CLI and FAR for Intraoperative Margin Assessment

Summary

This study is a prospective, single arm interventional study to evaluate the diagnostic accuracy of intraoperative Cerenkov luminescence imaging (CLI) plus flexible autoradiography (FAR) using the LightPath® Imaging System for intraoperative tumour margin assessment compared to post-operative standard-of-care histopathology in women undergoing breast-conserving surgery for breast cancer.

Eligibility

Inclusion Criteria:

* • Female subjects ≥18 years of age with a diagnosis of invasive breast cancer scheduled to undergo BCS

  * Subjects who are able to give voluntary, written informed consent to participate in this study
  * Subjects who are able to understand this study and are willing to complete all the study assessments
  * Female subjects of childbearing age must have a negative pregnancy test (by Beta human chorionic gonadotrophin (β-HCG) qualitative analysis) or must have had a history of a surgical sterilisation or must give history of no menses in the past twelve months.

Exclusion Criteria:

* Subjects who have had surgery to the ipsilateral breast in the past 12 months
* Subjects who have had radiotherapy to the ipsilateral breast
* Subjects who have a known hypersensitivity to 18F-FDG
* Subjects who are pregnant or lactating
* Subjects who have an existing medical condition that would compromise their participation in the study

Conditions3

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