A Prospective Investigation of Near Infrared Fluorescence Imaging of Pelvic Lymph Nodes Using Indocyanine Green on the da Vinci Surgical System During Radical Prostatectomy and Pelvic Lymphadenectomy for Localized Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Intraoperative detection of fluorescence in pelvic lymphatic tissue by near-infrared imaging technology on the da Vinci Surgical System following direct injection of ICG into the prostate
研究概览
简要总结
This clinical trial studies diffuse optical imaging with indocyanine green solution in imaging pelvic lymph nodes in patients with stage II prostate cancer undergoing surgery. Indocyanine green solution is a special dye that can help doctors see the lymph nodes and blood vessels during surgery when visualized under diffuse optical imaging. Indocyanine green solution may improve the ability to detect lymph nodes and may lead to improved accuracy of lymph node removal.
详细描述
PRIMARY OBJECTIVES:
I. To determine the ability of indocyanine green (indocyanine green solution) (ICG) to highlight pelvic lymphatic tissue with fluorescence during robot assisted radical prostatectomy using near infrared fluorescence (diffuse optical imaging).
SECONDARY OBJECTIVES:
I. To evaluate the ability of this technique to improve lymph node yield, providing a potential therapeutic benefit to these patients by removing additional lymph nodes that may otherwise have been missed.
OUTLINE:
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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Stage 2, intermediate to high risk (per D'Amico criteria) localized prostate cancer with a prostate gland size =< 100 grams
- •Intermediate risk: prostate specific antigen (PSA) between 10-20, Gleason grade 7, or clinical stage T2b
- •High risk: PSA > 20 , Gleason grade >= 8, or clinical stage >= T2c
- •Life expectancy of at least 10 years
- •Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- •The subject must be able to comply with the study procedures
- •All subjects must have the ability to understand and the willingness to sign a written informed consent
排除标准
- •Subject has significant liver disease, cirrhosis or liver insufficiency with abnormal liver function tests, as total bilirubin > 1.5 x normal
- •Subject has significant liver disease, cirrhosis or liver insufficiency with abnormal liver function tests, as serum glutamic oxaloacetic transaminase (SGOT) > 2 x normal
- •Prior prostate surgery (i.e. transurethral resection of the prostate), or any prior abdominal or pelvic surgery, most specifically for surgeries that may have included any form of lymphadenectomy or anatomic changes
- •History of androgen deprivation therapy, any prior chemotherapy, or any prior radiation therapy to the pelvis
- •Subject has a previous history of adverse reaction or allergy to ICG, iodine, shellfish or iodine dyes
- •Subject in whom the use of x-ray dye or ICG is contraindicated including development of adverse events when previously or presently administered
- •Subject has any medical condition, which in the judgment of the investigator and/or designee makes the subject a poor candidate for the investigational procedure
- •The presence of medical conditions contraindicating general anesthesia or standard surgical approaches
研究组 & 干预措施
Diagnostic (ICG, diffuse optical imaging, surgery)
Patients receive indocyanine green transperineally and undergo diffuse optical imaging during robot-assisted laparoscopic radical prostatectomy with bilateral lymph node dissection using the da Vinci Robotic Surgical System.
干预措施: diffuse optical imaging (Other)
Diagnostic (ICG, diffuse optical imaging, surgery)
Patients receive indocyanine green transperineally and undergo diffuse optical imaging during robot-assisted laparoscopic radical prostatectomy with bilateral lymph node dissection using the da Vinci Robotic Surgical System.
干预措施: robot-assisted laparoscopic surgery (Procedure)
Diagnostic (ICG, diffuse optical imaging, surgery)
Patients receive indocyanine green transperineally and undergo diffuse optical imaging during robot-assisted laparoscopic radical prostatectomy with bilateral lymph node dissection using the da Vinci Robotic Surgical System.
干预措施: therapeutic lymphadenectomy (Procedure)
Diagnostic (ICG, diffuse optical imaging, surgery)
Patients receive indocyanine green transperineally and undergo diffuse optical imaging during robot-assisted laparoscopic radical prostatectomy with bilateral lymph node dissection using the da Vinci Robotic Surgical System.
干预措施: indocyanine green solution (Drug)
结局指标
主要结局
Intraoperative detection of fluorescence in pelvic lymphatic tissue by near-infrared imaging technology on the da Vinci Surgical System following direct injection of ICG into the prostate
时间窗: At the time of surgery
The ability to image lymph nodes prior to dissection will be estimated using means and standard errors for all observations as well as stratified by dose level and other relevant patient characteristics.
次要结局
- Quality of fluorescence as detected by near-infrared technology on the da Vinci Surgical System of lymphatic tissue at varying safe doses of ICG(At the time of surgery)
- Lymph node yield(At the time of surgery)
- Number of positive lymph nodes (nodes that contain cancer on final pathology)(At the time of surgery)