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

NCT01611584 | Withdrawn Phase 1 DMC

• 1 other identifier: D1046
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lung Cancer in Normal and Malignant Tumors

Keywords

ALA; Florescence; Lung cancer

Outcome Measures

Primary Outcomes (1)

• ALA-induced fluorescence- lung cancer

  Determine the relationship between ALA induced protoporphyrin IX (PplX) flourescence and histology in both normal and malignant tumors.

  Participants will be followed for duration of the hospital stay, and up to 3 weeks after

Secondary Outcomes (1)

• Determine Feasibility of fluorescence

  Participants will be followed for the duration of their hospital study and up to 3 weeks after

Study Arms (1)

ALA

EXPERIMENTAL

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

Interventions

ALA-induced Fluorescence DRUG

ALA Dose- 20 mg/kg

ALA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Cherie P Erkmen, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2012
• First Posted: June 5, 2012
• Study Start: June 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: November 13, 2014

Record last verified: 2014-11

Locations

US (1)