Lung Cancer in Normal and Malignant Tumors Clinical Trial
Official title:
A Proof of Principle Study of Aminolevulinic Acid (ALA) - Induced Fluorescence Detection in Resectable Non-Small Cell Lung Cancer
The purpose of this trial is to measure ALA-induced fluorescence in both normal and malignant tissue.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | July 2014 |
| Est. primary completion date | July 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| United States | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
| Lead Sponsor | Collaborator |
|---|---|
| Dartmouth-Hitchcock Medical Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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 | No |