A randomized phase II dose-finding study of hexaminolevulinate (HAL) photodynamic therapy (PDT) in patients with low-grade cervical intraepithelial neoplasia (CIN1).
- Conditions
- ow grade cervical intraepithelial neoplasia (CIN)MedDRA version: 9.1Level: LLTClassification code 10066238Term: Cervical low grade squamous intraepithelial lesion
- Registration Number
- EUCTR2008-004604-31-FR
- Lead Sponsor
- Photocure ASA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 0
•Satisfactory colposcopy examination including:
ovisibility of entire transformation zone including the squamocolumnar junction and
ovisibility of entire lesion margin
•Negative endocervical canal by colposcopy.
•Ectocervical CIN1 as verified by local histology (biopsy).
•Colposcopical visible lesion at visit 2, before photoactivation.
•Written Informed Consent signed
•Age 18 or above
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•Non-satisfactory colposcopy examination including
onon-visibility of entire transformation zone including the squamocolumnar junction
or
onon-visibility of entire lesion margin
•Previous treatment of CIN or invasive disease or suspicion of either micro-invasive or invasive disease
- Persistant CIN1 for more than 18 months
•Malignant cells on cytology or histology
•Atypical glandular cells (AGC) or adenocarcinoma in situ (AIS) on cytology
•Suspicion of endocervical disease on colposcopy
•Current pelvic inflammatory disease, cervicitis, or other gynecological infection as per colposcopy and clinical examination
•Known or suspected porphyria
•Patients who have received one or more shots of a prophylactic HPV vaccine (e.g.Gardasil or Cervarix)
•Known allergy to hexaminolevulinate or similar compounds (e.g. methyl aminolevulinate or aminolevulinic acid)
•Pregnancy
•Nursing
•Childbirth or miscarriage within six weeks of enrolment
•Participation in other competitive” 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 traveling, planning to become pregnant, drug abuse/alcoholic, difficult working hours, family obligations, other illness (e.g. psychiatric), etc.
•Not willing to use adequate birth control from screening until last PDT
•Subject 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