Urinary Bladder CancerSMART-BCNCT07924046
Diagnostic Performance of Multiparametric Magnetic Resonance Imaging After Transurethral Resection of Bladder Tumour for Prediction of Muscle Invasion and Detection of Residual Tumour in Non-muscle-invasive Bladder Cancer Patients
A study testing Multiparametric Magnetic Resonance Imaging of the Bladder in people with Urinary Bladder Cancer and NMIBC, run by University of Lausanne Hospitals.
Trial summary
SMART-BC is a prospective, single-centre clinical investigation evaluating the diagnostic performance of multiparametric magnetic resonance imaging (mpMRI) for detecting residual bladder tumour and predicting muscle invasion in patients with non-muscle-invasive bladder cancer (NMIBC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder Cancer, NMIBC, TURBT
- What is being tested?
- Multiparametric Magnetic Resonance Imaging of the Bladder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients with bladder lesion at cystoscopy and indication for a TURBT, and with a urinary cytology positive or suspicious for atypia or high grade (HG) urothelial carcinoma .
- Informed Consent signed by the subject
Who cannot join
- Cystoscopic assessment suspicious for MIBC, or prior cross-sectional imaging-such as CT-demonstrating extra bladder extension (e.g., cT3-T4)
- Pregnancy
- MRI contrast agent precaution
- MRI contraindication (including severe claustrophobia and metallic material presence)
- Patients with hip prosthesis (to avoid non diagnostic MRI examination due to metal artifacts)
- Any other condition making the patient unsuitable for the study
- Patient's refusal of transmission of relevant medical conditions found on the medical examinations performed during the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
SMART-BC is a prospective, single-centre clinical investigation evaluating the diagnostic performance of multiparametric magnetic resonance imaging (mpMRI) for detecting residual bladder tumour and predicting muscle invasion in patients with non-muscle-invasive bladder cancer (NMIBC).
The study comprises two work packages. WP1 will include 20 healthy volunteers to optimize the bladder MRI protocol using additional clinical sequences without contrast injection, assessing image quality through quantitative and qualitative metrics. WP2 will enrol up to 66 patients with newly diagnosed bladder lesions and suspicious or high-grade urinary cytology, aiming to obtain 33 evaluable patients who undergo pre- and post-transurethral resection of bladder tumour (TURBT) MRI and repeat TURBT (re-TURBT), when clinically indicated.
Read more
In WP2, mpMRI will be performed before initial TURBT and approximately 3-4 weeks afterwards in patients requiring re-TURBT. Diagnostic performance will be assessed using sensitivity, specificity, positive predictive value and negative predictive value, with histopathology as the reference standard. Standard VI-RADS sequences will be compared with an optimized protocol incorporating additional sequences. Secondary objectives include inter-reader agreement, patient-reported comfort and satisfaction, and preliminary evaluation of healthcare costs and the potential to avoid unnecessary re-TURBT procedures. Safety will be assessed through the systematic collection of adverse events, serious adverse events and device deficiencies.
The investigation uses CE-marked 3T MRI systems and follows routine clinical management pathways. Its long-term aim is to determine whether post-TURBT mpMRI can improve diagnostic assessment and support more personalized management of patients with high-risk NMIBC.
- Conditions
- Urinary Bladder Cancer, NMIBC, TURBT, Vi-Rads
- Being tested
- Multiparametric Magnetic Resonance Imaging of the Bladder
- Keywords
- Bladder cancer, Non-muscle-invasive bladder cancer, Magnetic resonance imaging, Multiparametric magnetic resonance imaging, Residual tumour, Muscle invasion, Transurethral resection of bladder tumour, Diagnostic accuracy, Bladder cancer staging, Repeat transurethral resection of bladder tumour
- Medical subject headings
- Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiparametric Magnetic Resonance Imaging of the BladderDiagnostic test
Bladder magnetic resonance imaging performed using a 3T MRI system, including standard VI-RADS sequences and additional optimized sequences. Imaging is performed before initial transurethral resection and, when clinically indicated, before repeat resection. The study evaluates image quality and the diagnostic performance of magnetic resonance imaging for detecting residual bladder tumour and predicting muscle invasion.
