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Trial Title:
Intra-SURGerY High-resolution Specimen PET/CT Imager for Margin Assessment in Early-stage Breast Cancer
NCT ID:
NCT06474975
Condition:
Breast Cancer
Breast-conserving Surgery
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
AURA 10 PET/CT
Description:
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
Arm group label:
Identification of positive margins with PET/CT specimen imager
Other name:
PET/CT specimen imager (AURA 10 PET/CT)
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.
Detailed 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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
European Institute of Oncology
Address:
City:
Milan
Country:
Italy
Contact:
Last name:
Francesco Ceci
Start date:
July 2024
Completion date:
July 2026
Lead sponsor:
Agency:
European Institute of Oncology
Agency class:
Other
Source:
European Institute of Oncology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06474975
