CIN
Conditions
Interventions
Case series:Different concentrations of aminolevulinic acid (ALA) were applied to the surface of the cervix. Fluorescence intensity testing was performed at different time points after application.
Sponsors
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co.,Ltd.
Eligibility
Sex/Gender
Female
Age
20 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Female, 20-65 years old; (2) Cervical cytology within 3 months is highly squamous intraepithelial lesion (HSIL) or pathological examination is cervical intraepithelial neoplasia (CIN); (3) Subjects were in good condition: According to the screening results within 1 week before the test, there was no history of heart, liver, kidney, digestive tract, nervous system, mental abnormalities and metabolic abnormalities; after a comprehensive physical examination showed ECG, blood pressure, heart rate, Respiratory conditions and laboratory tests, including blood, urine routines, and liver and kidney function tests, had no clinical abnormalities. (4) Women of childbearing age must meet the following conditions: pregnancy test is negative; there is no pregnancy plan during the trial; no sexual activity or reliable contraceptive measures are taken during the period from the end of the last menstrual period to the start of the test, and during the trial, agree to take reliable contraception ; (5) Voluntary participation and signing of informed consent.
Exclusion criteria
Exclusion criteria: (1) the significance of cytological examination of atypical gland cells (AGUS) is unknown, or malignant cells are observed in cytology, or patients with suspected micro-invasive and invasive diseases are suspected; (2) severe pelvic inflammation, cervical inflammation or other severe gynecological inflammation were found in the clinical examination; (3) undiagnosed vaginal bleeding; (4) those currently suffering from allergic diseases; suspected or known to have porphyrin disease or known to have a history of allergy to experimental and chemically similar drugs; (5) has a history of any clinical severe disease or cardiovascular system, endocrine system, nervous system, respiratory system disease or hematology, immunology, history of psychiatric disease and metabolic abnormalities, etc; (6) women during pregnancy and lactation; (7) drug abusers or those who have used soft drugs (e.g., marijuana) or hard drugs (e.g., cocaine, phenicyclohexidine, etc.) 3 months prior to the trial; (8) donation of blood or plasma (greater than 300 mL) within 1 month prior to the start of the trial; (9) those who have applied therapeutic drugs or other therapeutic measures to the local cervical area or rectum within 2 weeks prior to the start of the trial; (10) those who have participated in any drug clinical trial within 30 days prior to the start of the trial; (11) in addition to the above, the researchers judged that the participants were not suitable for this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| fluorescence intensity;AE; | — |
Countries
China
Contacts
Public ContactWenpei Bai, Yimin Cui
Peking University First Hospital
Outcome results
None listed