A dose finding study of hexaminolevulinate photodynamic therapy in patients with mild to moderate abnormal cell changes of the cervix
- Conditions
- Patients with low/moderate-grade cervical intraepithelial neoplasia (CIN1 or 2).Therapeutic area: Diseases [C] - Cancer [C04]MedDRA version: 14.0Level: LLTClassification code 10066238Term: Cervical low grade squamous intraepithelial lesionSystem Organ Class: 10038604 - Reproductive system and breast disorders
- Registration Number
- EUCTR2010-023903-91-CZ
- Lead Sponsor
- Photocure ASA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 240
Patients with ectocervical CIN1 or CIN2 as verified by local pathology (biopsy) obtained within the last two months before treatment
Satisfactory colposcopy examination including:
visibility of entire transformation zone including the squamocolumnar junction and
visibility 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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 230
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
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 verified by cytology obtained within the last two months before treatment
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 first three months after last treatment
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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method