High-resolution XEOS AURA 10 PET-CT imaging of removed tumor tissue to compare with pathology and outcomes
A Multicentric, Observational, Post-marketing, Registry Study to Assess the Correlation of High-resolution Specimen PET-CT Imaging, Using the XEOS AURA 10 PET-CT, With the Histopathology Results and Long-term Outcome of Patients Undergoing Resective Cancer Surgery.
This registry will test whether high-resolution PET-CT scans of removed tumor tissue using the XEOS AURA 10 match pathology results and help guide care and long-term outcomes for adults having cancer surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 850 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | XEOS Medical Industry-sponsored |
| Locations | 1 site (Ghent) |
| Trial ID | NCT06970275 on ClinicalTrials.gov |
What this trial studies
This observational registry collects high-resolution PET-CT images made with the XEOS AURA 10 from resected tumor specimens and links those images to intraoperative impressions, histopathology, and follow-up outcomes. Both prospectively imaged patients and retrospectively included cases with prior successful specimen imaging may be entered if consent or notification requirements are met. Technical quality checks ensure included images contain at least part of the primary tumor and are interpretable. Analyses will describe concordance between specimen imaging and pathology and explore whether the imaging influenced clinical decisions or predicted long-term outcomes.
Who should consider this trial
Good fit: Adults scheduled for resective cancer surgery whose resected specimens are successfully imaged with the XEOS AURA 10 and who consent to use of their medical records are ideal candidates.
Not a fit: Patients under 18, pregnant or breastfeeding women, and cases where the specimen image is technically uninterpretable are not expected to benefit from inclusion in this registry.
Why it matters
Potential benefit: If successful, this approach could improve detection of residual tumor or margin status on surgical specimens and better inform postoperative care and surveillance.
How similar studies have performed: Specimen-level PET imaging is a relatively novel approach with some pilot data suggesting promising correlation with pathology, but large-scale prospective evidence is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria : All patients that were scheduled for resective surgery and for whom successful high-resolution PET-CT imaging was performed on their resected specimens using the AURA 10 PET-CT. Successful imaging means that the image contains at least a portion of the primary tumor, the radiotracer injection was correctly executed and there were no technical issues that lead to an uninterpretable PET-CT image. Or all patients that are scheduled for resective surgery and for whom high-resolution PET-CT imaging will be performed on their resected specimens using the AURA 10 PET-CT. Patients willing to provide informed consent for use of their relevant medical records. For retrospectively included patients with no further Long-Term Follow-Up (LTFU) data collection, a notification will be sent. Exclusion Criteria: * Under the age of 18 years at the time of resective surgery. * Women who are pregnant or breastfeeding.
Where this trial is running
Ghent
- AZ Maria Middelares — Ghent, Belgium (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.