Bladder CancerFMBRTNCT04442724
Bladder Fiducial Markers and Multiparametric-MRI (Mp-MRI) to Optimize Bladder Chemo-radiotherapy
A study testing Fiducial marker placement and Multiparametric MRI (mpMRI) in people with Bladder Cancer and Urinary Bladder Neoplasm, run by Cedars-Sinai Medical Center at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Urinary Bladder Neoplasm, Urologic Neoplasms
- What is being tested?
- Fiducial marker placement and Multiparametric MRI (mpMRI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jul 2020to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- 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)
- Planned (or prior history of) definitive bladder irradiation
- Intravesical chemo- or biologic therapy within 6 weeks of first treatment
Show all 11Show fewer
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Harvard School of Medicine/Massachusetts General Hospital (MGH)
Boston, Massachusetts, 02114
Sarah Stec, SSTEC@mgh.harvard.edu
- Recruiting
Cedars-Sinai Medical Center (CSMC)
Los Angeles, California, 90048
- Recruiting
University of California Los Angeles
Los Angeles, California, 90095
Jackie Hernandez, CCRP, 310-267-8991, jhernandez@mednet.ucla.edu
About this study
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.
Read the detailed description
This study of fiducial markers in patients with localized muscle-invasive bladder cancer will enroll patients electing bladder preservation with tri-modal therapy.
24-K gold fiducial markers will be endoscopically implanted around the tumor resection area to mark the location of the tumor site, into the bladder wall submucosa space under direct visualization via a coaxial needle. The markers are visible on all imaging modalities, including all available on-table imaging (e.g., portal and cone-beam CT) used for radiotherapy. Reliable fiducial marker placement within the bladder may have the potential to advance bladder-sparing management of localized muscle-invasive bladder cancer.
This study will examine the effectiveness of bladder-preserving multi-modal treatment of muscle-invasive bladder cancer with and without fiducial marker placement to guide radiotherapy targeting and to minimize collateral radiation. In addition, this study intends to verify the accuracy and report on the sensitivity and specificity of mp-MRI imaging to detect the presence and location of bladder cancer.
- Conditions
- Bladder Cancer, Urinary Bladder Neoplasm, Urologic Neoplasms, Neoplasms, Urinary Bladder Diseases
- Being tested
- Fiducial marker placement, Multiparametric MRI (mpMRI)
- Keywords
- Fiducial marker, Fiducial marker guided technique
- Medical subject headings
- Urinary Bladder Neoplasms, Urologic Neoplasms, Neoplasms, Urinary Bladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fiducial marker placementProcedure or surgery
placement of 24k gold fiducial markers surrounding the tumor site, at time of primary or re-staging bladder tumor resection
Multiparametric MRI (mpMRI)Diagnostic test
In this study, mp-MRI is defined as MRI that includes T1 \& T2 weighted sequences, diffusion weighted sequences, and Dynamic contrast enhanced (DCE) MRI sequences.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm - Bladder Chemo-Radiotherapy | Experimental | Fiducial marker placement \& cystogram during resection surgery, followed by radiation planning CT scan, mpMRI, chemo-radiation treatment; mpMRI and/or surveillance cystoscopy at 3, 6, and 9 months post-treatment. Receives: Procedure: Fiducial marker placement; Diagnostic Test: Multiparametric MRI (mpMRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, after marker placement (anticipated to occur between study days 0-1)
Secondary outcomes (3)
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
Measured: Baseline, after marker placement (anticipated to occur between study days 0-1)
Positive Predictive Value of Multiparametric-MRI (mp-MRI)
percentage of actual positive sites among those predicted positive by mpMRI
Measured: at the time of initial TURBT (Day 1), at the initial post-treatment surveillance cystoscopy (3 months post-treatment)
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.
Measured: Radiotherapy treatment period (Days 14-28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start1 Jul 2020
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Maurice M. Garcia, Cedars-Sinai Medical Center
- Investigators
- Maurice Garcia, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442724
- Sponsor's protocol ID
- IIT2017-12-Garcia-FMBRT
- Other IDs
- 1R01CA201709-01
- Acronym
- FMBRT
- Status last verified
- Aug 2025
- First submitted
- 18 Jun 2020
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bladder Fiducial Markers and Multiparametric-MRI (Mp-MRI) to Optimize Bladder Chemo-radiotherapy
- ClinicalTrials.gov ID
- NCT04442724
- Acronym / sponsor ID
- FMBRT / IIT2017-12-Garcia-FMBRT
- Conditions
- Bladder Cancer, Urinary Bladder Neoplasm, Urologic Neoplasms, Neoplasms, Urinary Bladder Diseases
- Keywords
- Fiducial marker, Fiducial marker guided technique
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 23 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study of fiducial markers in patients with localized muscle-invasive bladder cancer will enroll patients electing bladder preservation with tri-modal therapy.
24-K gold fiducial markers will be endoscopically implanted around the tumor resection area to mark the location of the tumor site, into the bladder wall submucosa space under direct visualization via a coaxial needle. The markers are visible on all imaging modalities, including all available on-table imaging (e.g., portal and cone-beam CT) used for radiotherapy. Reliable fiducial marker placement within the bladder may have the potential to advance bladder-sparing management of localized muscle-invasive bladder cancer.
This study will examine the effectiveness of bladder-preserving multi-modal treatment of muscle-invasive bladder cancer with and without fiducial marker placement to guide radiotherapy targeting and to minimize collateral radiation. In addition, this study intends to verify the accuracy and report on the sensitivity and specificity of mp-MRI imaging to detect the presence and location of bladder cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm - Bladder Chemo-Radiotherapy | Experimental | Procedure: Fiducial marker placement, Diagnostic Test: Multiparametric MRI (mpMRI)Fiducial marker placement \& cystogram during resection surgery, followed by radiation planning CT scan, mpMRI, chemo-radiation treatment; mpMRI and/or surveillance cystoscopy at 3, 6, and 9 months post-treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- Ability to understand and willingness to sign a written informed consent
Key exclusion criteria (11 listed)
- 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)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fiducial marker placementplacement of 24k gold fiducial markers surrounding the tumor site, at time of primary or re-staging bladder tumor resection | Procedure or surgery | Single Arm - Bladder Chemo-Radiotherapy |
| Multiparametric MRI (mpMRI)In this study, mp-MRI is defined as MRI that includes T1 \& T2 weighted sequences, diffusion weighted sequences, and Dynamic contrast enhanced (DCE) MRI sequences. | Diagnostic test | Single Arm - Bladder Chemo-Radiotherapy |
Primary outcome
Bladder volume differential
Time frame: Baseline, after marker placement (anticipated to occur between study days 0-1)
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
3 secondary outcomes
Net dose radiation to collateral organs differential
Time frame: Baseline, after marker placement (anticipated to occur between study days 0-1)
Positive Predictive Value of Multiparametric-MRI (mp-MRI)
Time frame: at the time of initial TURBT (Day 1), at the initial post-treatment surveillance cystoscopy (3 months post-treatment)
Difference in alignment when markers are incorporated into the planning
Time frame: Radiotherapy treatment period (Days 14-28)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maurice Garcia, MD principal investigator
Cedars-Sinai Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fiducial marker placement and Multiparametric MRI (mpMRI) in people with Bladder Cancer and Urinary Bladder Neoplasm, run by Cedars-Sinai Medical Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Sarmiento, CCRP (310-423-4295, laura.sarmiento@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bladder volume differential (time frame: Baseline, after marker placement (anticipated to occur between study days 0-1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.