At a glance
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Multicenter, Prospective, OL, Single-arm Clinical Study of Safety & Feasibility of Using Navigational Bronchoscopy to Perform Interstitial PD Therapy Using Photofrin® as Treatment in Subjects With Unresectable Solid Tumor in Peripheral Lung
In Brief
A Phase 1 clinical trial evaluating Porfimer sodium and Fiber optic for Non-small Cell Lung Cancer (NSCLC) and Lung Metastasis. Completed, enrolled 5 participants across 7 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
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.
A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.