Feasibility Study of Using Navigational Bronchoscopy to Perform PDT-Photofrin® in Unresectable Peripheral Lung Cancer

Study summary

This research study is being conducted to assess the safety and feasibility of using a new developed bronchoscopic technology called electronavigational bronchoscopy to treat subjects with solid tumor in peripheral lung, who are inoperable or refused surgery. It will involve 10 sites in USA and Canada. Participation will last 6 months.

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Key things to know

Main goalTreatment

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 forNon-small cell lung cancer (NSCLC) · Early-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 4, 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?7 U.S. locations

Locations may change over time.

Who runs it?Concordia Laboratories Inc.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
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.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Early-stage or resectable→

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 or older
Diagnosed with histologically confirmed solid tumor located in the peripheral lung
Not candidate for curative surgery, is unfit for surgery, or does not wish to undergo curative surgery
May be candidate for, have failed, or does not wish to undergo radiation therapy
The tumor is ≤ 3 cm in size and clearly observable in computerized tomography (CT scan)
Able to sign an informed consent

Reasons someone may not be able to joinExclusion criteria

Diagnostic of small cell lung cancer
Solid tumor located in central lung
Presence of concurrent non-solid malignancy
Abnormal blood results
Received chemotherapy/immunotherapy in the last 4 weeks
Tumor invades a major blood vessel
Porphyria or known hypersensitivity to Photofrin® or porphyrin-like compounds or to any of its excipients
Planned surgical procedure within the next 90 days
Coexisting ophthalmic disease likely to require slit-lamp examination within the next 90 days
Acute or chronic medical or psychological illnesses that prevent endoscopy procedures
Pregnant or intend to become pregnant, breastfeeding or intend to breastfeed during the study
Received PDT during the past 3 months
Severe impairment of your kidney or liver function
Participates or intends to participate in another drug study (other than observational studies) during the 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

University of FloridaGainesville, Florida
Southeastern Regional Medical CenterAtlanta, Georgia
Alexian Brothers Hospital NetworkElk Grove Village, Illinois
Southwestern Regional Medical CenterTulsa, Oklahoma
Providence Medical Research CenterSpokane, Washington
University of Wisconsin-MadisonMadison, Wisconsin
Toronto General HospitalToronto, Ontario

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 4, 2020. Always confirm current availability with the study team.

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