SPRAYDYE: a phase I/II randomised pilot study to assess the safety and feasibility of topically applied AKRO-6qcICG, a cathepsin-activatable fluorescent imaging agent, for real-time intraoperative resection margin assessment in breast-conserving surgery

Abstract

Introduction:

The incidence of tumour-positive surgical resection margins (TPRMs) after breast-conserving surgery (BCS) remains high, ranging from 10 to 40%. A TPRM, defined as breast cancer cells at the edge of the resected specimen at pathological evaluation, implies residual tumour and necessitates re-resection or boost radiation. To prevent these additional treatments, intraoperative near-infrared (NIR) fluorescence imaging with the topically applied, fluorescently quenched, cathepsin-activatable imaging agent AKRO-6qcICG might be used to detect residual cancer in the surgical cavity and guide additional resection during BCS. Cathepsins are proteolytic enzymes that are upregulated by breast cancer (associated) cells and therefore are suitable targets for tumour imaging. Ex vivo validation studies have shown that topically applied AKRO-6qcICG allows for clear breast cancer visualization and the detection of TPRMs. The proposed phase I/II study in healthy volunteers and breast cancer patients will assess the local and systemic safety of a single, topical dose of AKRO-6qcICG and its feasibility for intraoperative margin assessment during BCS.

Read the full publication here: Frontiers | SPRAYDYE: a phase I/II randomised pilot study to assess the safety and feasibility of topically applied AKRO-6qcICG, a cathepsin-activatable fluorescent imaging agent, for real-time intraoperative resection margin assessment in breast-conserving surgery