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New treatment option for Bladder Cancer
Official title Bladder Fiducial Markers and Multiparametric-MRI (Mp-MRI) to Optimize Bladder Chemo-radiotherapy
ClinicalTrials.gov ID: NCT04442724
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Pathologically (histologically or cytologically) proven diagnosis of primary urothelial carcinoma of the bladder. people with mixed histology are...
- 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 \ 30ml/min
- Ability to understand and willingness to sign a written informed consent
You likely can't join if
- people 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)
- people with malignant lymphadenopathy in the abdomen or pelvis considered appropriate for radical cystectomy and lymphadenectomy with the goal of...
- Patients with bladder abnormalities that preclude safe placement of fiducial markers (i.e. abundant large diverticuli or cellules, active or...
- Planned (or prior history of) definitive bladder irradiation
- Intravesical chemo- or biologic therapy within 6 weeks of first treatment
See the full eligibility criteria
- Pathologically (histologically or cytologically) proven diagnosis of primary urothelial carcinoma of the bladder. people 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 \ 30ml/min
- Ability to understand and willingness to sign a written informed consent
- Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, during study participation, and for 90 days after study treatment discontinuation
- Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
- people 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)
- people 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)
- Planned (or prior history of) definitive bladder irradiation
- Intravesical chemo- or biologic therapy within 6 weeks of first treatment
- Any planned neoadjuvant systemic immunotherapy. Note that prior bacille Calmette-Guerin vaccine (BCG) is not an exclusion
- Clinically significant active infection or uncontrolled medical condition that would preclude participation in study
- Pregnant or nursing women are excluded
- Previous malignancy other than TCC that, in the opinion of the treating investigator, is likely to interfere with protocol treatment
- Individuals with severe renal failure and cannot receive MRI contrast
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.