Lung Cancer in Normal and Malignant Tumors
Conditions
Keywords
ALA, Florescence, Lung cancer
Brief summary
The purpose of this trial is to measure ALA-induced fluorescence in both normal and malignant tissue.
Interventions
DRUGALA-induced Fluorescence
ALA Dose- 20 mg/kg
Sponsors
Dartmouth-Hitchcock Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ALA-induced fluorescence- lung cancer | Participants will be followed for duration of the hospital stay, and up to 3 weeks after | Determine the relationship between ALA induced protoporphyrin IX (PplX) flourescence and histology in both normal and malignant tumors. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine Feasibility of fluorescence | Participants will be followed for the duration of their hospital study and up to 3 weeks after | Determine feasibility of integrating fluorescence detection into surgical pratice of resection for lung cancer. |
Countries
United States
Outcome results
None listed