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NOT YET RECRUITING
NCT06474975
NA

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

Sponsor: European Institute of Oncology

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2024-07

Completion Date

2026-07

Last Updated

2024-06-26

Healthy Volunteers

No

Interventions

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

Locations (1)

European Institute of Oncology

Milan, Italy