Intra-SURGerY High-resolution Specimen PET/CT Imager for Margin Assessment in Early-stage Breast Cancer
- Conditions
- Breast CancerBreast-conserving Surgery
- Interventions
- Device: AURA 10 PET/CT
- Registration Number
- NCT06474975
- Lead Sponsor
- European Institute of Oncology
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 150
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Identification of positive margins with PET/CT specimen imager AURA 10 PET/CT Identification of all positive margins of the invasive component during BCS using PET/CT specimen imager
- Primary Outcome Measures
Name Time Method Evaluation of the accuracy to detect positive invasive margins in IDC patients 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.
- Secondary Outcome Measures
Name Time Method Evaluation of diagnostic performance of PET/CT in the detection of positive margins respect to gross pathology 1 month determining the diagnostic performance of intraoperative high-resolution specimen PET/CT imaging and gross pathology to detect all positive margin;
Definition of optimal SUVmax cut-off 1 months determining the optimal SUVmax cut-off in intraoperative high-resolution specimen PET/CT imaging for the correct detection of malignant vs. non-malignant tissues, using pathology results as standard-of-reference
Detection of malignant cells in resected lymph nodes and cavity shaves 1 month exploring the ability of intraoperative high-resolution specimen PET/CT imaging to detect the presence of malignant cells in resected lymph nodes and cavity shaves;
Trial Locations
- Locations (1)
European Institute of Oncology
🇮🇹Milan, Italy