Breast cancer
Conditions
Interventions
The dose of aminolaevulinic acid hydrochloride (20 mg/kg) is calculated based on the body weight at the time of admission. Dissolve the calculated dose in water and take it 2-4 hours before the start
Sponsors
Kotani Haruru
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically, breast cancer has been diagnosed. 2)The status of estrogen receptor, progesterone receptor, and HER2 does not matter. 3)It does not matter if there is an infiltrated part. 4)Standard surgery for primary breast cancer will be performed. 5)No history of photosensitivity. 6)Patients over 20 years old (at the time of signing the consent form) 7)Patients with an ECOG Performance Status of 0 to 2 as determined at the time of enrollment 8)Prior to enrollment, the latest 12-lead ECG test is normal or has no abnormalities requiring treatment. 9)Patients whose clinical laboratory values meet the following criteria (1) Platelet count 100,000/mm3 or more (2) Serum creatinine: Less than 1.5 times the upper limit of the institutional standard (3) AST (GOT): Less than 3.0 times the upper limit of the institutional standard (4) ALT (GPT): Less than 3.0 times the upper of the institutional standard (5) Serum bilirubin: Less than 1.5 times the upper limit of the institutional standard 10)Patients who are able to comply with the requirements of the study protocol 11)Patients who voluntarily consent to the document after understanding the contents of the consent explanation document
Exclusion criteria
Exclusion criteria: 1) Patients with any of the following history or com plications (1) Myocardial infarction (2) Congestive heart failure (3) Angina requiring treatment (4) Arrhythmia requiring treatment 2)Patients with serious complications (interstitial pneumonia, pulmonary fibrosis, uncontrolled hypertension, uncontrolled diabetes, etc.) 3)Patients with serious infections (including active tuberculosis) 4)Patients with systolic blood pressure of 90 mmHg or less or diastolic blood pressure of 50 mmHg or less at the time of enrollment 5)Patients with a history of hypotension 6)Pregnant women, female patients who are breastfeeding or may be pregnant, 7)Patients who are not willing to use contraception 8)Patients with hypersensitivity or history of porphyrin-related substances 9)Patients with porphyria 10)Cases in which it is difficult to participate in the study due to mental illness or psychiatric symptoms 11)Patients judged by the investigator to be inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Usefulness Calculate and compare sensitivity, specificity,Positive predictive value , Negative predictive value , and DOR for gross diagnosis alone and when added PDD observation 1)Sensitivity Percentage of specimens that were positive for optical examination among those that were pathologically diagnosed as positive for tumor 2)Specificity Percentage of specimens pathologically diagnose d as negative for tumors that were negative by photodynamic diagnosis. 3)Positive Predictive Value Percentage of specimens that were positive for tumor diagnosis among those that were positive for photodynamic diagnosis. 4)Negative Predictive Value Percentage of specimens that were pathologically diagnosed as having a negative tumor among those that were negative by photodynamic diagnosis. 5)Diagnostic Odds Ratio (DOR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety The following adverse events and side effects caused by the study drug 1) Photosensitivity and related events 2) Liver dysfunction (AST increase, ALT increase, blood bilirubin increase) 3) Hypotension: Hypotension that develops after administration of the study drug 4) Occurrence of adverse events causally related to the study drug 5) Occurrence of serious adverse events causally related to the study drug | — |
Contacts
Public ContactMinori Anto
Aichi Cancer Center Hospital
Outcome results
None listed