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

SURGYPET: Intra-SURGerY High-resolution Specimen PET/CT Imager for Margin Assessment in Early-stage Breast Cancer as Compared to Gross Pathology: a Prospective Non-inferiority Analysis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer; Breast-conserving Surgery
• Intervention / Treatment: Device: AURA 10 PET/CT

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francesco Ceci, MD; Phone Number: +390257489315; Email: francesco.ceci@ieo.it
• Study Contact Backup: Name: Francesco Mattana; Phone Number: +390257489315; Email: francesco.mattana@ieo.it

Study Locations

• Italy
  • Milan, Italy
    • European Institute of Oncology
    • Contact: Francesco Ceci

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: 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; Other Names: PET/CT specimen imager (AURA 10 PET/CT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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;	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;	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	1 months

Collaborators and Investigators

• Sponsor: European Institute of Oncology
• Investigators: Principal Investigator: Francesco Ceci, European Institute of Oncology

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: June 20, 2024
• First Submitted That Met QC Criteria: June 20, 2024
• First Posted (Actual): June 26, 2024

Study Record Updates

• Last Update Posted (Actual): June 26, 2024
• Last Update Submitted That Met QC Criteria: June 20, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: L2-092

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No