EUCTR2008-004604-31-FR进行中（未招募）1 期
A randomized phase II dose-finding study of hexaminolevulinate (HAL) photodynamic therapy (PDT) in patients with low-grade cervical intraepithelial neoplasia (CIN1).
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •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
排除标准
- •Non-satisfactory colposcopy examination including
- •onon-visibility of entire transformation zone including the squamocolumnar junction
- •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)
- •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.
研究者
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