Trial Outcomes & Findings for Radiopaque Hydrogel in Patients Undergoing Radiotherapy for Pancreatic Cancer (NCT NCT03307564)

Last Updated: 2024-04-25

Results Overview

Measured as number of patients where marking the interface between the pancreas and duodenum with TraceIT Tissue Marker in patients undergoing image-guided radiotherapy for BR/LAPC pancreatic adenocarcinoma was achieved.

Recruitment status

COMPLETED

Study phase

Target enrollment

6 participants

Primary outcome timeframe

day 1

Results posted on

2024-04-25

Participant Flow

Participant milestones

Participant milestones
Measure	TraceIT Tissue Marker Injection The TraceIT injection will be performed during the endoscopic fiducial placement which is the standard of care. CTs to serially confirm TraceIT positioning will be performed on the same day during patient visits for their middle (2nd or 3rd fraction) and last (5th fraction) radiation therapy treatments TraceIT tissue marker injection: The TraceIT injection will be performed during the endoscopic fiducial placement which is the standard of care. CTs to serially confirm TraceIT positioning will be performed on the same day during patient visits for their middle (2nd or 3rd fraction) and last (5th fraction) radiation therapy treatments.
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Radiopaque Hydrogel in Patients Undergoing Radiotherapy for Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TraceIT Tissue Marker Injection n=6 Participants The TraceIT injection will be performed during the endoscopic fiducial placement which is the standard of care. CTs to serially confirm TraceIT positioning will be performed on the same day during patient visits for their middle (2nd or 3rd fraction) and last (5th fraction) radiation therapy treatments TraceIT tissue marker injection: The TraceIT injection will be performed during the endoscopic fiducial placement which is the standard of care. CTs to serially confirm TraceIT positioning will be performed on the same day during patient visits for their middle (2nd or 3rd fraction) and last (5th fraction) radiation therapy treatments.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race/Ethnicity, Customized white/caucasian	3 Participants n=5 Participants
Race/Ethnicity, Customized asian	1 Participants n=5 Participants
Race/Ethnicity, Customized other	2 Participants n=5 Participants
Region of Enrollment United States	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: day 1

Outcome measures

Outcome measures
Measure	TraceIT Tissue Marker Injection n=6 Participants The TraceIT injection will be performed during the endoscopic fiducial placement which is the standard of care. CTs to serially confirm TraceIT positioning will be performed on the same day during patient visits for their middle (2nd or 3rd fraction) and last (5th fraction) radiation therapy treatments TraceIT tissue marker injection: The TraceIT injection will be performed during the endoscopic fiducial placement which is the standard of care. CTs to serially confirm TraceIT positioning will be performed on the same day during patient visits for their middle (2nd or 3rd fraction) and last (5th fraction) radiation therapy treatments.
Number of Patients Where TraceIT Tissue Marker Placement Achieved	6 Participants

Adverse Events

TraceIT Tissue Marker Injection

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	TraceIT Tissue Marker Injection n=6 participants at risk The TraceIT injection will be performed during the endoscopic fiducial placement which is the standard of care. CTs to serially confirm TraceIT positioning will be performed on the same day during patient visits for their middle (2nd or 3rd fraction) and last (5th fraction) radiation therapy treatments TraceIT tissue marker injection: The TraceIT injection will be performed during the endoscopic fiducial placement which is the standard of care. CTs to serially confirm TraceIT positioning will be performed on the same day during patient visits for their middle (2nd or 3rd fraction) and last (5th fraction) radiation therapy treatments.
Gastrointestinal disorders nausea	16.7% 1/6 • Number of events 6 • immediate post-procedure period (approximately 3 hours after injection of hydrogel while patients in recovery/observation)

Other adverse events

Adverse event data not reported

Additional Information

Amol Narang. MD

SKCCC @ Johns Hopkins

Phone: 410-955-7390

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place