| Study group | Role | What they receive |
|---|---|---|
| Multiparametric Magnetic Resonance Imaging | Experimental | Participants with suspected bladder cancer will undergo multiparametric magnetic resonance imaging before transurethral resection of bladder tumour. Patients requiring repeat resection according to clinical indications will undergo a second magnetic resonance imaging examination approximately 3-4 weeks after the initial resection. Imaging findings will be compared with histopathological results to assess diagnostic performance. Receives: Diagnostic Test: Multiparametric Magnetic Resonance Imaging of the Bladder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Performance
Diagnostic accuracy metrics (sensitivity, specificity, positive predictive value [PPV], and negative predictive value [NPV]) of mpMRI performed 3-4 weeks after initial TURBT for detecting residual bladder tumour, using histopathology as the reference standard.
Measured: Approximately 3-4 weeks after initial transurethral resection, before repeat resection when clinically indicated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2026
- Study startDec 2026 (estimated)
- Primary completion3 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder CancerStudies of the same condition, open and under way.
- 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
- Model description
- This is a prospective, single-centre, non-randomized diagnostic clinical investigation consisting of two work packages. Work Package 1 will include 20 healthy volunteers to optimize the bladder magnetic resonance imaging protocol and assess image quality. Work Package 2 will include up to 66 patients with newly diagnosed bladder lesions and suspicious or high-grade urinary cytology, with the aim of obtaining 33 evaluable patients. Participants will undergo multiparametric magnetic resonance imaging before transurethral resection of bladder tumour. Patients requiring repeat transurethral resection according to clinical indications will undergo a second magnetic resonance imaging examination approximately 3-4 weeks after the initial procedure. There is no randomization or allocation to treatment groups. All procedures are performed according to the study protocol and routine clinical management. Diagnostic performance will be evaluated by comparing magnetic resonance imaging findings
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naik Vietti Violi, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07924046
- Sponsor's protocol ID
- 2026-D0029
- Acronym
- SMART-BC
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 9 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of Multiparametric Magnetic Resonance Imaging After Transurethral Resection of Bladder Tumour for Prediction of Muscle Invasion and Detection of Residual Tumour in Non-muscle-invasive Bladder Cancer Patients
- ClinicalTrials.gov ID
- NCT07924046
- Acronym / sponsor ID
- SMART-BC / 2026-D0029
- Conditions
- Urinary Bladder Cancer, NMIBC, TURBT, Vi-Rads
- Keywords
- Bladder cancer, Non-muscle-invasive bladder cancer, Magnetic resonance imaging, Multiparametric magnetic resonance imaging, Residual tumour, Muscle invasion, Transurethral resection of bladder tumour, Diagnostic accuracy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- 3 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 9 Nov 2026 (actual)
- 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.
SMART-BC is a prospective, single-centre clinical investigation evaluating the diagnostic performance of multiparametric magnetic resonance imaging (mpMRI) for detecting residual bladder tumour and predicting muscle invasion in patients with non-muscle-invasive bladder cancer (NMIBC).
The study comprises two work packages. WP1 will include 20 healthy volunteers to optimize the bladder MRI protocol using additional clinical sequences without contrast injection, assessing image quality through quantitative and qualitative metrics. WP2 will enrol up to 66 patients with newly diagnosed bladder lesions and suspicious or high-grade urinary cytology, aiming to obtain 33 evaluable patients who undergo pre- and post-transurethral resection of bladder tumour (TURBT) MRI and repeat TURBT (re-TURBT), when clinically indicated.
