A randomized phase II dose-finding study of hexaminolevulinate (HAL) photodynamic therapy (PDT) in patients with low/moderate-grade cervical intraepithelial neoplasia (CIN1 or 2).

• Conditions: Patients with low/moderate-grade cervical intraepithelial neoplasia (CIN1 or 2).; MedDRA version: 13.1Level: LLTClassification code 10066238Term: Cervical low grade squamous intraepithelial lesionSystem Organ Class: 10038604 - Reproductive system and breast disorders; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2010-023903-91-SK
• Lead Sponsor: Photocure ASA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-16
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

•Patients with ectocervical CIN1 or CIN2 as verified by local pathology (biopsy) obtained within the last month
•Satisfactory colposcopy examination including:
ovisibility of entire transformation zone including the squamocolumnar junction and
ovisibility of entire lesion margin
•Negative endocervical os by colposcopy
•Colposcopical visible lesion at visit 2, before treatment
•Patients with an average sized uterine cervix (approximately 27mm diameter) suitable for application of the Klemcap
•Age 18 or above
•Written informed consent signed

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

•Previous treatment of CIN or invasive disease
•Lesion(s) extending to the vaginal vault
•Atypical glandular cells (AGC) or adenocarcinoma in situ (AIS) on cytology, malignant cells on cytology or histology or other suspicion of either micro-invasive or invasive disease
•Suspicion of endocervical disease on colposcopy
•Current severe pelvic inflammatory disease, severe cervicitis, or other severe gynaecological infection as per colposcopy and clinical examination
•Undiagnosed vaginal bleeding
•History of toxic shock syndrome
•Known or suspected porphyria
•Known allergy to hexaminolevulinate or similar compounds (e.g. methyl aminolevulinate or aminolevulinic acid)
•Pregnancy, or intention to become pregnant during the study period
•Nursing
•Childbirth or miscarriage within six weeks of enrolment
•Use of heart pacemaker
•Participation in other clinical studies either concurrently or within the last 30 days
•Risk of poor protocol compliance. Patient participation should be considered with respect to living far away from the hospital, plans for moving to another city/state, frequent travelling, planning to become pregnant, drug abuse/alcoholic, difficult working hours, family obligations, other illness (e.g. psychiatric), etc.
•Unwillingness to use adequate birth control (not abstinence) from screening until last PDT
•Patient is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified