Ultrasound-Guided Verteporfin Photodynamic Therapy for the Treatment of Unresectable Solid Pancreatic Tumors or Advanced Pancreatic Cancer, VERTPAC-02 Study

NCT03033225 | Completed Phase 2 Results DMC

• 3 other identifiers: 16-001243NCI-2019-07003P01CA084203
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Pancreatic Carcinoma; Locally Advanced Pancreatic Carcinoma; Metastatic Pancreatic Carcinoma; Pancreatic Neoplasm; Stage II Pancreatic Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Unresectable Pancreatic Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Treatment (verteporfin, EUS-guided PDT)

EXPERIMENTAL

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

Interventions

Endoscopic Ultrasound PROCEDURE

Undergo EUS-guided PDT

Also known as: endosonography, EUS

Treatment (verteporfin, EUS-guided PDT)

Fluorescence Imaging PROCEDURE

Undergo fluorescence imaging

Treatment (verteporfin, EUS-guided PDT)

Photodynamic Therapy DRUG

Undergo EUS-guided PDT

Also known as: PDT, Photoradiation Therapy

Treatment (verteporfin, EUS-guided PDT)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (verteporfin, EUS-guided PDT)

Questionnaire Administration OTHER

Ancillary studies

Treatment (verteporfin, EUS-guided PDT)

Verteporfin DRUG

Given IV

Also known as: Benzoporphyrin Derivative Monoacid Ring A, BPD-MA, Visudyne

Treatment (verteporfin, EUS-guided PDT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological/cytological diagnosis (Dx) of advanced or locally advanced or small volume metastatic pancreatic cancer (PanCa) or other solid pancreatic tumor that is not amenable to curative surgical resection, or the patient is unfit, or declines surgery
• 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

You may not qualify if:

• For locally advanced patients, evidence of metastases other than lung or liver. For lung metastases, greater than three lesions and any lesions greater than 5 cm are excluded. For advanced patients, any metastasis is acceptable for enrollment
• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

• 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.

  PMID: 33647286 RESULT

• 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.

  PMID: 34261044 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration; Optical Imaging; Photochemotherapy; 1-phenyl-3,3-dimethyltriazene; Phototherapy; Verteporfin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques; Combined Modality Therapy; Therapeutics; Drug Therapy; Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Kenneth K. Wang, MD
• Organization: Mayo Clinic

wang.kenneth@mayo.edu

507-284-2511

Study Officials

• Vinay Chandrasekhara, M.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2017
• First Posted: January 26, 2017
• Study Start: May 31, 2017
• Primary Completion: September 20, 2023
• Study Completion: September 20, 2023
• Last Updated: July 30, 2025
• Results First Posted: July 30, 2025

Record last verified: 2023-12

Locations

US (1)