SURGYPET: Intra-SURGerY High-resolution Specimen PET/CT Imager for Margin Assessment in Early-stage Breast Cancer as Compared to Gross Pathology: a Prospective Non-inferiority Analysis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Evaluation of the accuracy to detect positive invasive margins in IDC patients
研究概览
简要总结
This study is a diagnostic open-label, prospective, single-arm non-inferiority clinical trial.
The primary endpoint is the accuracy to detect positive invasive margins in invasive ductal carcinoma (IDC) patients by high-resolution specimen Positron Emission Tomography/Computed Tomography (PET/CT) imaging.
详细描述
The rationale of this study is to examine the non-inferiority of intraoperative high-resolution specimen PET/CT imaging in early-stage breast cancer for the identification of all positive margins of the invasive component during Breast Cancer Surgery (BCS) as compared to standard-of-care gross pathology evaluation.
The PET/CT specimen imager is used to intraoperatively assess resection margins and histopathological findings of the breast tumor specimen are applied as the gold standard.
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
- •females with an age over 18 years;
- •confirmed breast cancer with indication to undergo BCS (stage I-II with tumor ≤2.5 in greatest dimension);
- •vacuum-assisted core breast biopsy is allowed for non-invasive tumors only;
- •able to understand treatment protocol and informed consent form;
- •estimated by the investigator to be compliant for study participation.
排除标准
- •general or local contra-indication for BCS;
- •previous breast surgery;
- •inflammatory breast cancer;
- •radiotherapy of the ipsilateral breast;
- •vacuum-assisted core breast biopsy for all patients with invasive tumors (vacuum-assisted core breast biopsy is allowed for patients with non-invasive tumors as long as the residual tumor size on mammogram is at least 1.0 cm);
- •pregnancy or lactation;
- •participation in other clinical studies with a radiation exposure of more than 1 mSv in the past year;
- •active bacterial, viral or fungal infection.
研究组 & 干预措施
Identification of positive margins with PET/CT specimen imager
Identification of all positive margins of the invasive component during BCS using PET/CT specimen imager
干预措施: AURA 10 PET/CT (Device)
结局指标
主要结局
Evaluation of the accuracy to detect positive invasive margins in IDC patients
时间窗: 1 month
Evaluation of intraoperative high-resolution specimen PET/CT imaging for the identification of all invasive positive margins during primary breast-conserving surgery (BCS) of invasive ductal carcinoma (IDC), as compared to perioperative gross pathology evaluation. Permanent pathology is used as the gold standard for margin assessment.
次要结局
- Evaluation of diagnostic performance of PET/CT in the detection of positive margins respect to gross pathology(1 month)
- Definition of optimal SUVmax cut-off(1 months)
- Detection of malignant cells in resected lymph nodes and cavity shaves(1 month)