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

Withdrawn before enrolling · Phase 1

Conditions studied: Lung Cancer in Normal and Malignant Tumors

In brief

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

Key facts

Study ID

NCT01611584

Run by

Dartmouth-Hitchcock Medical Center

People needed

0

Starts

2010-06-01

Expected to finish

2014-07-01

Last updated by the study team

2014-11-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.