Clinical trial · Interventional
Feasibility Study of Using Navigational Bronchoscopy to Perform PDT-Photofrin® in Unresectable Peripheral Lung Cancer
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
- 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 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.
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 Metastasis | Lung Neoplasm | PROBABILISTIC | 0.70 |
| Non-small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
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 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.
- interventionNames
- Drug: Porfimer sodium
- Device: Fiber optic
Primary outcomes (2)
- measure
- Feasibility to Perform Interstitial-Photodynamic Therapy (i-PDT) Into Tumor
- timeFrame
- Day 3 post-treatment
- description
- Number of times photodynamic therapy was delivered into the tumor using navigational bronchoscopy for each subject.
- measure
- Adverse Events Incidence Indicating Safety of Navigational Bronchoscopy-interstitial-Photodynamic Therapy (i-PDT)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female aged 18 or older * Diagnosed with histologically confirmed solid tumor located in the peripheral lung * Not candidate for curative surgery, is unfit for surgery, or does not wish to undergo curative surgery * May be candidate for, have failed, or does not wish to undergo radiation therapy * The tumor is ≤ 3 cm in size and clearly observable in computerized tomography (CT scan) * Able to sign an informed consent Exclusion Criteria: * Diagnostic of small cell lung cancer * Solid tumor located in central lung * Presence of concurrent non-solid malignancy * Abnormal blood results * Received chemotherapy/immunotherapy in the last 4 weeks * Tumor invades a major blood vessel * Porphyria or known hypersensitivity to Photofrin® or porphyrin-like compounds or to any of its excipients * Planned surgical procedure within the next 90 days * Coexisting ophthalmic disease likely to require slit-lamp examination within the next 90 days * Acute or chronic medical or psychological illnesses that prevent endoscopy procedures * Pregnant or intend to become pregnant, breastfeeding or intend to breastfeed during the study * Received PDT during the past 3 months * Severe impairment of your kidney or liver function * Participates or intends to participate in another drug study (other than observational studies) during the study
References
Publications (0)
Data not yet available