Bladder CancerMIBNCT02662166
MRI in Clinical Staging and Estimation of Treatment Response in Bladder Cancer
A study testing MR imaging in people with Bladder Cancer, run by Turku University Hospital at 2 sites in Finland.
Trial summary
Bladder cancer (BC) as the most common malignancy arising from the urinary tract continues to be a major health problem. This prospective non-randomized study will enroll 150 patients undergoing magnetic resonance imaging (MRI) at different stages of their diagnostic and therapeutical process. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- MR imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesFinland
- Study dates
- Jul 2014to 1 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 to 85 years old
- Suspected BC based on cystoscopical evaluation.
- 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
Who cannot join
- History of serious cardiovascular, liver or kidney disease
- Uncontrolled serious infection
- Contraindications for MRI (cardiac pacemaker, intracranial clips etc)
- Patient refusing radical cystectomy or chemotherapy or BCG
- Intravesical Bacillus Calmette-Guerin instillations within 6 months before the first MRI examination
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Department of Urology, Central Hospital of Pori
Pori
University of Turku
Turku, 20100
About this study
Official title: Magnetic Resonance Imaging of Bladder Cancer
Bladder cancer (BC) as the most common malignancy arising from the urinary tract continues to be a major health problem. This prospective non-randomized study will enroll 150 patients undergoing magnetic resonance imaging (MRI) at different stages of their diagnostic and therapeutical process. The enrolled patients with suspected BC (BC) based on cystoscopy will have their initial MRI examination before transurethral resection of bladder tumor (TUR-BT) and biomarker collection. After pathology review of the histological specimens, patients will be treated according to standard clinical practice. The second MRI examination will be performed before therapeutic intervention, if TUR-BT alone is not sufficient enough. Neoadjuvant chemotherapy will be applied in high risk patients having muscle invasison, while intermediate risk patient - T1 high grade or carcinoma in situ patients - will be treated using Bacillus Calmette-Guerin (BCG) instilliations. After the completion of the neoadjuvant chemotherapy or BCG treatment, the patients will undergo the third MRI examination. Low risk patients will be followed by annual with MRI examination.
- Conditions
- Bladder Cancer
- Being tested
- MR imaging
- Keywords
- bladder cancer, MRI, TUR-BT, cystectomy, chemotherapy
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR imagingDevice
3 T MRI of the urinary bladder
| Study group | Role | What they receive |
|---|---|---|
| MRI and biomarkers in bladder cancer | Experimental | Utilization of MR-imaging and biomarkers to stage bladder cancer and in estimation of chemosensitivity Receives: Device: MR imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the multiparametric MRI (anatomical MRI, DCE-MRI, DWI) in the staging of bladder cancer
The accuracy of multiparametric MRI (anatomical MRI, DCE-MRI, DWI) in the staging of bladder cancer will be evaluated using transurethral resection of bladder tumor and cystectomy specimens
Measured: 24 months
Secondary outcomes (1)
Prediction of response to neo-adjuvant chemotherapy and/or BCG treatment evaluated by multiparametric MRI (anatomical MRI, DCE-MRI, DWI)
The aim is to evaluate predictive power of multiparametric MRI for estimation neo-adjuvant chemotherapy and/or BCG treatment response. Multiparametric MRI will be performed before neo-adjuvant chemotherapy and/or BCG treatment and patients will be followed using standard clinical follow up and/or undergo cystectomy.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2016 (estimated)
- Study startJul 2014
- Primary completion10 Jul 2019
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Peter Boström, Turku University Hospital
- Investigators
- Peter Boström, MD, PhD, Principal investigator, Department of Urology, University of Turku and Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02662166
- Sponsor's protocol ID
- 6/1801/2014
- Acronym
- MIB
- Status last verified
- Jun 2020
- First submitted
- 5 Jan 2015
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Nikulainen I, Salminen AP, Jambor I, Merisaari H, Tammilehto V, Taimen P, Seikkula H, Bostrom PJ. Visual MRI T-category versus VI-RADS evaluation from multiparametric MRI in the detection of muscle-invasion in patients with suspected bladder cancer: single centre registered clinical trial (MIB-trial). Scand J Urol. 2021 Oct;55(5):354-360. doi: 10.1080/21681805.2021.1971290. Epub 2021 Aug 27.
PubMed 34448679
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging of Bladder Cancer
- ClinicalTrials.gov ID
- NCT02662166
- Acronym / sponsor ID
- MIB / 6/1801/2014
- Conditions
- Bladder Cancer
- Keywords
- bladder cancer, MRI, TUR-BT, cystectomy, chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- Jul 2014 (actual)
- Primary completion
- 10 Jul 2019 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 25 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bladder cancer (BC) as the most common malignancy arising from the urinary tract continues to be a major health problem. This prospective non-randomized study will enroll 150 patients undergoing magnetic resonance imaging (MRI) at different stages of their diagnostic and therapeutical process. The enrolled patients with suspected BC (BC) based on cystoscopy will have their initial MRI examination before transurethral resection of bladder tumor (TUR-BT) and biomarker collection. After pathology review of the histological specimens, patients will be treated according to standard clinical practice. The second MRI examination will be performed before therapeutic intervention, if TUR-BT alone is not sufficient enough. Neoadjuvant chemotherapy will be applied in high risk patients having muscle invasison, while intermediate risk patient - T1 high grade or carcinoma in situ patients - will be treated using Bacillus Calmette-Guerin (BCG) instilliations. After the completion of the neoadjuvant chemotherapy or BCG treatment, the patients will undergo the third MRI examination. Low risk patients will be followed by annual with MRI examination.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI and biomarkers in bladder cancer | Experimental | Device: MR imagingUtilization of MR-imaging and biomarkers to stage bladder cancer and in estimation of chemosensitivity |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 18 to 85 years old
- Suspected BC based on cystoscopical evaluation.
- 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
Key exclusion criteria (5 listed)
- History of serious cardiovascular, liver or kidney disease
- Uncontrolled serious infection
- Contraindications for MRI (cardiac pacemaker, intracranial clips etc)
- Patient refusing radical cystectomy or chemotherapy or BCG
- Intravesical Bacillus Calmette-Guerin instillations within 6 months before the first MRI examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR imaging3 T MRI of the urinary bladder | Device | MRI and biomarkers in bladder cancer |
Primary outcome
Accuracy of the multiparametric MRI (anatomical MRI, DCE-MRI, DWI) in the staging of bladder cancer
Time frame: 24 months
The accuracy of multiparametric MRI (anatomical MRI, DCE-MRI, DWI) in the staging of bladder cancer will be evaluated using transurethral resection of bladder tumor and cystectomy specimens
1 secondary outcome
Prediction of response to neo-adjuvant chemotherapy and/or BCG treatment evaluated by multiparametric MRI (anatomical MRI, DCE-MRI, DWI)
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Derived from this study: PubMed 34448679Nikulainen I, Salminen AP, Jambor I, Merisaari H, Tammilehto V, Taimen P, Seikkula H, Bostrom PJ. Visual MRI T-category versus VI-RADS evaluation from multiparametric MRI in the detection of muscle-invasion in patients with suspected bladder cancer: single centre registered clinical trial (MIB-trial). Scand J Urol. 2021 Oct;55(5):354-360. doi: 10.1080/21681805.2021.1971290. Epub 2021 Aug 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Boström, MD, PhD principal investigator
Department of Urology, University of Turku and Turku University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR imaging in people with Bladder Cancer, run by Turku University Hospital at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the multiparametric MRI (anatomical MRI, DCE-MRI, DWI) in the staging of bladder cancer (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02662166, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2020.