Ultrasound-Guided Verteporfin Photodynamic Therapy for the Treatment of Unresectable Solid Pancreatic Tumors or Advanced Pancreatic Cancer, VERTPAC-02 Study
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|ClinicalTrials.gov Identifier: NCT03033225|
Recruitment Status : Recruiting
First Posted : January 26, 2017
Last Update Posted : September 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Advanced Pancreatic Carcinoma Locally Advanced Pancreatic Carcinoma Metastatic Pancreatic Carcinoma Pancreatic Neoplasm Stage II Pancreatic Cancer AJCC v8 Stage IIA Pancreatic Cancer AJCC v8 Stage IIB Pancreatic Cancer AJCC v8 Stage III Pancreatic Cancer AJCC v8 Stage IV Pancreatic Cancer AJCC v8 Unresectable Pancreatic Carcinoma||Procedure: Endoscopic Ultrasound Drug: Photodynamic Therapy Other: Quality-of-Life Assessment Other: Questionnaire Administration Drug: Verteporfin||Phase 2|
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.
I. To evaluate the predictability of tumor necrosis as a function of delivered energy, based on pre-PDT contrast computed tomography (CT) scans.
I. Evaluate the safety of chemotherapy given two days after PDT.
I. Demonstrate that cancer biomarkers in pre- versus (vs.) post-PDT are surrogate markers of response.
Patients receive verteporfin intravenously (IV) 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of EUS-Guided Verteporfin PDT in Solid Pancreatic Tumors (VERTPAC-02)|
|Actual Study Start Date :||December 6, 2016|
|Estimated Primary Completion Date :||December 30, 2021|
|Estimated Study Completion Date :||December 30, 2021|
Experimental: Treatment (verteporfin, EUS-guided PDT)
Patients receive verteporfin IV and after 60 minutes undergo EUS-guided PDT.
Procedure: Endoscopic Ultrasound
Undergo EUS-guided PDT
Drug: Photodynamic Therapy
Undergo EUS-guided PDT
Other: Quality-of-Life Assessment
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
- Tumor response [ Time Frame: 12 months post photodynamic therapy (PDT) ]To evaluate the predictability of tumor necrosis as a function of delivered energy, based on pre-PDT contrast computed tomography (CT) scans.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03033225
|United States, Minnesota|
|Mayo Clinic in Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Contact: Clincial Trials Referral Office 855-776-0015 firstname.lastname@example.org|
|Principal Investigator: Kenneth K. Wang|
|Principal Investigator:||Kenneth K Wang||Mayo Clinic in Rochester|