Using PET-CT imaging to assess surgical margins in breast cancer surgery

High-resolution PET-CT Imaging for Intraoperative Margin Assessment in Early-stage Breast Cancer: a Prospective Multicentric Interventional Clinical Study

This study is testing if using special PET-CT imaging during breast cancer surgery can help doctors make sure they remove all the cancerous tissue the first time, so patients don’t need to have more surgeries later.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: XEOS Medical (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 2 sites (Ghent, Vlaanderen and 1 other locations)
• Trial ID: NCT04999917 on ClinicalTrials.gov

What this trial studies

This study investigates the use of high-resolution PET-CT imaging during breast-conserving surgery to improve the identification of positive resection margins in patients with early-stage breast cancer. The goal is to reduce the need for reoperations by ensuring that all cancerous tissue is removed during the initial surgery. Patients will undergo standard surgical procedures while the imaging technology is applied to assess the tumor margins. The findings from the imaging will be compared to histopathological results to evaluate its effectiveness.

Who should consider this trial

Good fit: Ideal candidates for this study are females over 18 years old with confirmed early-stage breast cancer who are scheduled for breast-conserving surgery.

Not a fit: Patients with inflammatory breast cancer or those who have had previous breast surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the rate of reoperations for breast cancer patients by ensuring complete tumor removal during the first surgery.

How similar studies have performed: Other studies have shown promise in using advanced imaging techniques for surgical margin assessment, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* females with an age over 18 years;
* confirmed breast cancer (IDC, DCIS, ILC) with indication to undergo BCS;
* a minimal tumor size of 1.0 cm (in at least one dimension):

  * IDC group: assessed preoperatively on ultrasound;
  * DCIS subgroup: assessed preoperatively on mammogram;
  * ILC subgroup: assessed preoperatively on ultrasound;
  * NAT subgroup: assessed after NAT and before surgery on ultrasound;
* patients with IDC who have received NAT (i.e. chemotherapy, immunotherapy or endocrine therapy until eight weeks before BCS) may participate in the study;
* vacuum-assisted core breast biopsy is allowed in the DCIS subgroup 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 allocated to the IDC, ILC or NAT subgroup (vacuum-assisted core breast biopsy is allowed in the DCIS subgroup as long as the residual tumor size on mammogram is at least 1.0 cm);
* patients with DCIS only or ILC, and that have received NAT;
* blood glucose level over 200 mg/dL on the day of surgery;
* 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.

Where this trial is running

Ghent, Vlaanderen and 1 other locations

• Gynecology department — Ghent, Vlaanderen, Belgium (Recruiting)
• Gynecology Department — Ghent, Vlaanderen, Belgium (Recruiting)

Conditions Breast Cancer; Breast Cancer Invasive; Breast Cancer in Situ; PET-CT; margin assessment; breast conserving surgery