Bladder CancerACEBIBNCT01918592
PET/MRI and Biomarkers in Bladder Cancer
A study testing MRI/acetate-PET imaging in people with Bladder Cancer, run by Turku University Hospital at 3 sites in Finland.
Trial 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. 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?
- MRI/acetate-PET imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesFinland
- Study dates
- Aug 2013to Nov 2016
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Finland3 sites
Helsinki University Hospital
Helsinki
Tampere University Hospital
Tampere
Turku University Hospital
Turku, 20100
About this study
Official title: PET/MRI and Biomarkers in Clinical Staging of Bladder Cancer and in the Estimation of Neoadjuvant Chemotherapy Response Prior to Radical Cystectomy
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.
- Conditions
- Bladder Cancer
- Being tested
- MRI/acetate-PET imaging
- Keywords
- bladder cancer, neoadjuvant chemotherapy, radical cystectomy, lymphadenectomy, biomarker
- 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.
MRI/acetate-PET imagingDevice
Also called Philips Ingenuity PET/MR device, 11C-acetate as PET-tracer
| Study group | Role | What they receive |
|---|---|---|
| MRI/PET | Experimental | Not described Receives: Device: MRI/acetate-PET imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
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.
Measured: 3 mo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionMar 2016
- Study completionNov 2016
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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Peter Boström, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918592
- Sponsor's protocol ID
- ACEBIB
- Acronym
- ACEBIB
- Status last verified
- Apr 2018
- First submitted
- 5 Aug 2013
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30068379
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET/MRI and Biomarkers in Clinical Staging of Bladder Cancer and in the Estimation of Neoadjuvant Chemotherapy Response Prior to Radical Cystectomy
- ClinicalTrials.gov ID
- NCT01918592
- Acronym / sponsor ID
- ACEBIB / ACEBIB
- Conditions
- Bladder Cancer
- Keywords
- bladder cancer, neoadjuvant chemotherapy, radical cystectomy, lymphadenectomy, biomarker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- Aug 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 8 Aug 2013 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI/PET | Experimental | Device: MRI/acetate-PET imaging |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| MRI/acetate-PET imagingAlso: Philips Ingenuity PET/MR device, 11C-acetate as PET-tracer | Device | MRI/PET |
Primary outcome
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.
1 secondary outcome
Accuracy of PET/MRI to estimate response to neoadjuvant chemotherapy
Time frame: 3 mo
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 18 Apr 2018.
- Derived from this study: PubMed 30068379Salminen 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.
Related trials for Bladder Cancer
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI/acetate-PET imaging in people with Bladder Cancer, run by Turku University Hospital at 3 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 5 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 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
staging accuracy of PET/MRI in bladder cancer (time frame: 3 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 NCT01918592, 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 18 Apr 2018; AzTrials last refreshed its copy on 7 Nov 2026.