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. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 18, 2014