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.
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;
general or local contra-indication for BCS;
previous breast surgery;
inflammatory breast cancer;
radiotherapy of the ipsilateral breast;
Single group
AURA 10 PET/CT
DeviceThe PET/CT specimen imager (AURA 10 PET/CT) is used to intraoperatively assess resection margins and histopathological findings of the breast tumor specimen are applied as the gold standard
Evaluation of the accuracy to detect positive invasive margins in IDC patients
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.
Evaluation of diagnostic performance of PET/CT in the detection of positive margins respect to gross pathology
determining the diagnostic performance of intraoperative high-resolution specimen PET/CT imaging and gross pathology to detect all positive margin;
Detection of malignant cells in resected lymph nodes and cavity shaves
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;
Definition of optimal SUVmax cut-off
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
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This trial is not recruiting at the moment. You can still explore other options:
