Actively Recruiting
Padeliporfin VTP Using Robotic Assisted Bronchoscopy in Peripheral Lung Cancer
Led by Impact Biotech Ltd · Updated on 2025-02-11
36
Participants Needed
1
Research Sites
187 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Padeliporfin VTP Using Robotic Assisted Bronchoscopy in Peripheral Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 or older
- Patients with primary lung lesions at high risk for lung cancer
- Biopsy confirmed malignancy before treatment
- Approved by a multidisciplinary team for VTP and surgery
- Tumor size 2 cm or less (Part A) and less than 3 cm (Part B)
- Negative mediastinal lymph node involvement confirmed by intraoperative evaluation
- Tumor located at least 2 cm away from central bronchial tree
- Lung lesion at least 1 cm away from pleura or fissures
- Eligible for bronchoscopy under general anesthesia
- Tumor accessible via robotic bronchoscopy
- ECOG performance score 0 to 2
- Estimated life expectancy of 3 months or more
- Adequate organ function
- Negative pregnancy test
You will not qualify if you...
- Tumor located within 2 cm of central bronchial tree or major mediastinal structures
- Lung lesion less than 1 cm from pleura or fissure
- Lung cancer lesion larger than 2 cm, or larger than 2-3 cm for expansion cohort
- Evidence of cancer spread to lymph nodes
- Tumor invading major blood vessels
- Prior VTP or photodynamic therapy exposure
- Pregnant or breastfeeding women
- Receiving other investigational treatments
- Significant co-morbidities including severe hypoxia, advanced heart failure, recent heart attack, serious arrhythmia, worsening lung disease, unstable vascular disease, inability to stop blood thinners, active infections
- Acute or chronic condition precluding safe bronchoscopy
- Medical or psychiatric conditions affecting safety or compliance
- Severe pulmonary hypertension
- Active cancer requiring further treatment
- Major surgery within the last 4 weeks
- Porphyria or allergy to padeliporfin or related compounds
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21224
Actively Recruiting
Research Team
E
Eyal Morag, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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