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)
Inclusion Criteria:
- Patients with ectocervical CIN1 or CIN2 as verified by local pathology (biopsy)
obtained within the last month
- 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
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