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 January 2013 by Dartmouth-Hitchcock Medical Center
Sponsor:
Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01611584
First received: April 10, 2012
Last updated: May 16, 2013
Last verified: January 2013
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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: | July 2013 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (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: | May 16, 2013 |
| 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 May 19, 2013