CompletedPhase 1NCT03344861

Safety of PDT-Photofrin® Prior to Lung Surgery

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 in USA. Participation will last 4 months.

Checked against the public recordLast updated Jan 13, 2020 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1
U.S. locations8
SponsorConcordia Laboratories Inc.
01
Study overview

What this study is about

Purpose
Other
Study type
Interventional
Phase
Phase 1
Sponsor
Concordia Laboratories Inc.
Interventions being studied
Drug: Porfimer Sodium; Device: Fiber optic
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
03
Public criteria

Who may be able to participate

Inclusion Criteria: * 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 Criteria: * 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Cedars-Sinai Medical CenterLos Angeles, California
  • University of ColoradoDenver, Colorado
  • Moffitt Cancer CenterTampa, Florida
  • Cancer Treatment Centers of America/SoutheasternAtlanta, Georgia
  • AMITA Health Alexian Brothers Medical CenterElk Grove Village, Illinois
  • Dubois Medical CenterDuBois, Pennsylvania
  • UT MD Anderson Cancer CenterHouston, Texas
  • Providence Health & ServicesSpokane, Washington

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 13, 2020. Always confirm current availability with the study team.

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