Breast Cancer, Breast-conserving Surgery
Conditions
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.
Interventions
DEVICEAURA 10 PET/CT
The 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
Sponsors
European Institute of Oncology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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; |
| 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; |
| 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 |
Countries
Italy
Contacts
Primary ContactFrancesco Ceci, MD
Backup ContactFrancesco Mattana
Outcome results
None listed