Specimen PET-CT Imaging for Intraoperative Margin Assessment in Breast Cancer

Launched by XEOS MEDICAL · Aug 2, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging technique using a special type of scan called PET-CT to help doctors ensure they remove all of the breast cancer tissue during surgery. The goal is to see if this imaging can help identify any remaining cancer cells at the edges of the tissue that was removed, which is important because about 20-30% of women with early-stage breast cancer still need additional surgery if not all the cancer is taken out the first time.

To participate in the study, women over 18 years old who have been diagnosed with certain types of breast cancer and are planning to undergo breast-conserving surgery (where only the tumor and some surrounding tissue is removed) may be eligible. Participants will receive a small injection of a tracer before their surgery, which will allow the doctors to take detailed images of the tissue once it's removed. This imaging will help the surgeon decide if any extra tissue needs to be removed during the same surgery. After the surgery, participants will have a follow-up visit to check on their recovery and answer any questions about their experience in the study.

Gender

FEMALE

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.