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

Phase 1

Withdrawn

• Conditions: Lung Cancer in Normal and Malignant Tumors
• Interventions: Drug: ALA-induced Fluorescence

• Registration Number: NCT01611584
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2012-04-10
• Study First Submitted QC: 2012-06-04
• Study First Posted: 2012-06-05
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-11
• Last Update Posted: 2014-11-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ALA	ALA-induced Fluorescence	No arms for the trial. Participants will have proven or presumed lung cancer and will be assessed for participant by a research team member.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States