Feasibility Study of Using Navigational Bronchoscopy to Perform PDT-Photofrin® in Unresectable Peripheral Lung Cancer
Condition: Non-small Cell Lung Cancer (NSCLC); Lung Metastasis
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis
Intervention: Porfimer sodium; Fiber optic
Intervention description: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.; A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
Intervention MeSH terms: Dihematoporphyrin Ether; Trioxsalen
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-small cell lung cancer; NSCLC; lung cancer; lung carcinoma; lung metastasis

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.
    

Eligibility 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