Muscle Invasive Bladder Cancer (MIBC)NCT07026864
MRI-Guided Bladder Preservation Program For Patients With Muscle Invasive Bladder Cancer
A study testing MR-guided Radiation Therapy in people with Muscle Invasive Bladder Cancer (MIBC), run by Clinica Universidad de Navarra, Universidad de Navarra.
Trial summary
The goal of this clinical trial is to learn if the use of MRI-guided irradiation increases the rates of bladder preservation as well as to decrease complications in patients with muscle invasive bladder cancer who wish to retain their bladders Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Invasive Bladder Cancer (MIBC)
- What is being tested?
- MR-guided Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Jul 2030
- 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
- Patients with T2-T3N0M0 unifocal bladder cancer of any histologic subtype except squamous cell carcinoma or adenocarcinoma (Janopaul-Naylor et al., 2021) treated the maximal TURBT and able to tolerate concurrent chemoradiotherapy. Selected patients with high risk of common iliac involvement (T4 disease and/or limited N+ disease and/or LVSI+ status) able to receive the following treatment may be included as well. Additional criteria include:
- Karnofsky performance status > 70 with medical condition not contraindicating treatment with radical intent including maximal TURBT and concomitant chemotherapy;
- WBC equal or greater than 3500 mm3; platelet count equal or greater than 135000 mm3; hemoglobin equal or greater than 10 gr/L; BUN equal or less than 20; serum creatinine equal or less than 2.0.
Who cannot join
- Prior radiation therapy to the target areas;
- Inability to undergo a MRI exam
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
Official title: Project #1: MRI-guided Bladder Cancer Preservation Program
The goal of this clinical trial is to learn if the use of MRI-guided irradiation increases the rates of bladder preservation as well as to decrease complications in patients with muscle invasive bladder cancer who wish to retain their bladders
Read the detailed description
HYPOTHESIS The implementation of Magnetic Resonance Image Guided Radiotherapy (MRgRT) into a Bladder Preservation Program maximizes treatment objectives rates due to the better visualization and online dose-adaptation of the TURBT cavity.
Rationale In the radiation setting, MRI provides superior soft tissue contrast compared to standard onboard X-ray imaging improving inter- and intra- observer delineation variation (Noel et al., 2015). MRgRT offers the opportunity to adapt the plan at each fraction to the anatomical changes seen (Henke et al., 2018). This is especially important in bladder tumors where bladder is subject to large interfractional position changes as well as intrafractional shape and size variation since the on-board median filling rate is close to 2 ml/min. This requires that intrafraction bladder filling has to be successfully accommodated in order to maintain adequate target coverage (Dees-Ribbers et al., 2014). It is hypothesized therefore that MRgRT facilitates tumor boost and partial bladder irradiation approaches (Hafeez et al., 2016; Vestergaard et al., 2016).
MRgRT has been shown to be feasible. Authors reported that the full online adaptive planning workflow based on the anatomy seen at each fraction was delivered within 45 min. Intra-fraction bladder filling did not compromise target coverage. Patients reported acceptable tolerance of treatment (Hunt et al., 2020).
Primary Objectives A. To achieve pathological complete response rate in 95% of the patients. B. To decrease urinary grade 3 or greater toxicity below 3% and rectal grade 3 or greater toxicity below 1%.
Secondary Objectives A. Determination of blood and urine biomarkers of treatment response and toxicity .
- Determination of radiomics biomarkers of treatment response and toxicity . C. Determination of urinary functionality with IPSS and Bladder Control Self-Assessment Questionnaire
- Conditions
- Muscle Invasive Bladder Cancer (MIBC)
- Being tested
- MR-guided Radiation Therapy
- Keywords
- Muscle Invasive Bladder Cancer, Bladder Preservation, Radiation Therapy, MR-Guided Radiation Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-guided Radiation TherapyRadiation
MR-guided Radiation Therapy
| Study group | Role | What they receive |
|---|---|---|
| MRI-guided Bladder Cancer Preservation Program | Experimental | Not described Receives: Radiation: MR-guided Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response rate and Urinary and Rectal Toxicity
- To achieve pathological complete response rate in 95% of the patients. B. To decrease urinary grade 3 or greater toxicity below 3% and rectal grade 3 or greater toxicity below 1%.
Measured: Five years
Secondary outcomes (1)
Blood and urine biomarkers, Radiomics biomarkers and PROMs
- Determination of blood and urine biomarkers of treatment response and toxicity .
