Padeliporfin VTP Using Robotic Assisted Bronchoscopy in Peripheral Lung Cancer
NCT05918783 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2025-02-11
Summary
Phase 1/1b, safety, feasibility, and light dose titration study followed by further study of therapeutic ablation effects.
Patients with high risk of peripheral primary lung cancer, stage 1A1/1A2, for whom surgical treatment is planned, will be recruited. Surgery will be performed at 5-21 days following the VTP procedure.
Study intervention: robotic assisted bronchoscopic Padeliporfin VTP lung ablation: vascular targeted photodynamic therapy using Padeliporfin photosensitizer.
Conditions
- Peripheral Lung Tumor
Interventions
- COMBINATION_PRODUCT
-
Padeliporfin Vascular Targeted Photodynamic (VTP) therapy
Bronchoscopy will be performed with robotic assisted approach using standard practices using general anaesthesia and placement of the optic fiber intratumorally followed by IV administration of Padeliporfin for 10 min and laser light illumination.
Sponsors & Collaborators
-
Impact Biotech Ltd
lead INDUSTRY
Principal Investigators
-
Lonny Yarmus, MD · Johns Hopkins University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-28
- Primary Completion
- 2027-05-30
- Completion
- 2028-12-30
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- United States
Study Locations
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