Feasibility Study of Using Navigational Bronchoscopy to Perform PDT-Photofrin® in Unresectable Peripheral Lung Cancer

• Status: Completed
• Trial end date: 2019-04-12
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Concordia Laboratories Inc.
• Treatments: Dihematoporphyrin Ether; Hematoporphyrin Derivative; Trioxsalen

Criteria

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