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

• Status: Withdrawn
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dartmouth-Hitchcock Medical Center
• Treatments: Aminolevulinic Acid

Criteria

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