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2017-05-31
2023-09-20
2023-09-20
13
NCT03033225
Mayo Clinic
Mayo Clinic
INTERVENTIONAL
Ultrasound-Guided Verteporfin Photodynamic Therapy for the Treatment of Unresectable Solid Pancreatic Tumors or Advanced Pancreatic Cancer, VERTPAC-02 Study
This phase II trial studies how well ultrasound-guided verteporfin photodynamic therapy works for the treatment of patients with solid pancreatic tumors that cannot be removed by surgery (unresectable) or pancreatic cancer that has spread to other places in the body (advanced). Photodynamic therapy is a type of laser device that is guided by ultrasound imaging and used in combination with the drug verteporfin that may be less invasive and as effective as current treatment methods for patients with pancreatic cancer.
PRIMARY OBJECTIVE: I. To show that endoscopic ultrasound (EUS)-guided photodynamic therapy (PDT) to the pancreas is effective at direct ablation of advanced or locally advanced and small volume metastatic pancreatic tumors in a multicenter setting. SECONDARY OBJECTIVE: I. To evaluate the predictability of tumor necrosis as a function of delivered energy, based on pre-PDT contrast computed tomography (CT) scans. TERTIARY OBJECTIVE: I. Evaluate the safety of chemotherapy given two days after PDT. QUARTERNARY OBJECTIVE: I. Demonstrate that cancer biomarkers in pre- versus (vs.) post-PDT are surrogate markers of response. OUTLINE: Patients receive verteporfin intravenously (IV) and undergo fluorescence imaging and after 60 minutes undergo EUS-guided PDT. After completion of study treatment, patients are followed up at 14 days, and at 3, 6, and 12 months.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2017-01-24 | 2025-06-24 | 2025-07-10 |
2017-01-24 | 2025-07-10 | 2025-07-30 |
2017-01-26 | 2025-07-30 | 2023-12 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Treatment (verteporfin, EUS-guided PDT) Patients receive verteporfin IV and undergo fluorescence imaging and after 60 minutes undergo EUS-guided PDT. | PROCEDURE: Endoscopic Ultrasound
PROCEDURE: Fluorescence Imaging
DRUG: Photodynamic Therapy
OTHER: Quality-of-Life Assessment
OTHER: Questionnaire Administration
DRUG: Verteporfin
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Tumor Response | 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. | Baseline (up to 28 days before PDF); 2 days post PDT; Up to 12 months post PDT |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
