Efficacy and Safety of Photodynamic Therapy for CIN3

Peking University

Status: Enrolling

Conditions: Precancerous Cervical Lesion

Treatments: Procedure: ALA-PDT

Study type: Interventional

Funder types: Other

Identifiers

NCT07009327

2022YFB3604704 (Other Grant/Funding Number)

PDT-CIN3

Details and patient eligibility

About

To investigate the efficacy and safety of photodynamic therapy (20% 5-amino-ketovalerate 630nm red light) in the treatment of cervical intraepithelial neoplasia 3(CIN 3)in women in the real world

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• CIN3, photodynamic therapy was required,
• type 1 2 transformation area, colposcopy was sufficient
• the lesion boundary was completely visible
• The ECC did not indicate high-grade lesions

Exclusion criteria

• coexistence or suspicion of cancer;
• TCT HSIL
• involving glands
• Porphyria patients, or suspected allergic to red and blue light.
• severe medical comorbidities；

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

ALA-PDT

Other group

Description:

Patients choose PDT to treat the disease

Treatment:

Procedure: ALA-PDT