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.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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.
* Written informed consent.
Exclusion Criteria:
* 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.
* Pregnancy or lactation.
Primary outcome measure(s)
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. — Postoperatively i.e. 7-10 working days Tumor positive and negative margin detection rates of the novel high-resolution mobile PET-CT scanner compared to standard of care pathology.
Trial sites (1)
Facility
City
Region
Status
University Medical Center Groningen
Groningen
Netherlands
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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