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

NCT ID: NCT06474975

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2026-07-31

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.

Conditions

Breast Cancer; Breast-conserving Surgery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

AURA 10 PET/CT

Intervention Type: DEVICE

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

Interventions

AURA 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

Intervention Type: DEVICE

Other Intervention Names

PET/CT specimen imager (AURA 10 PET/CT)

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

European Institute of Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francesco Ceci

Role: PRINCIPAL_INVESTIGATOR

European Institute of Oncology

Locations

European Institute of Oncology

Milan, , Italy

Countries

Italy

Central Contacts

Francesco Ceci, MD

Role: CONTACT

francesco.ceci@ieo.it

+390257489315

Francesco Mattana

Role: CONTACT

francesco.mattana@ieo.it

+390257489315

Facility Contacts

Francesco Ceci

Role: primary

Other Identifiers

L2-092

Identifier Type: -

Identifier Source: org_study_id