Trial Outcomes & Findings for Ultrasound-Guided Verteporfin Photodynamic Therapy for the Treatment of Unresectable Solid Pancreatic Tumors or Advanced Pancreatic Cancer, VERTPAC-02 Study (NCT NCT03033225)
NCT ID: NCT03033225
Last Updated: 2025-07-30
Results Overview
Assessed by the number of participants who did or did not respond, evaluated by tumor necrosis as a function of delivered energy, based on pre-photodynamic therapy (PDT) contrast computed tomography (CT) scans. Tumor volume response was graded per Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CT scans were obtained on day 2 following PDT. Most patients (87.5%) had a repeat CT of the abdomen and pelvis for reasons unrelated to the study; these CTs were also reviewed for tumor response.
COMPLETED
PHASE2
13 participants
Baseline (up to 28 days before PDF); 2 days post PDT; Up to 12 months post PDT
2025-07-30
Participant Flow
Between March 15, 2017 and July 20, 2019, 623 potential patients were examined for eligibility. Of these, 54 were confirmed eligible and approached for consideration. Eight participants proceeded to inclusion/study completion. Reasons for nonparticipation included nonresponse, unsuitable timing of study (for personal reasons or decision to initiate a chemotherapeutic agent), unsuitable location of study/unwillingness to travel to study site, and entry into a different research study.
Participant milestones
| Measure |
Treatment (Verteporfin, EUS-guided PDT)
Patients receive verteporfin IV and undergo fluorescence imaging and after 60 minutes undergo Endoscopic Ultrasound (EUS)-guided Photodynamic therapy (PDT).
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Treatment (Verteporfin, EUS-guided PDT)
Patients receive verteporfin IV and undergo fluorescence imaging and after 60 minutes undergo Endoscopic Ultrasound (EUS)-guided Photodynamic therapy (PDT).
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
Baseline Characteristics
Ultrasound-Guided Verteporfin Photodynamic Therapy for the Treatment of Unresectable Solid Pancreatic Tumors or Advanced Pancreatic Cancer, VERTPAC-02 Study
Baseline characteristics by cohort
| Measure |
Treatment (Verteporfin, EUS-guided PDT)
n=8 Participants
Patients receive verteporfin IV and undergo fluorescence imaging and after 60 minutes undergo EUS-guided PDT.
|
|---|---|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (up to 28 days before PDF); 2 days post PDT; Up to 12 months post PDTAssessed by the number of participants who did or did not respond, evaluated by tumor necrosis as a function of delivered energy, based on pre-photodynamic therapy (PDT) contrast computed tomography (CT) scans. Tumor volume response was graded per Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CT scans were obtained on day 2 following PDT. Most patients (87.5%) had a repeat CT of the abdomen and pelvis for reasons unrelated to the study; these CTs were also reviewed for tumor response.
Outcome measures
| Measure |
Treatment (Verteporfin, EUS-guided PDT)
n=8 Participants
Patients receive verteporfin IV and undergo fluorescence imaging and after 60 minutes undergo EUS-guided PDT.
|
|---|---|
|
Tumor Response
PDT Response
|
5 Participants
|
|
Tumor Response
PDT Non-response
|
3 Participants
|
Adverse Events
Treatment (Verteporfin, EUS-guided PDT)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place