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

European Institute of Oncology

Status

Not yet enrolling

Conditions

Breast Cancer

Breast-conserving Surgery

Treatments

Device: AURA 10 PET/CT

Study type

Interventional

Funder types

Other

Identifiers

NCT06474975

L2-092

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.