Novel Light Delivery Methods for Lung Cancer Photodynamic Therapy - A Pilot Study

• Status: Not yet recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

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 in peripheral lung, who are inoperable or refused surgery.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taoyuan General Hospital
• Treatments: Dihematoporphyrin Ether; Ethiodized Oil; Trioxsalen

Criteria

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