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WithdrawnNCT01611584Updated Nov 13, 2014

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

A Phase 1 interventional study of ALA-induced Fluorescence in Lung Cancer in Normal and Malignant Tumors, sponsored by Dartmouth-Hitchcock Medical Center. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-11-13.

Sponsored by Dartmouth-Hitchcock Medical Center · Phase 1, Interventional, and Diagnostic

Why this study was withdrawn
PI left institution
Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

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

02

Conditions studied

  • Lung Cancer in Normal and Malignant Tumors

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Keywords

  • ALA
  • Florescence
  • Lung cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

Browse Lung Neoplasms studies →

Lead sponsor

Dartmouth-Hitchcock Medical Center is the lead sponsor of 472 studies on the registry; 68 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 20 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 1
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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

Interventions

  • DrugALA-induced Fluorescence

    ALA Dose- 20 mg/kg

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What researchers measure

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.

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

Secondary outcomes

  1. Determine Feasibility of fluorescence

    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

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Study locations

1 site
  • Dartmouth-Hitchcock Medical Center
    Lebanon, New Hampshire 03756, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01611584
Lead sponsor
Dartmouth-Hitchcock Medical Center
Responsible party
Sponsor
First posted
Jun 5, 2012
Start date
Jun 2010
Primary completion
Jul 2014
Completion
Jul 2014
Last update
Nov 13, 2014

Study contacts

Cherie P Erkmen, MD
principal investigator · Dartmouth-Hitchcock Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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