Clinical study of photodynamic diagnosis during surgery with 5-ALA in breast cancer patients

Not Applicable

• Conditions: breast cancer

• Registration Number: JPRN-jRCTs041220090
• Lead Sponsor: Kotani Haruru

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-11-08
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 13

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)
(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
12) Patients who are able to comply with the requirements of the study protocol
13) Patients who voluntarily consent to the document after understanding the contents of the consent explanation document

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,
7)Patients who are not willing to use contraception
8) Patients with hypersensitivity or history of porphyrin-related substances
9)Patients with porphyria
10)Drugs known to cause photosensitivity: Patients receiving foods containing St. John's Wort, such as tetracycline antibiotics, sulphonamides, new quinolone antibacterial agents, etc.
11)Cases in which it is difficult to participate in the study due to mental illness or psychiatric symptoms
12)Patients judged by the investigator to be inappropriate

Study & Design

• Study Type: Interventional
• Study Design: Not specified