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Advanced Pancreatic CarcinomaPhase 2NCT03033225

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

A Phase 2 study testing Endoscopic Ultrasound, Fluorescence Imaging and Photodynamic Therapy in people with Advanced Pancreatic Carcinoma and Locally Advanced Pancreatic Carcinoma, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Endoscopic Ultrasound, Fluorescence Imaging and Photodynamic Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteUnited States
Study dates
31 May 2017to 20 Sep 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Phase II Study of EUS-Guided Verteporfin PDT in Solid Pancreatic Tumors (VERTPAC-02)

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. To evaluate the predictability of tumor necrosis as a function of delivered energy, based on pre-PDT contrast computed tomography (CT) scans.

TERTIARY OBJECTIVE:

  1. Evaluate the safety of chemotherapy given two days after PDT.

QUARTERNARY OBJECTIVE:

  1. 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.

Being tested
Endoscopic Ultrasound, Fluorescence Imaging, Photodynamic Therapy, Quality-of-Life Assessment, Questionnaire Administration
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endoscopic UltrasoundProcedure or surgery

    Also called endosonography, EUS

    Undergo EUS-guided PDT

  • Fluorescence ImagingProcedure or surgery

    Undergo fluorescence imaging

  • Photodynamic TherapyDrug

    Also called PDT, Photoradiation Therapy

    Undergo EUS-guided PDT

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

  • VerteporfinDrug

    Also called Benzoporphyrin Derivative Monoacid Ring A, BPD-MA, Visudyne

    Given IV

Study groups in NCT03033225
Study groupRoleWhat they receive
Treatment (verteporfin, EUS-guided PDT)ExperimentalPatients receive verteporfin IV and undergo fluorescence imaging and after 60 minutes undergo EUS-guided PDT.
Receives: Procedure: Endoscopic Ultrasound; Procedure: Fluorescence Imaging; Drug: Photodynamic Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Verteporfin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline (up to 28 days before PDF); 2 days post PDT; Up to 12 months post PDT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2017 (estimated)
  2. Study start31 May 2017
  3. Primary completion20 Sep 2023
  4. Study completion20 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03033225
Sponsor's protocol ID
16-001243
Other IDs
NCI-2019-07003, 16-001243, P01CA084203
Status last verified
Dec 2023
First submitted
24 Jan 2017
Last updated
30 Jul 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 33647286

  • 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):175006. doi: 10.1088/1361-6560/ac1458.

    PubMed 34261044

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Endoscopic Ultrasound, Fluorescence Imaging and Photodynamic Therapy in people with Advanced Pancreatic Carcinoma and Locally Advanced Pancreatic Carcinoma, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tumor Response (time frame: Baseline (up to 28 days before PDF); 2 days post PDT; Up to 12 months post PDT). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03033225, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.

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