Clinical trial · Interventional
Novel Light Delivery Methods for Lung Cancer Photodynamic Therapy - A Pilot Study
Single Center, Prospective, Open Label, Single-arm Clinical Study of Safety & Feasibility of Using Navigational Bronchoscopy to Perform Interstitial PD Therapy Using Lipiodol® as a Light Deliver and Photofrin® as Treatment in Subjects With Unresectable Solid Tumor in Peripheral Lung
NCT04753918CI-TRIAL-00050053unknownEarly Phase 1ClinicalTrials.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 and feasibility of using a newly developed bronchoscopic light delivery method of photodynamic therapy to treat subjects with solid tumors in peripheral lung, who are inoperable or refused surgery.
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 | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ethiodized oil | Drug | — | UNRESOLVED |
| Fiber optic | Device | — | UNRESOLVED |
| Novel light delivery methods of photodynamic therapy | Procedure | — | UNRESOLVED |
| Porfimer sodium | Drug | Porfimer | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Novel light delivery methods for photodynamic therapy
- description
- High refraction-index contrast medium: Lipiodol injected in the bronchial tree can enhance the treatment extension of the photodynamic therapy
- interventionNames
- Drug: Porfimer sodium
- Drug: Ethiodized oil
- Procedure: Novel light delivery methods of photodynamic therapy
- Device: Fiber optic
Primary outcomes (2)
- measure
- Feasibility to Perform Novel Photodynamic Therapy 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 Novel Photodynamic Therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female aged between 20 and 75 * Diagnosed with histologically confirmed solid tumor located in the peripheral lung * Not candidate or failed of standard chemotherapy, radiotherapy or surgery * Primary lung cancer without mediastinal or distant lymph nodes metastasis (N0-N1) * The tumor is ≤ 2 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 or non-solid malignancy * Solid tumor located in central lung * Primary lung cancer without distant metastasis (M0) * Received radiotherapy over the target tumor * Abnormal blood results * Received chemotherapy/immunotherapy in the last 4 weeks * Tumor invasion with major blood vessels * Allergy to porphyria or known hypersensitivity to Photofrin® or porphyrin-like compounds or to any of its excipients, allergy to Lipiodol or iodine-content contrast medium * 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 1 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 * Victim of AIDS * Other critical condition that the investigator considered not suited for participation
References
Publications (3)
- RESULTChang H, Liao KS, Hsieh YS. Bronchoscopic light delivery method for peripheral lung cancer photodynamic therapy. J Thorac Dis. 2020 Jul;12(7):3611-3621. doi: 10.21037/jtd-19-3887. PMID 32802440
- RESULTFriedberg JS, Skema C, Burdick J, Yodh AG, Carr SR, Culver JP. A novel technique for light delivery through branched or bent anatomic structures. J Thorac Cardiovasc Surg. 2003 Dec;126(6):1963-7. doi: 10.1016/s0022-5223(03)01320-5. PMID 14688713
- RESULTChen KC, Lee JM. Photodynamic therapeutic ablation for peripheral pulmonary malignancy via electromagnetic navigation bronchoscopy localization in a hybrid operating room (OR): a pioneering study. J Thorac Dis. 2018 Apr;10(Suppl 6):S725-S730. doi: 10.21037/jtd.2018.03.139. PMID 29732193