EUCTR2010-023903-91-DEActive, not recruitingNot Applicable
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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Photocure ASA
- Enrollment
- 240
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •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
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 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
- •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
Investigators
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