Aminolaevulinic Acid Photodynamic Therapy of Cervical Persistent HPV Infection and Cervical Neoplasia

Cervical Intraepithelial Neoplasia Clinical Trial

Official title:

A Pilot Study of Aminolaevulinic Acid (ALA) Photodynamic Therapy (PDT) in Patients With Cervical Persistent High Risk HPV Infection or Cervical Intraepithelial Neoplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02304770
• Other study ID #: FDZJALA-201409
• Status: Completed
• Phase: Phase 2
• Start date: January 2015
• Est. completion date: January 2017

Study information

• Verified date: June 2019
• Source: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will examine the effect of aminolaevulinic acid (ALA) photodynamic therapy (PDT) of cervical precancerous lesions in women.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Premenopausal women, 25-50 years of age

2. Meet one of the 3 following conditions:

high-risk HPV-DNA persistently positive for at least 6 months, without CIN or higher grade lesions as verified by cervical biopsy within the last 3 months; CIN1 as verified by cervical biopsy within the last 3 months and high-risk HPV-DNA positive; CIN2/3 as verified by cervical biopsy within the last 3 months, with intense desire to retain the cervical structure or function

3. Satisfactory colposcopy examination (visibility of entire transformation zone and entire lesion margin ) and endocervical curettage negative

4. In good health condition as confirmed by past medical history, physical examination, electrocardiogram, laboratory tests and urinalysis on the screening and baseline evaluation within the last 4 weeks of the onset of the study

5. Meet the following conditions: pregnancy test negative; no pregnancy plan during the trial;no sexuality or reliable contraceptive measures taken since last menstruation to the onset of the study, agreeing to adopt reliable contraceptive measures during the study

6. Written informed consent signed

Exclusion Criteria:

1. Atypical glandular cells of undetermined significance (AGUS) or adenocarcinoma in situ (AIS) on cytology ,or malignant cells on cytology or histology, or other suspicion of either micro-invasive or invasive disease

2. Invasive carcinoma possibility or positive endocervical curettage on colposcopy

3. Severe pelvic inflammatory disease, severe cervicitis, or other severe gynaecological infection as per clinical examination

4. Undiagnosed vaginal bleeding

5. With allergic disease at present; known or suspected porphyria; known allergy to ALA or similar compounds

6. Evidence or history of clinically significant cardiovascular, endocrine, neurologic, pulmonary, hematological, immunological, psychiatric, metabolic disease or other serious diseases

7. Pregnancy or nursing

8. Therapeutic drug or other therapeutic measures applied on cervix or rectum within the last 2 weeks of the onset of the study

9. Participation in any clinical studies within the last 30 days

10. Subjects that the investigators judged to be not suitable to participate the study besides above

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia
• Cervical Persistent High Risk HPV Infection
• Communicable Diseases
• Infection
• Neoplasms
• Papillomavirus Infections

Intervention

Drug:
• Aminolaevulinic acid photodynamic therapy
Aminolaevulinic acid mediated photodynamic therapy

Locations

Country	Name	City	State
China	Women's Hospital School of Medicine Zhejiang University	Hangzhou	Zhejiang
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	The First Affliated Hospital with Nanjing Medical University	Nanjing	Jiangsu
China	The Obstetrics & Gynecology Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate	Based on histology	3 months after treatments
Primary	clearance of high risk HPV	proportion of patients with high risk HPV clearance	3 months after treatments