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

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

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

Study Overview

• Status: Completed
• Conditions: Cervical Intraepithelial Neoplasia; Cervical Persistent High Risk HPV Infection
• Intervention / Treatment: Drug: Aminolaevulinic acid photodynamic therapy

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210036
      • The First Affliated Hospital with Nanjing Medical University
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu Hospital of Shandong University
  • Shanghai
    • Shanghai, Shanghai, China, 200011
      • The Obstetrics & Gynecology Hospital of Fudan University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • Women's Hospital School of Medicine Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: cervical persistent high risk HPV infection; Aminolaevulinic acid photodynamic therapy for the treatment of patients with cervical persistent high risk HPV infection	Drug: Aminolaevulinic acid photodynamic therapy; Aminolaevulinic acid mediated photodynamic therapy
EXPERIMENTAL: CIN 1 with high risk HPV infection; Aminolaevulinic acid photodynamic therapy for the treatment of patients with CIN 1 and high risk HPV infection	Drug: Aminolaevulinic acid photodynamic therapy; Aminolaevulinic acid mediated photodynamic therapy
EXPERIMENTAL: CIN 2/3; Aminolaevulinic acid photodynamic therapy for the treatment of patients with CIN 2/3	Drug: Aminolaevulinic acid photodynamic therapy; Aminolaevulinic acid mediated photodynamic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response Rate	Based on histology	3 months after treatments
clearance of high risk HPV	proportion of patients with high risk HPV clearance	3 months after treatments

Collaborators and Investigators

• Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2015
• Primary Completion (ACTUAL): January 1, 2017
• Study Completion (ACTUAL): January 1, 2017

Study Registration Dates

• First Submitted: November 23, 2014
• First Submitted That Met QC Criteria: November 26, 2014
• First Posted (ESTIMATE): December 2, 2014

Study Record Updates

• Last Update Posted (ACTUAL): June 12, 2019
• Last Update Submitted That Met QC Criteria: June 11, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Neoplasms by Histologic Type; Carcinoma; Neoplasms, Glandular and Epithelial; Disease Attributes; DNA Virus Infections; Tumor Virus Infections; Neoplasms; Carcinoma in Situ; Cervical Intraepithelial Neoplasia; Infections; Communicable Diseases; Papillomavirus Infections
• Other Study ID Numbers: FDZJALA-201409