Ultrasound-Guided Verteporfin Photodynamic Therapy for the Treatment of Unresectable Solid Pancreatic Tumors or Advanced Pancreatic Cancer, VERTPAC-02 Study
NCT ID: NCT03033225
Last Updated: 2025-07-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
13 participants
INTERVENTIONAL
2017-05-31
2023-09-20
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (verteporfin, EUS-guided PDT)
Patients receive verteporfin IV and undergo fluorescence imaging and after 60 minutes undergo EUS-guided PDT.
Endoscopic Ultrasound
Undergo EUS-guided PDT
Fluorescence Imaging
Undergo fluorescence imaging
Photodynamic Therapy
Undergo EUS-guided PDT
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Verteporfin
Given IV
Interventions
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Endoscopic Ultrasound
Undergo EUS-guided PDT
Fluorescence Imaging
Undergo fluorescence imaging
Photodynamic Therapy
Undergo EUS-guided PDT
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Verteporfin
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age \> 18 years
* Measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST)
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
* Estimated life expectancy of at least 12 weeks
* Capable of giving written informed consent
* Adequate biliary drainage (serum bilirubin \< 2.5 upper limit of normal \[ULN\]), with no evidence of active uncontrolled infection (patients on antibiotics are eligible)
* Women of child-bearing potential with a negative pregnancy test (qualitative serum human chorionic gonadotropin \[HCG\]) prior to study entry AND must be using an adequate contraception method, which must be continued for 1 week after PDT
Exclusion Criteria
* Porphyria
* Pregnant or breast-feeding
* Locally advanced disease involving \> 50% circumference of the duodenum or a major artery within the treatment area
* ECOG performance status 3 or 4
* Previous treatment with curative intent for current disease within the past two weeks (i.e. prior resection, radical radiotherapy or chemotherapy)
* Any psychiatric disorder making reliable informed consent impossible
* A history of documented hemorrhagic diathesis or coagulopathy on therapeutic anticoagulation
* History of prior or concomitant other malignancy that will interfere with the response evaluation
* Any evidence of severe or uncontrolled systemic diseases or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial
* Contrast allergy not amenable to treatment with steroids and antihistamines
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Vinay Chandrasekhara, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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References
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Hanada Y, Pereira SP, Pogue B, Maytin EV, Hasan T, Linn B, Mangels-Dick T, Wang KK. EUS-guided verteporfin photodynamic therapy for pancreatic cancer. Gastrointest Endosc. 2021 Jul;94(1):179-186. doi: 10.1016/j.gie.2021.02.027. Epub 2021 Feb 26.
Vincent P, Maeder ME, Hunt B, Linn B, Mangels-Dick T, Hasan T, Wang KK, Pogue BW. CT radiomic features of photodynamic priming in clinical pancreatic adenocarcinoma treatment. Phys Med Biol. 2021 Aug 23;66(17):10.1088/1361-6560/ac1458. doi: 10.1088/1361-6560/ac1458.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2019-07003
Identifier Type: REGISTRY
Identifier Source: secondary_id
16-001243
Identifier Type: OTHER
Identifier Source: secondary_id
16-001243
Identifier Type: -
Identifier Source: org_study_id
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