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.
Age ≥18 years.
Patient is confirmed with oral squamous cell carcinoma, soft tissue sarcoma or osteosarcoma.
Patient is indicated to undergo curative surgery of the primary tumor.
Patient is estimated compliant for study participation by the investigator.
Medical or psychiatric conditions that compromise the patient's ability to give informed consent;
Patient has previously received radiotherapy of the primary tumor region;
Patient has participated in other clinical studies with radiation exposure of more than 1 mSv in the past 12 months;
A blood glucose level over 200 mg/dL on the day of surgery.
Single group
XEOS AURA 10
DeviceSurgery 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.
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.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
