Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:43 PM
Ignite Modification Date:
2025-12-24 @ 12:43 PM
NCT ID:
NCT00526461
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Biopsy confirmed carcinoma in situ (CIS) or microinvasive bronchogenic non-small cell lung carcinoma
* May have squamous cell carcinoma, adenocarcinoma, or large cell carcinoma histology
* Stage 0 (CIS or microinvasive) disease, meeting all of the following criteria:
* Lesion must be radiographically occult and not definable by conventional CT scan of the chest
* Lesion may or may not be invisible on white light bronchoscopy, but is definable and photographable on laser-induced fluorescence emission (LIFE) bronchoscopy
* Biopsy of the lesion must indicate no evidence of invasion beyond cartilage on histopathology, but may be invasive through the basement membrane (microinvasive carcinoma)
* No evidence of major pulmonary vessel encasement on CT scan of the chest
PATIENT CHARACTERISTICS:
* Karnofsky performance status (PS) 50-100% OR ECOG PS 0-2
* Platelet count ≥ 100,000/mm\^3
* WBC ≥ 4,000/mm\^3
* Prothrombin time ≤ 1.5 times upper limit of normal (ULN)
* Total bilirubin ≤ 3.0 mg/dL
* Creatinine ≤ 3.0 mg/dL
* Alkaline phosphatase (hepatic) or SGOT ≤ 3 times ULN
* No porphyria or hypersensitivity to porphyrin or porphyrin-like compounds
* No severe chronic obstructive pulmonary disease, that in the opinion of the investigator, would preclude multiple bronchoscopies or partial central airway obstruction from mucous/debris formation
* Patients with underlying lung disease must be judged (by the principal investigator) able to withstand mucous or debris formation at the site of treatment
* No contraindications for bronchoscopy
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
* More than 4 weeks since prior and no concurrent chemotherapy or radiotherapy
* Prior therapy of any type (e.g., chemotherapy or radiotherapy) allowed for lung cancer
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00526461
Study Brief:
Protocol Section:
NCT00526461