Photodynamic therapy with 20% 5‑amino‑ketovalerate and 630 nm red light for CIN3
Efficacy and Safety of Photodynamic Therapy for Cervical Intraepithelial Neoplasia 3(CIN3):A Multicenter Prospective Cohort Study
This will test whether photodynamic therapy using 20% 5‑amino‑ketovalerate plus 630 nm red light can clear CIN3 lesions in women.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Peking University Third Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT07009327 on ClinicalTrials.gov |
What this trial studies
This single-center interventional study at Peking University Third Hospital delivers topical 20% 5‑amino‑ketovalerate followed by 630 nm red‑light activation to treat biopsy-confirmed CIN3 lesions in a real‑world clinical setting. Eligible participants have fully visible lesion boundaries in a type 1 or 2 transformation zone and an ECC that does not indicate high‑grade disease, while those with suspected invasive cancer, glandular involvement, TCT HSIL, porphyria, light allergy, or severe comorbidities are excluded. Investigators will monitor lesion response and safety with colposcopy, cytology, and scheduled follow-up visits, though detailed endpoints and follow-up timing are not provided. The approach aims to test a non‑surgical, fertility‑sparing treatment option and document its tolerability in routine care.
Who should consider this trial
Good fit: Ideal candidates are women with biopsy‑confirmed CIN3 whose lesions are fully visible in a type 1 or 2 transformation zone and whose ECC does not show high‑grade disease, without porphyria or photosensitivity.
Not a fit: Patients with suspected or confirmed invasive cancer, glandular/endocervical involvement, TCT HSIL, porphyria or allergy to light, severe medical comorbidities, or lesions that are not fully visible or are in a type 3 transformation zone are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this treatment could provide a less invasive, fertility‑sparing alternative to excisional surgery for women with CIN3.
How similar studies have performed: Small trials and case series of photodynamic therapy for CIN, including CIN2/3, have reported promising lesion clearance and acceptable safety but large randomized trials remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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；
Where this trial is running
Beijing
- Peking Unniversity Third Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Qin Han
- Email: Lmlfe_lynn@126.com
- Phone: 13810632686
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.