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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorEuropean Institute of Oncology

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

general or local contra-indication for BCS;

previous breast surgery;

inflammatory breast cancer;

radiotherapy of the ipsilateral breast;

Trial design

Treatments tested in this trial

  • AURA 10 PET/CT

Treatment groups

150 Participants
are divided into 1 treatment group

Sponsors and collaborators