Safety of PDT-Photofrin® Prior to Lung Surgery

Study summary

This research study is being conducted to assess the safety of PDT in subjects with peripherally located malignant tumors in lung parenchyma prior to surgical resection. It will involve up to 10 sites in USA. Participation will last 4 months.

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Key things to know

Main goalOther

This describes the study’s primary purpose.

What is being studiedPorfimer Sodium and Fiber optic

The study team can explain what participation involves.

Who it may be forMetastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jan 13, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?8 U.S. locations

Locations may change over time.

Who runs it?Concordia Laboratories Inc.

Study sponsor

Study overview

What this study is about

Purpose: Other
Study type: Interventional
Phase: Phase 1
Sponsor: Concordia Laboratories Inc.
Interventions being studied: Drug: Porfimer Sodium; Device: Fiber optic

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Disease setting

Metastatic or stage IV→

Treatment approach

Surgery→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Male or female aged 18-79
Diagnosed with primary or metastatic tumor \< 5 cm located in peripheral lung that can be completely resectable
Candidate for surgical resection
Candidate for bronchoscopy
Tumor is accessible for unrestricted illumination of PDT
Subject is deemed likely to survive for at least 3 months
Non-menopausal/non-sterile female subject of childbearing potential has negative B-HCG (Human chorionic gonadotropin) at time of study entry
Non-menopausal/non-sterile female subject of childbearing potential uses medically acceptable form of birth control
Subject is able and willing to provide written informed consent to participate in the study, which must comply with ICH (International Council for Harmonisation) guidelines \& local requirements

Reasons someone may not be able to joinExclusion criteria

Diagnosis of small cell lung cancer or carcinoid tumors
Primary or metastatic lung tumor located in central lung or near vertebral body
Tumor invades a major blood vessel
Presence of concurrent non-solid malignancy
Tumor previously treated with radiation therapy
Chemotherapy in the last four weeks
Tumor treated with PDT within the last 3 months
Abnormal blood results
Subject with porphyria or hypersensitivity to Photofrin
Coexisting ophthalmic disease likely to required slit-lamp exam within next 90 days
Acute or chronic medical or psychological illness as judged clinical significant to PI to preclude bronchoscopy procedures
female who is breast-feeding or intends to breast-feed during study
subject who participated in another study within last 30 days or intends to participate in another study during this study

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Cedars-Sinai Medical CenterLos Angeles, California
University of ColoradoDenver, Colorado
Moffitt Cancer CenterTampa, Florida
Cancer Treatment Centers of America/SoutheasternAtlanta, Georgia
AMITA Health Alexian Brothers Medical CenterElk Grove Village, Illinois
Dubois Medical CenterDuBois, Pennsylvania
UT MD Anderson Cancer CenterHouston, Texas
Providence Health & ServicesSpokane, Washington

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 13, 2020. Always confirm current availability with the study team.

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