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

This study is not yet open for participant recruitment.
Verified February 2014 by Dartmouth-Hitchcock Medical Center
Sponsor:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01611584
First received: April 10, 2012
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Lung Cancer in Normal and Malignant Tumors
Drug: ALA-induced Fluorescence
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Proof of Principle Study of Aminolevulinic Acid (ALA) - Induced Fluorescence Detection in Resectable Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • ALA-induced fluorescence- lung cancer [ Time Frame: Participants will be followed for duration of the hospital stay, and up to 3 weeks after ] [ Designated as safety issue: No ]
    Determine the relationship between ALA induced protoporphyrin IX (PplX) flourescence and histology in both normal and malignant tumors.


Secondary Outcome Measures:
  • Determine Feasibility of fluorescence [ Time Frame: Participants will be followed for the duration of their hospital study and up to 3 weeks after ] [ Designated as safety issue: No ]
    Determine feasibility of integrating fluorescence detection into surgical pratice of resection for lung cancer.


Estimated Enrollment: 12
Study Start Date: May 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ALA
No arms for the trial. Participants will have proven or presumed lung cancer and will be assessed for participant by a research team member.
Drug: ALA-induced Fluorescence
ALA Dose- 20 mg/kg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01611584

Contacts
Contact: Cherie Erkmen, MD 800-639-6918 Cancer.Research.Nurse@Dartmouth.edu

Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Not yet recruiting
Lebanon, New Hampshire, United States, 03756
Principal Investigator: Cherie Erkmen, MD         
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: Cherie P Erkmen, MD Dartmouth-Hitchcock Medical Center
  More Information

No publications provided

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01611584     History of Changes
Other Study ID Numbers: D1046
Study First Received: April 10, 2012
Last Updated: February 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Dartmouth-Hitchcock Medical Center:
ALA
Florescence
Lung cancer

Additional relevant MeSH terms:
Neoplasms
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Aminolevulinic Acid
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014