
Results Reference
derived
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PET/MRI and Biomarkers in Bladder Cancer
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