Trial of Photodynamic Therapy Versus Argon Plasma Coagulation for Lung Cancer With Endobronchial Obstruction
NCT03564054 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3
Last updated 2019-12-18
Summary
The purpose of the study is to assess the efficacy of photodynamic therapy (PDT) in relieving airway obstruction in subjects with lung cancer compared to treatment with argon plasma coagulation (APC).
Conditions
- Non Small Cell Lung Cancer
Interventions
- PROCEDURE
-
Photodynamic Therapy
Participants on this arm will be treated with photodynamic therapy. PDT is a two-stage process. The first stage of PDT is the intravenous injection of porfimer sodium (Photofrin) administered as a single slow intravenous injection over 3 to 5 minutes. The second stage involves the application of laser light to the tumor by bronchoscopy.
- PROCEDURE
-
Argon Plasma Coagulation
Participants on this arm will be treated with argon plasma coagulation. A flexible probe housing a wire delivers high-frequency, high-voltage electric current to a monopolar tungsten electrode present at the tip of the probe. Argon gas flows through the probe, and is charged or ionized to produce "plasma" as it flows around the tungsten electrode. Electric current flows through the plasma to the nearest tissue, and heat is produced as it passes through the tissue. Increased resistance created by coagulated tissue impairs the flow of electric current, and keeps the ablation depth to 1 to 2 mm.
Sponsors & Collaborators
-
Concordia Laboratories Inc.
collaborator INDUSTRY -
University of Florida
lead OTHER
Principal Investigators
-
Michael Jantz, MD · University of Florida
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-10-11
- Primary Completion
- 2019-09-30
- Completion
- 2019-09-30
Countries
- United States
Study Locations
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