Surgical Margin Assessment Using Intra-operative High-resolution PET/CT in Patients With Cancers Referred to Surgical Resection, an Exploratory Pilot Study

Brief summary (registry, in English)

Reoperation is often required in surgical oncology because of positive resection margins and is associated with substantial physical, psychological, and economic consequences. Reoperation may also alter or delay the initiation of adjuvant therapy, potentially increasing the risk of local or distant recurrence. When re-resection is not feasible, a positive resection margin may necessitate additional treatment (e.g., radiation therapy or chemotherapy) that might otherwise have been avoided if clear margins had been achieved during the initial operation. Moreover, obtaining a negative margin during reoperation does not necessarily result in improved oncologic outcomes. Therefore, achieving negative margins intraoperatively is a key objective in oncologic surgery. The AURA 10 Specimen PET/CT imaging system, a novel technology developed by a Belgian company, has recently been introduced to the market. This system enables perioperative imaging of resected tumors within approximately 10 minutes, allowing prompt assessment of surgical margins. Preliminary studies have demonstrated the potential clinical utility of this technique in various cancers, including breast, head and neck, and prostate cancers (1-5). A recent multicenter study of patients with breast cancer reported a sensitivity of 91% and a specificity of 86% for assessing surgical margin status in invasive ductal carcinoma (IDC) (4). The aim of this study is to evaluate the clinical utility of perioperative specimen PET/CT imaging for surgical margin assessment and the feasibility of implementing this technology in routine clinical practice. The study will initially focus on breast cancer, head and neck cancer, soft tissue sarcomas, lung cancer, colorectal liver metastases, and hepatobiliary and pancreatic malignancies. Patients will be screened for study eligibility. Those who meet the eligibility criteria will be invited to participate and provide written informed consent. On the day of the scheduled operation, patients will receive an injection of the FDG radiotracer in the Department of Nuclear Medicine approximately 1 hour before surgery. They will then be transfered by authorized personnel to the operating room. Immediately after tumor resection, the surgical specimen will be imaged using the specimen PET/CT imager (AURA 10, Xeos); this process will take approximately 10 minutes. If the surgeon decides to re-excise additional tissue, that tissue will also be imaged. In addition, all resected lymph nodes will be imaged for research purposes only. The specimen will then be transferred to the histopathology laboratory for standard-of-care evaluation. During the operation, the results of specimen PET/CT imaging will not influence the surgeon's intraoperative decision-making. Subsequent clinical decisions will be based on the results of standard-of-care evaluations and the treating physician's clinical judgment. The final surgical margin status, as determined by the pathologist, will be collected for study purposes. Patients will receive treatment and follow-up in accordance with the standard of care, and relevant follow-up data will be collected.

What you commit to

• Study type: Interventional
• Planned participants: 250
• From 20 Jul 2026 to the primary completion date, Jul 2031
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

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Who cannot take part

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Who the study is looking for

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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