Non-small Cell Lung Cancer (NSCLC) Clinical Trial
Official title:
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
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.
Status | Not yet recruiting |
Enrollment | 3 |
Est. completion date | February 2022 |
Est. primary completion date | September 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Taoyuan General Hospital |
Chang 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. — View Citation
Chen 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: 10.2103 — View Citation
Friedberg 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility to Perform Novel Photodynamic Therapy Into Tumor | Number of times photodynamic therapy was delivered into the tumor using navigational bronchoscopy for each subject. | Day 3 post-treatment | |
Primary | Adverse Events Incidence Indicating Safety of Novel Photodynamic Therapy | The incidence of adverse events following Novel PDT will be presented as the primary safety indicator for this treatment. | Up to 6 months | |
Secondary | Tumor Response at 3 Months Post Photodynamic Therapy (PDT) | From the start of treatment until 3 months post-treatment measured as per the Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria | Up to 3 months | |
Secondary | Tumor Response at Study Exit (6 Months) Post Photodynamic Therapy (PDT) | Up to 6 months | From the start of treatment until 6 months post-treatment measured as per the Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria |
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