← Back to all trials
Active Not Recruiting
NCT05918783
Padeliporfin VTP Using Robotic Assisted Bronchoscopy in Peripheral Lung Cancer
Conditions: Peripheral Lung Tumor
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 36
Sponsor: Impact Biotech Ltd
Location: Johns Hopkins University School of Medicine Baltimore Maryland
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.
Eligibility Criteria
Inclusion Criteria:
1. Age ≥18
2. Patients with primary lung lesions who are at high risk for primary lung cancer.
2.1.Biopsy with intraoperative confirmation of malignancy using on-site cytology will be used as final inclusion prior to study treatment.
3. All patients will be approved by a multi-disciplinary team (thoracic surgery, interventional pulmonology, medical oncology and radiation oncology) as appropriate for bronchoscopic VTP prior to surgical resection.
4. Tumor size targeted for VTP treatment ≤ 2 cm (Part A) and \
Source: ClinicalTrials.gov (NCT05918783). StuddyBuddy aggregates publicly available trial information.
