This study focuses on individuals who have been diagnosed with muscle-invasive bladder cancer and are considering bladder-preserving treatment with a combination of maximal tumor resection, chemotherapy and radiation therapy. The purpose of the study is to examine the usefulness of implanting small (3 mm. x 1 mm.), 24-karat gold fiducial markers around the tumor site in the patient’s bladder so that the radiation oncologist can identify the original location of the patient’s tumor each day that they treat the bladder with radiation. The gold fiducial markers can generally be seen clearly during radiation treatment and are considered the best practice. These markers are used because the tumor site often does not show up well with conventional imaging during radiation treatment. Researchers will follow participants’ medical outcomes to determine whether implanting the markers improves how accurately the bladder/tumor site can be targeted (thereby avoiding radiation of organs or areas that should not be radiated). Other goals of the study include assessing whether an imaging technology called mpMRI (high-resolution multi-parametric MRI) can help detect bladder cancer earlier and more accurately when evidence of bladder cancer is not visible by scope. Additionally, researchers will explore whether mpMRI can distinguish between tumor recurrence versus scar-tissue in the bladder that can look like a tumor among patients who have already had radiation treatment and are now undergoing post-treatment follow-up imaging (“cancer surveillance”).
What is the full name of this clinical trial?
IIT2017-12-GARCIA-FMBRT: Bladder Fiducial Markers and Multi-parametric-MRI to Optimize Bladder Chemo-radiotherapy