Clinical trial · Interventional
A Proof of Principle Study of Aminolevulinic Acid (ALA) - Induced Fluorescence Detection in Resectable Non-Small Cell Lung Cancer
NCT01611584CI-TRIAL-00016058withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI left institution
Summary
Brief summary (as posted)
The purpose of this trial is to measure ALA-induced fluorescence in both normal and malignant tissue.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer in Normal and Malignant Tumors | Lung Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ALA-induced Fluorescence | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ALA
- 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.
- interventionNames
- Drug: ALA-induced Fluorescence
Primary outcomes (1)
- measure
- ALA-induced fluorescence- lung cancer
- timeFrame
- Participants will be followed for duration of the hospital stay, and up to 3 weeks after
- description
- Determine the relationship between ALA induced protoporphyrin IX (PplX) flourescence and histology in both normal and malignant tumors.
Secondary outcomes (1)
- measure
- Determine Feasibility of fluorescence
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.