Intraoperative diagnosis with 5-ALA: efficacy and safety for thoracic malignant tumor surgery

JRCT ID: jRCTs031210545

Registered date:12/01/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Thoracic malignant tumors
• Date of first enrollment: 04/04/2022
• Target sample size: 30
• Study type: Interventional
• Intervention(s): 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 using approved methods for bladder cancer. The fluorescence visibility will be evaluated using a fluorescence imaging system. Suregery and pathological diagnoses will be performed based on the current practice. Vital signs and lab tests on day 0 (the day of the surgery), 1, 3 and 5, and lab tests on day 28 will be performed after the surgery lab test on day 28to check adverse events.

Outcome(s)

Primary Outcome

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 Outcome

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 diagnosed as positive or negative by 5-ALA (either before resection or cut surface) among tissue specimens pathologically diagnosed as not-malignant
12) (Diagnosis for tissue specimen) Percentage of tissue specimens pathologically diagnosed as malignant among tissue specimens diagnosed as positive by 5-ALA (either before resection or cut surface)
13) (Diagnosis for tissue specimen) Percentage of tissue specimens pathologically diagnosed as not-malignancy among tissue speciments diagnosed as positve by 5-ALA (either before resection or cut surface)
14) (Diagnosis for tissue specimen) Percentage of tissue specimens pathologically diagnosed as not-malignany among tissue specimens diagnosed as negative by 5-ALA (either before resection or cut surface)
15) (Diagnosis for tissue specimen) Percentage of tissue specimens pathologically diagnosed as malignant among tissue specimens considered as malignant via current normal procedure (observation under white light and palpation)
16) (Diagnosis for tissue specimen) Percentage of tissue specimens pathologically diagnosed as not-malignant among tissue specimens considered as not-malignant via current normal procedure (observation under white light and palpation)
17) Comparison of measured tumor size among 5-ALA diagnose (either before resection or cut surface), pathological diagnose and contrast-enhanced CT diagnose
18) Metastated lymph nodes diagnose - comparison between percentages of metastasis positive by 5-ALA (either before resection or cut surface) and PET among pathologically diagnosed as positive lymph nodes
19) Characteristics of 5-ALA positive or negative tissues specimens (either before resection or cut surface) - the location, histological type, presence of pleural invasion, and distance from the visceral pleura
20) Exploratory analysis of factors affecting 5-ALA results (either before resection or cut surface), including patient backgrounds, lung backgrounds or histology

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 75age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Sakao Yukinori