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

Completed · Phase 1

Conditions studied: Non-small Cell Lung Cancer (NSCLC), Lung Metastasis

In brief

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.

Key facts

Study ID

NCT02916745

Run by

Concordia Laboratories Inc.

People needed

5

Starts

2017-01-26

Expected to finish

2019-04-12

Last updated by the study team

2020-03-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Florida — Gainesville, Florida, United States
• Southeastern Regional Medical Center — Atlanta, Georgia, United States
• Alexian Brothers Hospital Network — Elk Grove Village, Illinois, United States
• Southwestern Regional Medical Center — Tulsa, Oklahoma, United States
• Providence Medical Research Center — Spokane, Washington, United States
• University of Wisconsin-Madison — Madison, Wisconsin, United States
• Toronto General Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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