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Search / Trial NCT07026864

MRI-Guided Bladder Preservation Program For Patients With Muscle Invasive Bladder Cancer

Launched by CLINICA UNIVERSIDAD DE NAVARRA, UNIVERSIDAD DE NAVARRA · Jun 10, 2025

Trial Information

Current as of July 27, 2025

Not yet recruiting

Keywords

Muscle Invasive Bladder Cancer Bladder Preservation Radiation Therapy Mr Guided Radiation Therapy

ClinConnect Summary

This clinical trial is studying a new way to treat muscle invasive bladder cancer (MIBC) that aims to preserve the bladder, rather than removing it. The researchers want to find out if using MRI scans to guide radiation treatment can help more patients keep their bladders and reduce side effects or complications from the treatment. This approach could offer an option for patients who prefer to avoid surgery that removes the bladder.

Patients who might be eligible for this trial are adults with a specific type of bladder cancer (called T2-T3N0M0) that affects one area of the bladder and who have already had a procedure to remove as much tumor as possible. They must be healthy enough to receive combined chemotherapy and radiation therapy and able to have an MRI scan. People with certain types of bladder cancer, prior radiation to the area, or serious health problems would not qualify. If accepted, participants would receive carefully targeted radiation treatment guided by MRI to try and preserve bladder function while treating the cancer. This trial is not yet open for enrollment but aims to offer a promising option for bladder cancer patients who want to keep their bladder.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. 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:
  • 2. Karnofsky performance status \> 70 with medical condition not contraindicating treatment with radical intent including maximal TURBT and concomitant chemotherapy;
  • 3. 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.
  • Exclusion Criteria:
  • 1. Prior radiation therapy to the target areas;
  • 2. Inability to undergo a MRI exam

About Clinica Universidad De Navarra, Universidad De Navarra

Clinica Universidad de Navarra, affiliated with Universidad de Navarra, is a leading academic medical center dedicated to advancing healthcare through innovative clinical research and patient care. With a commitment to excellence, it integrates cutting-edge medical research with comprehensive clinical services, fostering an environment that promotes the development of new therapies and treatment protocols. The institution is recognized for its robust clinical trial programs, which aim to enhance patient outcomes and contribute to the global medical community's knowledge. Through collaboration with various research entities and a focus on ethical standards, Clinica Universidad de Navarra plays a pivotal role in translating scientific discoveries into practical applications in medicine.

Locations

Patients applied

0 patients applied

Trial Officials

Rafael Martínez-Monge, M.D.

Principal Investigator

Clínica Universidad de Navarra

Marta Moreno-Jiménez, M.D.

Principal Investigator

Clínica Universidad de Navarra

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported