Know Cancer

or
forgot password

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


Phase 1
18 Years
N/A
Not Enrolling
Both
Lung Cancer in Normal and Malignant Tumors

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

ALA-induced fluorescence- lung cancer

Outcome Description:

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

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Cherie P Erkmen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dartmouth-Hitchcock Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

D1046

NCT ID:

NCT01611584

Start Date:

July 2013

Completion Date:

December 2013

Related Keywords:

  • Lung Cancer in Normal and Malignant Tumors
  • ALA
  • Florescence
  • Lung cancer
  • Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756