A Proof of Principle Study of Aminolevulinic Acid (ALA) - Induced Fluorescence Detection in Resectable Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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The purpose of this trial is to measure ALA-induced fluorescence in both normal and malignant tissue.

Official Title
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A Proof of Principle Study of Aminolevulinic Acid (ALA) - Induced Fluorescence Detection in Resectable Non-Small Cell Lung Cancer

Conditions
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Lung Cancer in Normal and Malignant Tumors

Intervention / Treatment
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* Drug: ALA-induced Fluorescence


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion Criteria Patients (12 total patients with lung cancer) meeting eligibility criteria will be enrolled. Preoperative diagnosis of either presumed or documented non-small cell lung cancer. Tumor judged to be suitable for surgical resection based on preoperative evaluation of radiographic studies, pulmonary function tests, performance status and clinical judgment of surgeons at DHMC (Erkmen, Nugent) Age ≥ 18 years old. Population representative of our usual referral pattern including minority populations, women and those who are financially disadvantaged. Subjects capable of giving informed consent Exclusion Criteria: Pregnant Women Women who are breast feeding History of cutaneous photosensitivity Porphyria, hypersensitivity to porphyrins, photodermatosis Exfoliative dermatitis History of liver disease within the last 12 months Inability to comply with photosensitivity precautions associated with the study Inability to give informed consent AST, ALT, ALP or bilirubin levels greater than 2.5 times the normal limit at any time during the past 2 months Plasma creatinine in excess of 180 umol/L Women who are breast feeding History of cutaneous photosensitivity Porphyria, hypersensitivity to porphyrins, photodermatosis Exfoliative dermatitis History of liver disease within the last 12 months Inability to comply with photosensitivity precautions associated with the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALA<br>No arms for the trial. Participants will have proven or presumed lung cancer and will be assessed for participant by a research team member. | Drug: ALA-induced Fluorescence<br>* ALA Dose- 20 mg/kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ALA-induced fluorescence- lung cancer | Determine the relationship between ALA induced protoporphyrin IX (PplX) flourescence and histology in both normal and malignant tumors. | Participants will be followed for duration of the hospital stay, and up to 3 weeks after | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine Feasibility of fluorescence | Determine feasibility of integrating fluorescence detection into surgical pratice of resection for lung cancer. | Participants will be followed for the duration of their hospital study and up to 3 weeks after | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ALA, Florescence, Lung cancer