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

NCT02916745 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2020-03-04

Study results available
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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.

Conditions

  • Non-small Cell Lung Cancer (NSCLC)
  • Lung Metastasis

Interventions

DRUG

Porfimer sodium

After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.

DEVICE

Fiber optic

A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.

Sponsors & Collaborators

  • Concordia Laboratories Inc.

    lead INDUSTRY

Principal Investigators

  • Michelle Depot, Ph.D. · at the request of Concordia Laboratories Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-26
Primary Completion
2019-04-12
Completion
2019-04-12
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02916745 on ClinicalTrials.gov