Intraoperative 3D ultrasound imaging for margin assessment in oral cancer surgery – a multicenter randomized clinical trial

Surgery is the primary treatment for oral cancer. The goal is a complete resection of the tumor with an adequate margin of healthy tissue around the tumor. Inadequate margins lead to a high risk of local cancer recurrence and the need for adjuvant therapies. Ex vivo imaging of the resected surgical specimen has been suggested for margin assessment and improved surgical results. Therefore, we have developed a novel 3D ultrasound imaging technique to improve the assessment of resection margins during surgery.

 

In this multicenter clinical trial, including leading surgical cancer centers from Europe, the USA, and Africa, we will explore whether 3D ultrasound can improve precision during cancer surgery. We will evaluate the accuracy of 3D ultrasound of the surgical specimen to assess the resection margins during oral cancer surgery. Patients undergoing surgical treatment for oral cancer will be enrolled and randomized to the intervention or control group. In the intervention group, the surgeons will have 3D ultrasound imaging available to assess the margins of the surgical specimen during the operation, this will allow for an immediate re-resection if deemed necessary. In contrast, the patients in the control group will undergo oral cancer surgery according to usual clinical practice without having 3D ultrasound available. The primary outcome is to compare the number of successful surgical treatments (free margins on final histopathology) in the two groups, while the secondary outcomes will compare the need for postoperative radiation therapy, recurrence rates, survival rates, quality of life, and the ability of surgeons to predict the resection margin on final histopathology rapport.

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The trial will be carried out by Daniel Julius Lauritzen, MD, under the supervision of ENT specialist and Associate Professor Tobias Todsen, MD, PhD, along with Biomedical Engineer Fatemeh Makouei, PhD.

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A grant by Sundhedsdonationer (Sygeforsikringen Danmark) supports the trial.