A Proof of Principle Study of Aminolevulinic Acid (ALA) - Induced Fluorescence Detection in Resectable Non-Small Cell Lung Cancer
NCT ID: NCT01611584
Last Updated: 2014-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2010-06-30
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
ALA-induced Fluorescence
ALA Dose- 20 mg/kg
Interventions
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ALA-induced Fluorescence
ALA Dose- 20 mg/kg
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Dartmouth-Hitchcock Medical Center
OTHER
Responsible Party
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Principal Investigators
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Cherie P Erkmen, MD
Role: PRINCIPAL_INVESTIGATOR
Dartmouth-Hitchcock Medical Center
Locations
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Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Countries
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Other Identifiers
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D1046
Identifier Type: -
Identifier Source: org_study_id