Trial Outcomes & Findings for TracelT Hydrogel in Localizing Bladder Tumors in Patients Undergoing Radiation Therapy for Bladder Cancer (NCT NCT03125226)

Results Overview

Daily changes will be compared across the patient group as well as within each subjects' treatment course.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

Baseline up to 8 weeks

Results posted on

2021-02-25

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Supportive Care (TracelT Hydrogel) n=12 Participants 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
Age, Categorical <=18 years	0 Participants n=12 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=12 Participants
Age, Categorical >=65 years	10 Participants n=12 Participants
Age, Continuous	73 years n=12 Participants
Sex: Female, Male Female	1 Participants n=12 Participants
Sex: Female, Male Male	11 Participants n=12 Participants
Region of Enrollment United States	12 Participants n=12 Participants

PRIMARY outcome

Timeframe: Baseline up to 8 weeks

Daily changes will be compared across the patient group as well as within each subjects' treatment course.

Outcome measures

Outcome measures
Measure	Supportive Care (TracelT Hydrogel) n=12 Participants 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
Changes in Interfraction Motion of the Marker Measured by Cone Beam Computed Tomography (CT) and x/y/z Coordinates	0.62 cm Standard Error 0.54

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Supportive Care (TracelT Hydrogel) n=12 Participants 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
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 cm Standard Error 0.48

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Supportive Care (TracelT Hydrogel) n=12 Participants 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
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 percentage of total dose Standard Error 2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Supportive Care (TracelT Hydrogel) n=12 Participants 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
Daily Dose to the Planning Tumor Volume (PTV) Based on Hydrogel Location	99 percentage of total dose Standard Error 2

SECONDARY outcome

Timeframe: Up to 1 year

Graded by the Common Terminology Criteria in Adverse Events version 4.0

Outcome measures

Outcome measures
Measure	Supportive Care (TracelT Hydrogel) n=12 Participants 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
Number of Participants With Adverse Events Caused by Hydrogel	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Supportive Care (TracelT Hydrogel) n=12 Participants 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
Smallest Setup Margin Required for Consistent Coverage of the Gross Tumor Volume (GTV)	10 mm Standard Deviation 3

Adverse Events

Supportive Care (TracelT Hydrogel)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Supportive Care (TracelT Hydrogel) n=12 participants at risk 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
Renal and urinary disorders Urinary frequency	16.7% 2/12 • Number of events 2 • 3 months

Additional Information

Dr. Jing Zeng

University of Washington School of Medicine

Phone: 2065985998

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place