Fluorescent Guided Surgery in Penile Carcinoma Using Cetuximab-800IRDyeCW
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Phase 1: Compare the spot to background ratio for tumor positive and tumor negative margins.
研究概览
简要总结
The main treatment modality for Penile Squamous Cell Carcinoma (PSCC) is surgery with curative intent. In organ sparing surgery a tumor-positive margin of up to 36% exist. Tumor-positive surgical margins are an independent risk factor for local recurrence, which has been reported to be up to 18%. Tumor-positive margins always lead to extra, penile sparing surgery, which leads to longer hospitalization, higher exposure to anesthetic interventions and a worse psychological outcome.
Currently, no intraoperative imaging technique that provides real time feedback for resection margins exists in PSCC. Molecular fluorescence-guided Surgery (MFGS) using targeted near-infrared (NIR) optical contrast agents like for example Cetuximab-800CW is a promising technique to accommodate this need. Epidermal Growth Factor Receptor (EGFR) is overexpressed in PSCC and has safely and successfully been used as target for molecular imaging, particularly for assessment for tumor margins in head and neck squamous cell carcinoma (ICON study, UMCG1).
详细描述
The main treatment modality for Penile Squamous Cell Carcinoma (PSCC) is surgery with curative intent. There is no difference in mortality between organ sparing surgery and radical surgery, and for optimal cosmetic and functional results small resection (3-5mm) margins are used. In organ sparing surgery a tumor-positive margin of up to 36% exist. Tumor-positive surgical margins are an independent risk factor for local recurrence, which has been reported to be up to 18%. These local remaining tumor depositions can be continuous or discontinuous from the main tumor, which makes it hard for the treating surgeon to recognize them clinically. Tumor-positive margins always lead to extra, penile sparing surgery, which leads to longer hospitalization, higher exposure to anesthetic interventions and a worse psychological outcome.
Currently, no intraoperative imaging technique that provides real time feedback for resection margins exists in PSCC. Molecular fluorescence-guided Surgery (MFGS) using targeted near-infrared (NIR) optical contrast agents like for example Cetuximab-800CW is a promising technique to accommodate this need. Epidermal Growth Factor Receptor (EGFR) is overexpressed in PSCC and has safely and successfully been used as target for molecular imaging, particularly for assessment for tumor margins in head and neck squamous cell carcinoma (ICON study, UMCG1).
Objectives:
The purpose of the current study is to determine the feasibility of using MFGS using Cetuximab-800CW as an intraoperative margin assessment tool for penile carcinoma.
Study design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy confirmed diagnosis of primary or recurrent PSCC and scheduled to undergo surgical resection of primary or recurrent tumor with or without (sentinel) lymph node procedure as decided by the Urology Department of the UMCG.
- •Age ≥ 18 years
- •Written informed consent
- •Adequate potential for follow-up
排除标准
- •Medical or psychiatric conditions that compromise the patient's ability to give informed consent
- •Concurrent uncontrolled medical conditions
- •Received an investigational drug within 30 days prior to the dose of cetuximab-800CW
- •Tumors at sites of which the surgeon would assess that in vivo imaging would not be feasible
- •Had within 6 months prior to enrollment: myocardial infarction, cerebrovascular accident, uncontrolled cardiac heart failure, significant liver disease, unstable angina
- •Inadequately controlled hypertension with or without current antihypertensive medications
- •History of infusion reactions to cetuximab or other monoclonal antibody therapies
- •Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females)
- •Lab values that in the opinion of the primary surgeon would prevent surgical resection
- •Patients receiving Class Ia (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
- •Magnesium, potassium and calcium deviations that might lead to cardiac rhythm (grade II or higher deviations by CTCAE)
- •Life expectancy < 12 weeks
- •Karnofsky performance status < 70%
研究组 & 干预措施
Phase 1: 75mg Cetuximab and 15mg Cetuximab-IRDye800CW
Patients receive 75mg of Cetuximab, followed by 15mg Cetuximab-IRDye800CW I.V. two days prior to surgery.
干预措施: Cetuximab-IRDye800CW (Drug)
结局指标
主要结局
Phase 1: Compare the spot to background ratio for tumor positive and tumor negative margins.
时间窗: 2 years
The main purpose is to establish the intraoperative use of cetuximab-800CW as a reliable marker for residual tumor in resection margins after surgical removal of PSCC. The objective is to establish the feasibility of cetuximab-800CW fluorescence at the dose of 75/15 mg predose/dose combination as a marker for a tumor positive resection by comparing the spot to background ratios for tumor positive and tumor negative margins. A tumor to background ratio of \>2.0 is aspired.
次要结局
- Quantification of sensitivity and positive predictive value of cetuximab-800CW in PSCC(2 years)
研究者
Max J.H. Witjes
Prof. dr.
University Medical Center Groningen