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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04442724
Other study ID # IIT2017-12-Garcia-FMBRT
Secondary ID 1R01CA201709-01
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2020
Est. completion date August 2024

Study information

Verified date September 2023
Source Cedars-Sinai Medical Center
Contact Laura Sarmiento, CCRP
Phone 310-423-4295
Email laura.sarmiento@cshs.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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 - 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

Study Design


Intervention

Procedure:
Fiducial marker placement
placement of 24k gold fiducial markers surrounding the tumor site, at time of primary or re-staging bladder tumor resection
Diagnostic Test:
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.

Locations

Country Name City State
United States Harvard School of Medicine/Massachusetts General Hospital (MGH) Boston Massachusetts
United States Cedars-Sinai Medical Center (CSMC) Los Angeles California
United States University of California Los Angeles Los Angeles California

Sponsors (2)

Lead Sponsor Collaborator
Cedars-Sinai Medical Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Baseline, after marker placement (anticipated to occur between study days 0-1)
Secondary 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 Baseline, after marker placement (anticipated to occur between study days 0-1)
Secondary Positive Predictive Value of Multiparametric-MRI (mp-MRI) percentage of actual positive sites among those predicted positive by mpMRI at the time of initial TURBT (Day 1), at the initial post-treatment surveillance cystoscopy (3 months post-treatment)
Secondary 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. Radiotherapy treatment period (Days 14-28)
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