Bladder Fiducial Markers and Multiparametric-MRI (Mp-MRI) to Optimize Bladder Chemo-radiotherapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCedars-Sinai Medical Center
About this trial
The purpose of this study is to examine the usefulness of implanting small 24-K gold fiducial markers around a bladder tumor site, so that a Radiation Oncologist can identify the original tumor location at the time of radiation treatment. Other goals of the study include assessing whether a new MRI imaging technology can help with detection of bladder cancer earlier and more accurately when evidence of bladder cancer is not visible by scope.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pathologically (histologically or cytologically) proven diagnosis of primary urothelial carcinoma of the bladder. Subjects with mixed histology are required to have a dominant traditional cell carcinoma (TCC) pattern.
Clinical stage T2-T4a, Nx, M0 considered appropriate for, and electing to receive, chemoradiation of the bladder
Planned TURBT as part of the normal course treatment, to take place prior to the initiation of chemo irradiation
Adequate renal function: Serum creatinine < 2 mg/dL OR calculated creatinine clearance (CrCl) > 30ml/min
Disqualifiers
Subjects with primary TCC of the ureter, urethra, or renal pelvis, without TCC of the bladder, are not allowed
Known distant metastatic disease (e.g. pulmonary or hepatic metastases)
Subjects with malignant lymphadenopathy in the abdomen or pelvis considered appropriate for radical cystectomy and lymphadenectomy with the goal of complete resection of all malignant disease are allowed
Patients with bladder abnormalities that preclude safe placement of fiducial markers (i.e. abundant large diverticuli or cellules, active or recurrent urinary infection)
Trial design
Design model
Single group
Treatments tested in this trial
Fiducial marker placement
Procedure/Surgeryplacement of 24k gold fiducial markers surrounding the tumor site, at time of primary or re-staging bladder tumor resection
Multiparametric MRI (mpMRI)
Diagnostic testIn this study, mp-MRI is defined as MRI that includes T1 \& T2 weighted sequences, diffusion weighted sequences, and Dynamic contrast enhanced (DCE) MRI sequences.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Single Arm - Bladder Chemo-RadiotherapyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Bladder volume differential
Change in bladder volumes targeted for high dose radiation (HDR) between the first (Baseline) dose volume histogram (DVH) without the fiducial markers present, compared to the second DVH made after placement of the fiducial markers
Time frame
Baseline, after marker placement (anticipated to occur between study days 0-1)Secondary outcomes
1
Net dose radiation to collateral organs differential
comparison of a DVH (Dose Volume Histogram) made without the fiducial markers present, to the second DVH made with the fiducial markers present. This will be measured by net dose (Gy to area and/or volume) to collateral organs
Time frame
Baseline, after marker placement (anticipated to occur between study days 0-1)2
Positive Predictive Value of Multiparametric-MRI (mp-MRI)
percentage of actual positive sites among those predicted positive by mpMRI
Time frame
at the time of initial TURBT (Day 1), at the initial post-treatment surveillance cystoscopy (3 months post-treatment)3
Difference in alignment when markers are incorporated into the planning
Difference in "on-table" patient alignment under the radiotherapy gantry (in millimeters, in X, Y and Z dimensions) when the patient is aligned daily based on conventional methods only (i.e. fiducial markers are not used for alignment), and when the patient is aligned based on the fiducial markers as the reference.
Time frame
Radiotherapy treatment period (Days 14-28)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Cedars-Sinai Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov