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

Primary Purpose

Lung Cancer in Normal and Malignant Tumors

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ALA-induced Fluorescence
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer in Normal and Malignant Tumors focused on measuring ALA, Florescence, Lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dartmouth-Hitchcock Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ALA

Arm Description

No arms for the trial. Participants will have proven or presumed lung cancer and will be assessed for participant by a research team member.

Outcomes

Primary Outcome Measures

ALA-induced fluorescence- lung cancer
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
Determine feasibility of integrating fluorescence detection into surgical pratice of resection for lung cancer.

Full Information

First Posted
April 10, 2012
Last Updated
November 11, 2014
Sponsor
Dartmouth-Hitchcock Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01611584
Brief Title
A Proof of Principle Study of Aminolevulinic Acid (ALA) - Induced Fluorescence Detection in Resectable Non-Small Cell Lung Cancer
Official Title
A Proof of Principle Study of Aminolevulinic Acid (ALA) - Induced Fluorescence Detection in Resectable Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Withdrawn
Why Stopped
PI left institution
Study Start Date
June 2010 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dartmouth-Hitchcock Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer in Normal and Malignant Tumors
Keywords
ALA, Florescence, Lung cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ALA
Arm Type
Experimental
Arm Description
No arms for the trial. Participants will have proven or presumed lung cancer and will be assessed for participant by a research team member.
Intervention Type
Drug
Intervention Name(s)
ALA-induced Fluorescence
Intervention Description
ALA Dose- 20 mg/kg
Primary Outcome Measure Information:
Title
ALA-induced fluorescence- lung cancer
Description
Determine the relationship between ALA induced protoporphyrin IX (PplX) flourescence and histology in both normal and malignant tumors.
Time Frame
Participants will be followed for duration of the hospital stay, and up to 3 weeks after
Secondary Outcome Measure Information:
Title
Determine Feasibility of fluorescence
Description
Determine feasibility of integrating fluorescence detection into surgical pratice of resection for lung cancer.
Time Frame
Participants will be followed for the duration of their hospital study and up to 3 weeks after

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cherie P Erkmen, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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