N/A
N=12
TracelT Hydrogel in Localizing Bladder Tumors in Patients Undergoing Radiation Therapy for Bladder Cancer
Bladder Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT03125226 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Changes in Interfraction Motion of the Marker Measured by Cone Beam Computed Tomography (CT) and x/y/z Coordinates — 0.62 cm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Polyethylene Glycol Hydrogel (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Interfraction Motion of the Marker Measured by Cone Beam Computed Tomography (CT) and x/y/z Coordinates |
0.62 | — |
| PRIMARY Changes in Tumor Bed Size and Shape as Delineated by the Hydrogel and Measured by Cone Beam CT and x/y/z Coordinates |
0.21 | — |
| 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 |
95 | — |
| SECONDARY Daily Dose to the Planning Tumor Volume (PTV) Based on Hydrogel Location |
99 | — |
| SECONDARY Number of Participants With Adverse Events Caused by Hydrogel |
— | — |
| SECONDARY Smallest Setup Margin Required for Consistent Coverage of the Gross Tumor Volume (GTV) |
10 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03125226). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.