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Photodynamic Therapy
Ultrasound-Guided Photodynamic Therapy for Pancreatic Cancer
Phase 2
Waitlist Available
Led By Vinay Chandrasekhara, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post photodynamic therapy (pdt)
Awards & highlights
Study Summary
This trial looks at whether a less invasive laser therapy, guided by ultrasound imaging, is as effective as current methods for treating patients with pancreatic cancer that has spread to other parts of the body.
Who is the study for?
This trial is for adults over 18 with advanced or inoperable pancreatic cancer, who have managed biliary drainage and no severe infections. Women must test negative for pregnancy and use contraception. Participants should be physically able to give consent, have a life expectancy of at least 12 weeks, and not be severely ill or on anticoagulants.Check my eligibility
What is being tested?
The VERTPAC-02 study tests ultrasound-guided verteporfin photodynamic therapy (PDT) on patients with solid pancreatic tumors that can't be surgically removed or have spread. It combines laser technology guided by ultrasound with the drug verteporfin as a potential less invasive treatment option.See study design
What are the potential side effects?
Possible side effects include reactions related to the laser procedure like tissue damage around the pancreas, pain during treatment, photosensitivity due to verteporfin, nausea, and general discomfort from endoscopic procedures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months post photodynamic therapy (pdt)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post photodynamic therapy (pdt)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Tumor response
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (verteporfin, EUS-guided PDT)Experimental Treatment6 Interventions
Patients receive verteporfin IV and undergo fluorescence imaging and after 60 minutes undergo EUS-guided PDT.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Endoscopic Ultrasound
2010
Completed Phase 2
~350
Fluorescence Imaging
2014
Completed Phase 2
~100
Verteporfin
2007
Completed Phase 4
~150
Photodynamic Therapy
2014
Completed Phase 4
~460
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,351 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,239 Previous Clinical Trials
3,771,586 Total Patients Enrolled
Vinay Chandrasekhara, M.D.Principal InvestigatorMayo Clinic in Rochester
1 Previous Clinical Trials
25 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a condition called porphyria.You have a high level of difficulty performing everyday activities.You have a mental health condition that makes it hard to understand and agree to the study.You are older than 18 years.You have a history of serious bleeding or blood clotting issues and are currently taking medication to prevent blood clots.You have had another type of cancer that could affect how we check the response to the treatment.Your bilirubin levels are within a certain range, and you do not have an active, uncontrolled infection. If you are taking antibiotics, you can still participate.If you have cancer that has spread, it cannot have spread to certain places in the body. If the cancer has spread to the lungs, it cannot have more than three lesions, and none of the lesions can be larger than 5 cm.The cancer has spread to more than half of the duodenum or a major artery in the treatment area.You have been diagnosed with advanced or locally advanced pancreatic cancer or another solid pancreatic tumor that cannot be removed with surgery.You are allergic to contrast dye and cannot be treated with steroids and antihistamines.You have a tumor that can be measured using specific guidelines.You are expected to live for at least 12 more weeks.You are able to perform daily activities with little to no difficulty.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (verteporfin, EUS-guided PDT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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