An interventional study of XEOS AURA 10 in Oral Cancer, Osteosarcoma and Soft Tissue Sarcoma, sponsored by University Medical Center Groningen. Not yet recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-10.
Sponsored by University Medical Center Groningen · Not applicable, Interventional, and Diagnostic
The primary endpoint is the assessment of the clinical value of a novel high-resolution mobile PET-CT scanner for intraoperative margin assessment in oral squamous cell carcinoma, soft tissue sarcoma and osteosarcoma surgery. The predicted margin status will be correlated with the margin status determined with histopathology.
The ideal outcome in oncological surgery is resection of all tumor tissue with a margin of healthy tissue. However, positive surgical margins (PSMs) occur in up to 35% of the cases, depending on tumor type. The final margin status is only available five to seven days after surgery so that in case of a PSM, intensive adjuvant radiotherapy or chemotherapy is necessary. Despite adjuvant treatment, patients still have a significantly reduced overall survival. Therefore, the intraoperative identification of PSMs is paramount to enable surgical corrections and obtain a complete resection.
The investigators propose a dedicated intraoperative high-resolution PET-CT (positron emission tomography - computed tomography) imaging system for margin assessment of the excised specimen. The proposed specimen imaging system would combine the proven functional imaging capabilities of PET with the anatomical imaging info of CT, providing multi-modal information to determine whether tumor cells are present at the excision edges of the specimen. The tomographic images obtained can precisely demonstrate tumor extension along the x, y, and z axis, and the PET signal is not distorted by bone tissue. PET is the most sensitive medical imaging modality capable of detecting the picomolar concentrations of radiotracer, allowing to assess the presence of tumor cells within the specimen margins with high precision. Current standard PET-CT scanners have a spatial resolution between 3mm and 6mm, which is insufficient to accurately assess the excision margins of tumors. A specimen imaging system ideally should have a sub-millimeter resolution. The specimen PET system which will be used in this study is capable of this. The potential of intraoperative PET-CT has been shown in several tumor types, enabling the intraoperative identification of PSMs in prostatectomy and lumpectomy specimens.
1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.
This study's planned enrollment of 30 is below the median of 40 across 1,283 interventional studies indexed under Sarcoma.
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Subjects are intravenously administered with 2.0 MBq/kg 18F-FDG, standard tracer used to diagnose and stage the malignancy. After standard of care excision of the primary tumor, a high-resolution PET-CT imaging of the fresh surgical specimen will be performed.
Device: XEOS AURA 10
Surgery is performed according to standard of care. Directly after surgery, the surgical specimen is taken outside the operation theatre in a dedicated imaging room at the Department of Nuclear Medicine where high-resolution PET-CT imaging of the surgical specimen is performed.
Also known as: PET, PET/CT, High resolution PET/CT, Margin detection, Margin status
The primary endpoint is to determine the margin detection rates of a novel high-resolution mobile PET-CT for intraoperative margin assessment in OSCC, STS, and OS surgery.
Tumor positive and negative margin detection rates of the novel high-resolution mobile PET-CT scanner compared to standard of care pathology.
Time frame: Postoperatively i.e. 7-10 working days
Plan to share: Yes — Relevant research data on request
Supporting information: Study protocol, Csr
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University Medical Center Groningen