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

Dartmouth Health

Status and phase: Withdrawn; Phase 1

Conditions: Lung Cancer in Normal and Malignant Tumors

Treatments: Drug: ALA-induced Fluorescence

Study type: Interventional

Funder types: Other

Identifiers

NCT01611584

D1046

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

ALA

Experimental group

Description:

No arms for the trial. Participants will have proven or presumed lung cancer and will be assessed for participant by a research team member.

Treatment:

Drug: ALA-induced Fluorescence