Our recent paper, “A handheld device for intra-cavity and ex vivo fluorescence imaging of breast conserving surgery margins with 5-aminolevulinic acid,” was published in the Biomedical Engineering Journal (June 2024).
Visualization of cancer during breast conserving surgery (BCS) remains challenging; the BCS reoperation rate is reported to be 20-70% of patients. An urgent clinical need exists for real-time intraoperative visualization of breast carcinomas during BCS. We previously demonstrated the ability of a prototype imaging device to identify breast carcinoma in excised surgical specimens administration following 5-aminolevulinic acid (5-ALA) administration. However, this prototype device was not designed to image the surgical cavity for remaining carcinoma after the excised lumpectomy is removed. A new handheld fluorescence (FL) imaging prototype device, designed to image both excised specimens and within the surgical cavity, was assessed in a clinical trial to evaluate its clinical utility for first-in-human, real-time intraoperative imaging during index BCS.
This pilot study has demonstrated the detection of a grossly occult positive margin intraoperatively. We were also able to distinguish healthy breast tissues based on their appearance and demonstrated the detection of red FL tumours in sectioned lumpectomies following administration of 5-ALA. Imaging breast surgical cavities for the first time with the Eagle device has elucidated the strengths and weaknesses of the prototype device.