Study of Gold Fiducial Markers and Multiparametric MRI to Improve Bladder Cancer Chemo-Radiotherapy

What this Trial Is About

Researchers are evaluating the use of small 24-karat gold fiducial markers implanted around bladder tumor sites in patients with localized muscle-invasive bladder cancer. The study aims to help radiation oncologists accurately identify the original tumor location during radiation treatment. Additionally, the trial examines whether a new multiparametric MRI mp-MRI technique can detect bladder cancer earlier and more precisely when it is not visible by scope. Participants will undergo placement of fiducial markers endoscopically around the tumor resection area into the bladder wall submucosa using a coaxial needle. These markers are visible on various imaging methods, including portal and cone-beam CT used during radiotherapy. The study involves bladder preservation with tri-modal therapy, including chemo-radiation guided by these markers and imaging. Follow-up includes mp-MRI andor surveillance cystoscopy at 3, 6, and 9 months after treatment. During the study, participants will have assessments such as bladder volume measurements before and after marker placement, radiation dose evaluations, and imaging accuracy checks with mp-MRI at initial tumor resection and post-treatment. Researchers will monitor alignment improvements during radiotherapy and evaluate the sensitivity and specificity of mp-MRI for bladder cancer detection. Participant involvement includes imaging, cystoscopy, and chemo-radiation treatments over several months, with safety and treatment effectiveness carefully observed throughout the study period.

Bladder Fiducial Markers and Multiparametric-MRI (Mp-MRI) to Optimize Bladder Chemo-radiotherapy