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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-00525 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 9798 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| P30CA015704 | U.S. NIH Grant/Contract | View source | |
| RG3117001 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This pilot clinical trial studies how well TracelT hydrogel works in localizing bladder tumors in patients undergoing radiation therapy for bladder cancer. TracelT hydrogel marks the location of a bladder tumor and makes it more visible during imaging tests. Using TracelT hydrogel tissue marker may help doctors learn more about tumor location and altering radiation dosage for bladder cancer.
PRIMARY OBJECTIVES:
I. To utilize the TraceIT hydrogel tissue marker in localizing bladder tumors during transurethral resection of bladder tumors (TURBT).
II. To improve identification of gross tumor or tumor bed location in patients receiving chemoradiation treatment for bladder cancers.
SECONDARY OBJECTIVES:
I. To report adverse events surrounding the placement of the TraceIT tissue marker.
II. To calculate the actual dose received by the bladder tumor bed, as delineated by the hydrogel.
III. To compare the dosimetric impact to the tumor bed of daily patient alignment to the pelvic bones, versus alignment to the whole bladder, versus alignment to the hydrogel markers.
IV. To calculate the amount of normal tissue radiation dose decrease achievable without losing tumor coverage, with better tumor targeting with hydrogel placement.
OUTLINE:
Patients undergo transurethral resection of bladder tumors and receive TracelT hydrogel via injection. Patients undergo standard of care radiation therapy within 8 weeks of TracelT hydrogel placement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (TracelT hydrogel) | Experimental | Patients undergo transurethral resection of bladder tumors and receive TracelT hydrogel via injection. Patients undergo standard of care radiation therapy within 8 weeks of TracelT hydrogel placement. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyethylene Glycol Hydrogel | Device | Given TracelT hydrogel via injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Interfraction Motion of the Marker Measured by Cone Beam Computed Tomography (CT) and x/y/z Coordinates | Daily changes will be compared across the patient group as well as within each subjects' treatment course. | Baseline up to 8 weeks |
| Changes in Tumor Bed Size and Shape as Delineated by the Hydrogel and Measured by Cone Beam CT and x/y/z Coordinates | Daily changes will be compared across the patient group as well as within each subjects' treatment course. These changes will be tracked during the entire radiation course (typically 4-8 weeks), yielded a distribution of x/y/z positions for each patient. | Baseline up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Dose of Radiation to the PTV as Based on Alignment to the Hydrogel Location Versus Alignment to Whole Bladder Location Versus Alignment to Bony Antonym | Daily pre-radiation imaging will be used to run the radiation treatment plan, to calculate the daily dose to the PTV based on alignment to the hydrogel location, versus alignment to whole bladder location, versus alignment to bony anatomy. | Up to 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jing Zeng | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Supportive Care (TracelT Hydrogel) | Patients undergo transurethral resection of bladder tumors and receive TracelT hydrogel via injection. Patients undergo standard of care radiation therapy within 8 weeks of TracelT hydrogel placement. Polyethylene Glycol Hydrogel: Given TracelT hydrogel via injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Supportive Care (TracelT Hydrogel) | Patients undergo transurethral resection of bladder tumors and receive TracelT hydrogel via injection. Patients undergo standard of care radiation therapy within 8 weeks of TracelT hydrogel placement. Polyethylene Glycol Hydrogel: Given TracelT hydrogel via injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Interfraction Motion of the Marker Measured by Cone Beam Computed Tomography (CT) and x/y/z Coordinates | Daily changes will be compared across the patient group as well as within each subjects' treatment course. | Posted | Mean | Standard Error | cm | Baseline up to 8 weeks |
|
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Supportive Care (TracelT Hydrogel) | Patients undergo transurethral resection of bladder tumors and receive TracelT hydrogel via injection. Patients undergo standard of care radiation therapy within 8 weeks of TracelT hydrogel placement. Polyethylene Glycol Hydrogel: Given TracelT hydrogel via injection |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary frequency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jing Zeng | University of Washington School of Medicine | 2065985998 | jzeng13@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 19, 2020 | Dec 2, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Daily Dose to the Planning Tumor Volume (PTV) Based on Hydrogel Location | Daily pre-radiation imaging will be used to run the radiation treatment plan, to calculate the daily dose to the PTV based on hydrogel location. Total radiation dose to the PTV can then be calculated as the sum of the daily dose. | Up to 8 weeks |
| Number of Participants With Adverse Events Caused by Hydrogel | Graded by the Common Terminology Criteria in Adverse Events version 4.0 | Up to 1 year |
| Smallest Setup Margin Required for Consistent Coverage of the Gross Tumor Volume (GTV) | Daily pre-radiation imaging will be used to identify the smallest setup margin required for consistent coverage of the GTV, which is likely smaller than the current standard of care setup margin of at least 2 cm around the GTV. | Up to 8 weeks |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Participants |
|
|
|
| Primary | Changes in Tumor Bed Size and Shape as Delineated by the Hydrogel and Measured by Cone Beam CT and x/y/z Coordinates | Daily changes will be compared across the patient group as well as within each subjects' treatment course. These changes will be tracked during the entire radiation course (typically 4-8 weeks), yielded a distribution of x/y/z positions for each patient. | Posted | Mean | Standard Error | cm | Baseline up to 8 weeks |
|
|
|
| Secondary | Daily Dose of Radiation to the PTV as Based on Alignment to the Hydrogel Location Versus Alignment to Whole Bladder Location Versus Alignment to Bony Antonym | Daily pre-radiation imaging will be used to run the radiation treatment plan, to calculate the daily dose to the PTV based on alignment to the hydrogel location, versus alignment to whole bladder location, versus alignment to bony anatomy. | Posted | Mean | Standard Error | percentage of total dose | Up to 8 weeks |
|
|
|
| Secondary | Daily Dose to the Planning Tumor Volume (PTV) Based on Hydrogel Location | Daily pre-radiation imaging will be used to run the radiation treatment plan, to calculate the daily dose to the PTV based on hydrogel location. Total radiation dose to the PTV can then be calculated as the sum of the daily dose. | Posted | Mean | Standard Error | percentage of total dose | Up to 8 weeks |
|
|
|
| Secondary | Number of Participants With Adverse Events Caused by Hydrogel | Graded by the Common Terminology Criteria in Adverse Events version 4.0 | Posted | Count of Participants | Participants | Up to 1 year |
|
|
|
| Secondary | Smallest Setup Margin Required for Consistent Coverage of the Gross Tumor Volume (GTV) | Daily pre-radiation imaging will be used to identify the smallest setup margin required for consistent coverage of the GTV, which is likely smaller than the current standard of care setup margin of at least 2 cm around the GTV. | Posted | Mean | Standard Deviation | mm | Up to 8 weeks |
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| 0 |
| 12 |
| 0 |
| 12 |
| 2 |
| 12 |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |