Status:
COMPLETED
Safety of PDT-Photofrin® Prior to Lung Surgery
Lead Sponsor:
Concordia Laboratories Inc.
Conditions:
Lung Cancer
Lung Cancer Metastatic
Eligibility:
All Genders
18-79 years
Phase:
PHASE1
Brief Summary
This research study is being conducted to assess the safety of PDT in subjects with peripherally located malignant tumors in lung parenchyma prior to surgical resection. It will involve up to 10 sites...
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 18-79
- Diagnosed with primary or metastatic tumor \< 5 cm located in peripheral lung that can be completely resectable
- Candidate for surgical resection
- Candidate for bronchoscopy
- Tumor is accessible for unrestricted illumination of PDT
- Subject is deemed likely to survive for at least 3 months
- Non-menopausal/non-sterile female subject of childbearing potential has negative B-HCG (Human chorionic gonadotropin) at time of study entry
- Non-menopausal/non-sterile female subject of childbearing potential uses medically acceptable form of birth control
- Subject is able and willing to provide written informed consent to participate in the study, which must comply with ICH (International Council for Harmonisation) guidelines \& local requirements
Exclusion
- Diagnosis of small cell lung cancer or carcinoid tumors
- Primary or metastatic lung tumor located in central lung or near vertebral body
- Tumor invades a major blood vessel
- Presence of concurrent non-solid malignancy
- Tumor previously treated with radiation therapy
- Chemotherapy in the last four weeks
- Tumor treated with PDT within the last 3 months
- Abnormal blood results
- Subject with porphyria or hypersensitivity to Photofrin
- Coexisting ophthalmic disease likely to required slit-lamp exam within next 90 days
- Acute or chronic medical or psychological illness as judged clinical significant to PI to preclude bronchoscopy procedures
- female who is breast-feeding or intends to breast-feed during study
- subject who participated in another study within last 30 days or intends to participate in another study during this study
Key Trial Info
Start Date :
August 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 22 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03344861
Start Date
August 14 2017
End Date
March 22 2019
Last Update
January 13 2020
Active Locations (8)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
University of Colorado
Denver, Colorado, United States, 80045
3
Moffitt Cancer Center
Tampa, Florida, United States, 33612
4
Cancer Treatment Centers of America/Southeastern
Atlanta, Georgia, United States, 30265