Clinical trial · Interventional
Intra-SURGerY High-resolution Specimen PET/CT Imager for Margin Assessment in Early-stage Breast Cancer
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
NCT06474975CI-TRIAL-00078280SURGYPETunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast-conserving Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AURA 10 PET/CT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Identification of positive margins with PET/CT specimen imager
- description
- Identification of all positive margins of the invasive component during BCS using PET/CT specimen imager
- interventionNames
- Device: AURA 10 PET/CT
Primary outcomes (1)
- measure
- Evaluation of the accuracy to detect positive invasive margins in IDC patients
- timeFrame
- 1 month
- description
- Evaluation of intraoperative high-resolution specimen PET/CT imaging for the identification of all invasive positive margins during primary breast-conserving surgery (BCS) of invasive ductal carcinoma (IDC), as compared to perioperative gross pathology evaluation. Permanent pathology is used as the gold standard for margin assessment.
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.