- Determination of radiomics biomarkers of treatment response and toxicity . C. Determination of urinary functionality with IPSS and Bladder Control Self-Assessment Questionnaire
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Jul 2030 (estimated)
- Study completion1 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Invasive Bladder Cancer (MIBC)Studies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafael Martínez Monge, Clinica Universidad de Navarra, Universidad de Navarra
- Investigators
- Rafael Martínez-Monge, M.D., Principal investigator, Clinica Universidad de Navarra, Universidad de NavarraMarta Moreno-Jiménez, M.D., Principal investigator, Clinica Universidad de Navarra, Universidad de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026864
- Sponsor's protocol ID
- 2024.110
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: On request
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project #1: MRI-guided Bladder Cancer Preservation Program
- ClinicalTrials.gov ID
- NCT07026864
- Acronym / sponsor ID
- 2024.110
- Conditions
- Muscle Invasive Bladder Cancer (MIBC)
- Keywords
- Muscle Invasive Bladder Cancer, Bladder Preservation, Radiation Therapy, MR-Guided Radiation Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Jul 2030 (estimated)
- Study completion
- 1 Jul 2030 (estimated)
- First posted
- 18 Jun 2025 (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.
The goal of this clinical trial is to learn if the use of MRI-guided irradiation increases the rates of bladder preservation as well as to decrease complications in patients with muscle invasive bladder cancer who wish to retain their bladders
Detailed description
HYPOTHESIS The implementation of Magnetic Resonance Image Guided Radiotherapy (MRgRT) into a Bladder Preservation Program maximizes treatment objectives rates due to the better visualization and online dose-adaptation of the TURBT cavity.
Rationale In the radiation setting, MRI provides superior soft tissue contrast compared to standard onboard X-ray imaging improving inter- and intra- observer delineation variation (Noel et al., 2015). MRgRT offers the opportunity to adapt the plan at each fraction to the anatomical changes seen (Henke et al., 2018). This is especially important in bladder tumors where bladder is subject to large interfractional position changes as well as intrafractional shape and size variation since the on-board median filling rate is close to 2 ml/min. This requires that intrafraction bladder filling has to be successfully accommodated in order to maintain adequate target coverage (Dees-Ribbers et al., 2014). It is hypothesized therefore that MRgRT facilitates tumor boost and partial bladder irradiation approaches (Hafeez et al., 2016; Vestergaard et al., 2016).
MRgRT has been shown to be feasible. Authors reported that the full online adaptive planning workflow based on the anatomy seen at each fraction was delivered within 45 min. Intra-fraction bladder filling did not compromise target coverage. Patients reported acceptable tolerance of treatment (Hunt et al., 2020).
Primary Objectives A. To achieve pathological complete response rate in 95% of the patients. B. To decrease urinary grade 3 or greater toxicity below 3% and rectal grade 3 or greater toxicity below 1%.
Secondary Objectives A. Determination of blood and urine biomarkers of treatment response and toxicity .
- Determination of radiomics biomarkers of treatment response and toxicity . C. Determination of urinary functionality with IPSS and Bladder Control Self-Assessment Questionnaire
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI-guided Bladder Cancer Preservation Program | Experimental | Radiation: MR-guided Radiation Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with T2-T3N0M0 unifocal bladder cancer of any histologic subtype except squamous cell carcinoma or adenocarcinoma (Janopaul-Naylor et al., 2021) treated the maximal TURBT and able to tolerate concurrent chemoradiotherapy. Selected patients with high risk of common iliac involvement (T4 disease and/or limited N+ disease and/or LVSI+ status) able to receive the following treatment may be included as well. Additional criteria include:
- Karnofsky performance status > 70 with medical condition not contraindicating treatment with radical intent including maximal TURBT and concomitant chemotherapy;
- WBC equal or greater than 3500 mm3; platelet count equal or greater than 135000 mm3; hemoglobin equal or greater than 10 gr/L; BUN equal or less than 20; serum creatinine equal or less than 2.0.
Key exclusion criteria (2 listed)
- Prior radiation therapy to the target areas;
- Inability to undergo a MRI exam
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-guided Radiation TherapyMR-guided Radiation Therapy | Radiation | MRI-guided Bladder Cancer Preservation Program |
Primary outcome
Pathological complete response rate and Urinary and Rectal Toxicity
Time frame: Five years
A. To achieve pathological complete response rate in 95% of the patients. B. To decrease urinary grade 3 or greater toxicity below 3% and rectal grade 3 or greater toxicity below 1%.
1 secondary outcome
Blood and urine biomarkers, Radiomics biomarkers and PROMs
Time frame: 5 years
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 24 Aug 2025.
- Individual participant dataSharing planned: Yes. On request
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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.
Rafael Martínez-Monge, M.D. principal investigator
Clinica Universidad de Navarra, Universidad de Navarra
Marta Moreno-Jiménez, M.D. principal investigator
Clinica Universidad de Navarra, Universidad de Navarra
Questions about this trial
What is this clinical trial studying?
A study testing MR-guided Radiation Therapy in people with Muscle Invasive Bladder Cancer (MIBC), run by Clinica Universidad de Navarra, Universidad de Navarra.
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 3 inclusion and 2 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 24 Aug 2025. 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 Beatriz Ramos Aguirre, M.S. (+34 948255400 ext. 2772, ucicec@unav.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response rate and Urinary and Rectal Toxicity (time frame: Five years). 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 24 Aug 2025.