In WP2, mpMRI will be performed before initial TURBT and approximately 3-4 weeks afterwards in patients requiring re-TURBT. Diagnostic performance will be assessed using sensitivity, specificity, positive predictive value and negative predictive value, with histopathology as the reference standard. Standard VI-RADS sequences will be compared with an optimized protocol incorporating additional sequences. Secondary objectives include inter-reader agreement, patient-reported comfort and satisfaction, and preliminary evaluation of healthcare costs and the potential to avoid unnecessary re-TURBT procedures. Safety will be assessed through the systematic collection of adverse events, serious adverse events and device deficiencies.
The investigation uses CE-marked 3T MRI systems and follows routine clinical management pathways. Its long-term aim is to determine whether post-TURBT mpMRI can improve diagnostic assessment and support more personalized management of patients with high-risk NMIBC.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, single-centre, non-randomized diagnostic clinical investigation consisting of two work packages. Work Package 1 will include 20 healthy volunteers to optimize the bladder magnetic resonance imaging protocol and assess image quality. Work Package 2 will include up to 66 patients with newly diagnosed bladder lesions and suspicious or high-grade urinary cytology, with the aim of obtaining 33 evaluable patients. Participants will undergo multiparametric magnetic resonance imaging before transurethral resection of bladder tumour. Patients requiring repeat transurethral resection according to clinical indications will undergo a second magnetic resonance imaging examination approximately 3-4 weeks after the initial procedure. There is no randomization or allocation to treatment groups. All procedures are performed according to the study protocol and routine clinical management. Diagnostic performance will be evaluated by comparing magnetic resonance imaging findings
| Arm | Type | Receives |
|---|---|---|
| Multiparametric Magnetic Resonance Imaging | Experimental | Diagnostic Test: Multiparametric Magnetic Resonance Imaging of the BladderParticipants with suspected bladder cancer will undergo multiparametric magnetic resonance imaging before transurethral resection of bladder tumour. Patients requiring repeat resection according to clinical indications will undergo a second magnetic resonance imaging examination approximately 3-4 weeks after the initial resection. Imaging findings will be compared with histopathological results to assess diagnostic performance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All adult patients with bladder lesion at cystoscopy and indication for a TURBT, and with a urinary cytology positive or suspicious for atypia or high grade (HG) urothelial carcinoma .
- Informed Consent signed by the subject
Key exclusion criteria (7 listed)
- Cystoscopic assessment suspicious for MIBC, or prior cross-sectional imaging-such as CT-demonstrating extra bladder extension (e.g., cT3-T4)
- Pregnancy
- MRI contrast agent precaution
- MRI contraindication (including severe claustrophobia and metallic material presence)
- Patients with hip prosthesis (to avoid non diagnostic MRI examination due to metal artifacts)
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 |
|---|---|---|
| Multiparametric Magnetic Resonance Imaging of the BladderBladder magnetic resonance imaging performed using a 3T MRI system, including standard VI-RADS sequences and additional optimized sequences. Imaging is performed before initial transurethral resection and, when clinically indicated, before repeat resection. The study evaluates image quality and the diagnostic performance of magnetic resonance imaging for detecting residual bladder tumour and predicting muscle invasion. | Diagnostic test | Multiparametric Magnetic Resonance Imaging |
Primary outcome
Diagnostic Performance
Time frame: Approximately 3-4 weeks after initial transurethral resection, before repeat resection when clinically indicated.
Diagnostic accuracy metrics (sensitivity, specificity, positive predictive value [PPV], and negative predictive value [NPV]) of mpMRI performed 3-4 weeks after initial TURBT for detecting residual bladder tumour, using histopathology as the reference standard.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Multiparametric Magnetic Resonance Imaging of the Bladder in people with Urinary Bladder Cancer and NMIBC, run by University of Lausanne Hospitals.
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 2 inclusion and 7 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: opening soon, as of the sponsor's last update on 9 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naïk NVV Vietti-Violi, Médecin asscoiée (+41 79 556 02 40, Naik.Vietti-Violi@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Performance (time frame: Approximately 3-4 weeks after initial transurethral resection, before repeat resection when clinically indicated.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2026.