A Randomized Phase II Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) in Patients With Low-grade Cervical Intraepithelial Neoplasia (CIN1)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 83
- 试验地点
- 5
- 主要终点
- Complete Response Rate
研究概览
简要总结
The study will examine the effect of HAL vs placebo photodynamic therapy of low-grade cervical precancerous lesions (dysplasia) in women.
详细描述
Low-grade cervical intraepithelial neoplasia (CIN1) is caused by persistent HPV infection and may worse case develop into cancer. In most cases both the virus infection and lesions (CIN1) regress spontaneously, but must be followed up with gynecological examinations to ensure normalization. If further persistent disease and worsening to precancerous lesions (CIN2-3), the usual treatment is surgery, where one removes the tissue in the cervix where the CIN lesions are.
In this research study we will evaluate a new non-surgical treatment for CIN1 using hexaminolevulinate (HAL) photodynamic therapy (PDT). HAL PDT is the combination of a medication and a specific type of light to activate the drug. HAL PDT selectively removes CIN lesions while preserving normal tissue, thus this may be an alternative to frequent gynecological consultations and local surgery that may have undesirable side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Satisfactory colposcopy examination
- •Negative endocervical canal by colposcopy
- •Ectocervical CIN1 as verified by local pathologist (biopsy).
- •Colposcopical visible lesion at visit 2, before photoactivation
- •Written Informed Consent signed
- •Age 18 or above
排除标准
- •Previous treatment of CIN or invasive disease or suspicion of either micro-invasive or invasive disease
- •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
- •Known allergy to hexaminolevulinate or similar compounds (e.g. methyl aminolevulinate or aminolevulinic acid)
- •Use of heart pacemaker
- •Pregnancy
- •Childbirth or miscarriage within six weeks of enrolment - Known
- •Participation in other "competitive" clinical studies either concurrently or within the last 30 days
- •Risk of poor protocol compliance
- •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.
研究组 & 干预措施
1
HAL suppository (single administration, HAL 100mg), laser illumination (50J/cm2)
干预措施: Hexaminolevulinate (HAL) (Drug)
2
Placebo suppository (single administration), laser illumination (50J/cm2)
干预措施: Placebo (Drug)
4
HAL ointment (5%, 100mg, single administration), LED diode illumination (50J/cm2)
干预措施: Hexaminolevulinate (HAL) (Drug)
5
Placebo ointment (single administration), no illumination
干预措施: Placebo (Drug)
结局指标
主要结局
Complete Response Rate
时间窗: 6 month
Based on histology, cytology and HPV status. "Complete response" is defined as normal pathology, normal cytology and negative HPV.
次要结局
- Eradication of HPV(6 months)
- Incidence of Patients With Adverse Events(3 months)