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

NCT06474975 | Not Yet Recruiting

• 1 other identifier: L2-092
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Breast-conserving Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Evaluation of diagnostic performance of PET/CT in the detection of positive margins respect to gross pathology

  1 month

• Detection of malignant cells in resected lymph nodes and cavity shaves

  1 month

• Definition of optimal SUVmax cut-off

  1 months

Study Arms (1)

Identification of positive margins with PET/CT specimen imager

EXPERIMENTAL

Identification of all positive margins of the invasive component during BCS using PET/CT specimen imager

Device: AURA 10 PET/CT

Interventions

AURA 10 PET/CT 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

Also known as: PET/CT specimen imager (AURA 10 PET/CT)

Identification of positive margins with PET/CT specimen imager

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Francesco Ceci

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Ceci, MD

CONTACT

+390257489315; francesco.ceci@ieo.it

Francesco Mattana

CONTACT

+390257489315; francesco.mattana@ieo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: June 26, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 26, 2024

Record last verified: 2024-06

Locations

IT (1)