Status:
UNKNOWN
Novel Light Delivery Methods for Lung Cancer Photodynamic Therapy - A Pilot Study
Lead Sponsor:
Taoyuan General Hospital
Conditions:
Non-small Cell Lung Cancer (NSCLC)
Lung Metastasis
Eligibility:
All Genders
20-75 years
Phase:
EARLY_PHASE1
Brief Summary
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 i...
Detailed Description
Lung cancer accounts for almost one-third of cancer deaths. Cancer screening strategies have the potential to achieve a 20% reduction in death rates. Newly developed bronchoscopic technologies (such a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2022
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04753918
Start Date
March 1 2021
End Date
February 1 2022
Last Update
February 15 2021
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