Probe-based and Needle-based Confocal Laser Endomicroscopy During Gynaecological Examinations or Surgical Procedures for Gynecological Cancers : a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- The number of participants with adverse events, their type and severity.
研究概览
简要总结
The protocol aims at demonstrating the technical feasibility and safety of doing endomicroscopic imaging (both probe-based confocal laser endomicroscopy (pCLE) and needle-based confocal laser endomicroscopy, nCLE) during colposcopy, hysteroscopy, and surgical procedures (open surgery and laparoscopic robot assisted or not) to examine all pelvic tissues including cervix, uterus, adnexia, peritoneum, normal and pathologic aspect.
详细描述
This is a prospective study: about 75 patients (25 for each pathology) scheduled for a colposcopy or hysteroscopy examination or for a surgical treatment of the cervix/endocervix/endometrium/ovarian or tubal cancer will be enrolled. They will undergo the diagnostic consultation or surgical procedure, as per standard of care, plus an additional pCLE/nCLE procedure with the prototype probes, which will add between 5 and 10 minutes maximum to the examination.
The confocal miniprobe will be positioned against the surface of these organs or inside these same organs if the tumor is intratissular through a needle, and sequences will be acquired. Final diagnosis will be obtained for the patient, either through the result of the biopsies or through surgical pathology if the patient's lesion is surgically resected. Then imaging will be performed as well ex vivo on the resected specimens to provide additional stable imaging, and compare image quality to in vivo imaging.
The clinical endpoints of the study are:
- One or several Confocal Miniprobe designs optimized for use during colposcopy and hysteroscopy
- An optimized protocol of operations when using the designed Confocal Miniprobes during colposcopy and hysteroscopy as well as in the surgical setting, robotized or not (staining, use of accessories to hold the probes, etc...)
- A first atlas of endomicroscopic images obtained in the cervix, endocervix and endometrium
- The number, type and severity of recorded adverse events (to evaluate the safety).
Final objectives of CLE in gynecology:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patients scheduled for a colposcopy
- •Patients scheduled for a hysteroscopy
- •Patients scheduled for a surgical treatment for a suspected cervix/ endocervix/ endometrium lesion
- •18 years or older.
排除标准
- •Allergy to fluorescein
- •Previous life-threatening allergic reactions and known hypersensitivity
- •Pregnancy or breast-feeding
- •History of cardio-pulmonary disease (including bronchial asthma)
- •Restricted renal function
- •Patients under a beta-blockers treatment
研究组 & 干预措施
Confocal Laser Endomicroscopy (CLE)
The patient will undergo a 10 minutes endomicroscopy procedure to obtain real time microscopical images of healthy and malignant tissue of the targeted organs.
干预措施: Confocal Laser Endomicroscopy (CLE) (Device)
结局指标
主要结局
The number of participants with adverse events, their type and severity.
时间窗: 8 months
次要结局
- Number of interpretable images per organ and per pathology(8 months)