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Trial record 1 of 1 for:    NCT03125226
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TracelT Hydrogel in Localizing Bladder Tumors in Patients Undergoing Radiation Therapy for Bladder Cancer

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ClinicalTrials.gov Identifier: NCT03125226
Recruitment Status : Recruiting
First Posted : April 24, 2017
Last Update Posted : November 6, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bladder Carcinoma Device: Polyethylene Glycol Hydrogel Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TraceIT TM Hydrogel Tissue Marker for Patients Receiving Definitive Chemoradiation for Bladder Cancer
Actual Study Start Date : October 5, 2017
Estimated Primary Completion Date : May 16, 2019
Estimated Study Completion Date : May 16, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: 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.
Device: Polyethylene Glycol Hydrogel
Given TracelT hydrogel via injection
Other Name: PEG Hydrogel




Primary Outcome Measures :
  1. Changes in interfraction motion of the marker measured by cone beam computed tomography (CT) and x/y/z coordinates [ Time Frame: Baseline up to 8 weeks ]
    Daily changes will be compared across the patient group as well as within each subjects' treatment course. Independent non-parametric testing of systematic (mean) errors in hydrogel marker position and tumor bed size variation between patients, as well as testing of random (root-mean-square error, pooled deviation) residual errors in hydrogel marker position between patients, will be conducted using Kruskal-Wallis analysis of variance (ANOVA) (k patient samples). Parametric ANOVA testing will be performed in order to detect differences in hydrogel positioning error in the range of 5-10 mm at 8

  2. Changes in tumor bed size and shape as delineated by the hydrogel and measured by cone beam CT and x/y/z coordinates [ Time Frame: Baseline up to 8 weeks ]
    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. Independent non-parametric testing of systematic (mean) errors in hydrogel marker position and tumor bed size variation between patients, as well as testing of random (root-mean-square error, pooled deviation) residual errors in hydrogel marker position between patients, will be conducted using Kruskal-Wallis ANOVA (k patient samples).


Secondary Outcome Measures :
  1. 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 [ Time Frame: Up to 8 weeks ]
    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.

  2. Daily dose to the planning tumor volume (PTV) based on hydrogel location [ Time Frame: Up to 8 weeks ]
    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.

  3. Incidence of adverse events [ Time Frame: Up to 1 year ]
    Graded by the Common Terminology Criteria in Adverse Events version 4.0

  4. Smallest setup margin required for consistent coverage of the gross tumor volume (GTV) [ Time Frame: Up to 8 weeks ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed malignancy of the bladder
  • No prior cystectomy
  • Treatment plan for bladder must include at least 4 weeks of daily radiation treatment (most patients will receive chemotherapy concurrent with radiation, but this is not required for trial enrollment)
  • Patient must undergo TraceIT hydrogel placement within 8 weeks prior to starting radiation therapy for bladder cancer
  • Participants must have a complete history and physical examination within 60 days of study entry
  • Participants must be able to provide informed consent for treatment and trial participation
  • No restrictions on prior treatment to be eligible

Exclusion Criteria:

  • Prior cystectomy
  • Unable to have TraceIT hydrogel placement < 8 weeks prior to beginning radiation treatment
  • Treatment for metastatic bladder cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03125226


Locations
United States, Washington
Fred Hutch/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Jing Zeng    206-598-4100    jzeng13@uw.edu   
Principal Investigator: Jing Zeng         
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jing Zeng Fred Hutch/University of Washington Cancer Consortium

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT03125226     History of Changes
Other Study ID Numbers: 9798
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 )
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases