JPRN-jRCTs041220090
Completed
未知
Clinical study on the availability and safety of photodynamic diagnosis using 5-aminolevulinic acid during surgery for breast cancer patients
Kotani Haruru0 sites13 target enrollmentNovember 8, 2022
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Kotani Haruru
- Enrollment
- 13
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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\) The extent of the lesion is 2 cm or more by diagnostic imaging.
- •6\) No history of photosensitivity.
- •7\) Patients over 20 years old (at the time of signing the consent form)
- •8\) Patients with an ECOG Performance Status of 0 to 2 as determined at the time of enrollment
- •9\) Prior to enrollment, the latest 12\-lead ECG test is normal or has no abnormalities requiring treatment.
- •10\) Patients whose clinical laboratory values meet the following criteria (laboratory tests within 28 days prior to enrollment)
Exclusion Criteria
- •1\) Patients with any of the following history or complications
- •(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 100 mmHg or less or diastolic blood pressure of 60 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,
Outcomes
Primary Outcomes
Not specified
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