MedTrace Logo

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

NCT06474975 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-06-26

No results posted yet for this study

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

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

Sponsors & Collaborators

  • European Institute of Oncology

    lead OTHER

Principal Investigators

  • Francesco Ceci · European Institute of Oncology

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06474975 on ClinicalTrials.gov