Clinical trial · Interventional
Safety of PDT-Photofrin® Prior to Lung Surgery
A Multicenter, Prospective, Open-label, Non-randomized Single-arm Clinical Study of the Safety and Tissue Response to Photodynamic Therapy Using Porfimer Sodium for Injection as Treatment for Solid Lung Tumor Prior to Surgical Resection
NCT03344861CI-TRIAL-00042727completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This research study is being conducted to assess the safety of PDT in subjects with peripherally located malignant tumors in lung parenchyma prior to surgical resection. It will involve up to 10 sites in USA. Participation will last 4 months.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer Metastatic | Lung Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fiber optic | Device | — | UNRESOLVED |
| Porfimer Sodium | Drug | Porfimer | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Photodynamic therapy-Photofrin
- description
- Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.
- interventionNames
- Drug: Porfimer Sodium
- Device: Fiber optic
Primary outcomes (5)
- measure
- Safety: Number of Participants With at Least One Adverse Event
- timeFrame
- 108 days (to 3 months post surgery)
- description
- Safety evaluation will include incidence of all adverse events, including serious and non-serious. The count of how many subjects experienced at least one adverse event.
- measure
- Safety: Physical Examination Summaries of Non-normal Findings for Each Subject
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female aged 18-79 * Diagnosed with primary or metastatic tumor \< 5 cm located in peripheral lung that can be completely resectable * Candidate for surgical resection * Candidate for bronchoscopy * Tumor is accessible for unrestricted illumination of PDT * Subject is deemed likely to survive for at least 3 months * Non-menopausal/non-sterile female subject of childbearing potential has negative B-HCG (Human chorionic gonadotropin) at time of study entry * Non-menopausal/non-sterile female subject of childbearing potential uses medically acceptable form of birth control * Subject is able and willing to provide written informed consent to participate in the study, which must comply with ICH (International Council for Harmonisation) guidelines \& local requirements Exclusion Criteria: * Diagnosis of small cell lung cancer or carcinoid tumors * Primary or metastatic lung tumor located in central lung or near vertebral body * Tumor invades a major blood vessel * Presence of concurrent non-solid malignancy * Tumor previously treated with radiation therapy * Chemotherapy in the last four weeks * Tumor treated with PDT within the last 3 months * Abnormal blood results * Subject with porphyria or hypersensitivity to Photofrin * Coexisting ophthalmic disease likely to required slit-lamp exam within next 90 days * Acute or chronic medical or psychological illness as judged clinical significant to PI to preclude bronchoscopy procedures * female who is breast-feeding or intends to breast-feed during study * subject who participated in another study within last 30 days or intends to participate in another study during this study
References
Publications (0)
Data not yet available
No reference posted for this study.