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

JRCT ID: jRCTs041220090

Registered date:08/11/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: breast cancer
• Date of first enrollment: 08/11/2022
• Target sample size: 13
• Study type: Interventional
• Intervention(s): 2-4 hours before the start of surgery, the dose of 5-aminorevphosphate 20 mg / kg should be calculated based on the body weight at the time of admission, and the dose should be dissolved in water before administration. The tumor and non-tumor areas are optically observed when the surgical specimen is removed during surgery .

Outcome(s)

Primary Outcome

(usefulness)
Verify that the Diagnostic Odds Ratio is 1 or greater.
(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,LDH increase,blood bilirubin increase,gamma GTP increase
3)Hypotension Hypotension that developed within 6 hours after the start of study drug administration
Occurrence of adverse events causally related to the study drug
Occurrence of serious adverse events causally related to the study drug

Secondary Outcome

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 diagnosed 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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kotani Haruru