Clinical trial NCT06474975: Intra-SURGerY High-resolution Specimen PET/CT Imager for Margin Assessment in Early-stage Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Breast-conserving Surgery
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Primary outcomes:
measure: Evaluation of the accuracy to detect positive invasive margins in IDC patients
timeFrame: 1 month
Secondary outcomes:
measure: Evaluation of diagnostic performance of PET/CT in the detection of positive margins respect to gross pathology
timeFrame: 1 month
measure: Detection of malignant cells in resected lymph nodes and cavity shaves
timeFrame: 1 month
measure: Definition of optimal SUVmax cut-off
timeFrame: 1 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: European Institute of Oncology
name: Francesco Ceci
role: PRINCIPAL_INVESTIGATOR
References: