Intra-SURGerY High-resolution Specimen PET/CT Imager for Margin Assessment in Early-stage Breast Cancer

N/ANot Yet RecruitingNCT06474975

European Institute of Oncology150 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

150

Conditions

Breast Cancer Breast-conserving Surgery

Interventions

AURA 10 PET/CTDEVICE

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

European Institute of Oncology

Milan, Italy

Outcomes

Primary Outcomes

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.

Time frame: 1 month

Secondary Outcomes

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;

Time frame: 1 month

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;

Time frame: 1 month

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

Time frame: 1 months

Central Contacts

Francesco Ceci, MD

CONTACT

+390257489315 francesco.ceci@ieo.it

Francesco Mattana

CONTACT

+390257489315 francesco.mattana@ieo.it

Data from ClinicalTrials.gov

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