Thoracic malignant tumors Thoracic malignant tumors
Conditions
Interventions
This is an interventional study to determine efficaty and safety of 5-ALA to detect thoracic malignant tumors during the surgery. 5-ALA 20 mg/kg will be orally administered 2-4 hours prior to surgery
D005456
Fluorescent Dyes
Sponsors
Sakao Yukinori
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pathological diagnosis or suspected clinical diagnosis of resectable/biopsyable lung malignancy 2) Age 20 years or older, less than 75 years 3) Performance status (PS) of 0 to 2 according to ECOG criteria 4) Lesion margins within 5 mm of the pleura on CT imaging 5) No previous respiratory surgery 6) (Women only) No pregnant, potentially childbearing or breastfeeding 7) No severe interstitial pneumonia or emphysematous changes in the lung 8) No active pneumonia 9) Laboratory values prior to the enrollment meet the following Total bilirubin <= 1.5mg/dl AST <= 100IU/L ALT <= 100IU/L Serum creatinine <= 1.2mg/dl 10)Written informed consent from the patient
Exclusion criteria
Exclusion criteria: 1) Co-existing heart failure or severe liver dysfunction 2) Dificulty of enrollment to this study with psychiatric disorders 3) Known hypersensitivity or history of hypersensitivity to porphyrin analogues 4) Porphyria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The diagnosis rate of 5-ALA for each resected section of organ - percentage of organs diagnosed as positive by 5-ALA, before resection, among organs diagnosed as malignant via pathological diagnosis (if there are multiple tissue specimens from the same organ, one positive specimen is considered as positive) If there are specimens from more than one organ (lung, pleura, and lymph nodes, etc.), then they will be evaluated individually by organ. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Consistency of 5-ALA fluorescence results from intraoperative to post-resection 2) Percentage of 5-ALA fluorecence positive (or negative) tissue specimens in cut surface among 5-ALA positive tissue specimens before-resection 3) Percentage of 5-ALA fluorecence positive (or negative) tissue specimens in cut surface among 5-ALA negative tissue specimens before-resection 4) From cut surface, percentage of 5-ALA fluorecence positive (or negative) tissue specimens among tissue specimens diagnosed as malignant via pathological diagnosis 5) Percentage of organs diagnosed as positive in cut surface by 5-ALA among organs diagnosed as malignant via pathological diagnosis 6) (Diagnosis for each resected section of organ) Percentage of organs diagnosed as negative by 5-ALA (either before resection or cut surface) among organs diagnosed as malignant via pathological diagnosis (if there are multiple tissue specimens from the same organ, all negative is considered as negative) 7) (Diagnosis for each resected section of organ) Percentage of organs diagnosed as positive or negative by 5-ALA (either before resection or cut surface) among organs diagnosed as not-malignant via pathological diagnosis 8) (Diagnosis for each resected section of organ) Percentage of organs pathologically diagnosed as malignant among organs considered as malignant via current normal procedure (observation under white light and palpation). 9) (Diagnosis for each resected section of organ) Percentage of organs pathologically diagnosed as not-malignant among organs considered as not-malignant via current normal procedure (observation under white light and palpation). 10) (Diagnosis for tissue specimen - continuous lesion will be counted as one specimen) Percentage of tissue specimens diagnosed as positive or negative by 5-ALA (either before resection or cut surface) among tissue specimens diagnosed as malignant via pathological diagnosis 11) (Diagnosis for tissue specimen) Percentage of tissue specimens d | — |
Contacts
Public ContactHitoshi Dejima
Department of Surgery, Teikyo University School of Medicine
Outcome results
None listed