Development of New Diagnostic Method of Sentinel Lymph Nodes and Surgical Margins Using 5-Aminolevulinic Acid in Breast Cancer Patients.
Phase 1
- Conditions
- Breast cancer
- Registration Number
- JPRN-UMIN000018386
- Lead Sponsor
- Kyoto Prefectural University of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 130
Inclusion Criteria
Not provided
Exclusion Criteria
1. Porphyria 2. With history of hypersensitivity reaction for 5-aminolevulinic acid or porphyrin 3. For whom drugs that can cause photosensitivity disease is needed 4. Apparently or possibly pregnant or have desire to be come pregnant 5. Cases who physician judged improper to entry this trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To confirm the safety of 5-ALA and the performance of the measuring instrument. To check the matching rate between 5-ALA method and rapid or permanent pathological diagnosis of SLNs.
- Secondary Outcome Measures
Name Time Method To check the matching rate between 5-ALA method and rapid or permanent pathological diagnosis of surgical margins in breast conserving therapy.