An observational study in Prostate Cancers, Breast Cancer and Head and Neck Cancer, sponsored by XEOS Medical. Recruiting at 5 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by XEOS Medical · Observational
This registry study aims to evaluate the effectiveness and clinical impact of specimen PET-CT imaging by analyzing the correlation between specimen PET-CT images, intraoperative interpretations, and histopathological findings. Additionally, it assesses how these imaging insights influence clinical decision-making and long-term patient outcomes. Through this comprehensive analysis in a real-world setting, the study seeks to generate valuable insights that can enhance specimen evaluation processes and ultimately improve patient care.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.
This study's planned enrollment of 850 is above the median of 200 across 1,179 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →XEOS Medical is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who are routinely scheduled or underwent resective surgery and for whom high-resolution PET-CT imaging is or was performed on their resected specimens, using the AURA 10 PET-CT, may participate in this study.
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:
To assess the correlation between the specimen PET-CT images and final histopathological examination of the specimen.
The concordance rate between the specimen PET-CT images and final histopathological examination of the specimen.
Time frame: Perioperative
To assess the correlation between the intra-operative interpretation of specimen PET-CT images and histopathological examination of the specimen and its impact on clinical decision-making.
The concordance rate between the specimen PET-CT image interpretation and histopathological examination of the specimen. This will include sensitivity, specificity, positive predictive value, and negative predictive value of the intra-operative interpretation of specimen PET-CT images compared to final histopathological examination. The concordance rate of the clinical decisions made based on specimen PET-CT images with the clinical decisions supported by final histopathological examination (e.g. additional resection during surgery, follow-up treatment strategy, etc).
Time frame: Perioperative
To assess the correlation between long-term follow-up clinical outcome and specimen PET-CT imaging findings.
The incidence of biochemical, local, regional and distant recurrence rate at 1, 2 and 3 years of follow-up. The measurement of functional outcome at 1, 2 and 3 years of follow-up.
Time frame: From surgery to 3 years long term follow-up
To evaluate the influence of neoadjuvant treatment (NAT) on PET radiotracer uptake in specimen PET-CT imaging.
The measurement of PET radiotracer uptake (in MBq/mL) in specimen PET-CT images, comparing patients with different neoadjuvant treatments and those who did not receive neoadjuvant treatment.
Time frame: Perioperative
To investigate whether preoperatively available information (such as tumor subtype, anatomical location, tumor biology, size, grade or TNM classification) as well as intra-operatively available information influence specimen PET-CT images.
The measurement of PET-tracer uptake (in MBq/mL) in specimen PET-CT images, comparing patients with various preoperatively available characteristics, as well as intra-operatively available information.
Time frame: Perioperative
To investigate whether preoperatively available information (such as tumor subtype, anatomical location, tumor biology, size, grade or TNM classification) as well as intra-operatively available information influence specimen PET-CT images.
The measurement of electron density (in Hounsfield Units (HU)) in specimen PET-CT images, comparing patients with various preoperatively available characteristics, as well as intra-operatively available information.
Time frame: Perioperative
To investigate the influence of different PET radiotracers, activity, physiological parameters and imaging parameters on PET-radiotracer uptake and image quality in specimen PET-CT images.
The measurement of radiotracer uptake (in MBq/mL) in specimen PET-CT images, comparing the uptake levels and patterns across different PET radiotracers. This will assess whether the type of PET-radiotracer used leads to significant differences in the intensity or distribution of radiotracer uptake in the PET-CT specimen images.
Time frame: Perioperative
To investigate the influence of different PET radiotracers, activity, physiological parameters and imaging parameters on PET-radiotracer uptake and image quality in specimen PET-CT images.
The assessment of PET image quality (e.g. signal to noise ratio) in relation to PET radiotracer activity. This will involve evaluating how changes in radiotracer activity impact image quality and identifying the optimal activity for improving the PET-CT specimen imaging workflow.
Time frame: Perioperative
To investigate the influence of different PET radiotracers, activity, physiological parameters and imaging parameters on PET-radiotracer uptake and image quality in specimen PET-CT images.
The assessment of PET image quality (e.g. signal to noise ratio) in relation to physiological parameters (e.g. uptake time). This will involve evaluating how changes in these parameters impact image quality and identifying the optimal parameters for improving the specimen PET-CT imaging workflow.
Time frame: Perioperative
To investigate the influence of different PET radiotracers, activity, physiological parameters and imaging parameters on PET-radiotracer uptake and image quality in specimen PET-CT images.
The assessment of PET image quality (signal to noise ratio) in relation to imaging parameters (decay time). This will involve evaluating how changes in these parameters impact image quality and identifying the optimal parameters for improving the specimen PET-CT imaging workflow.
Time frame: Perioperative
To assess the safety profile of PET-CT imaging procedures.
The incidence of related (serious and non-serious) adverse events following the specimen PET-CT imaging procedure, including the severity, type, and frequency and relationship (possible, probable, causal relationship).
Time frame: From surgery to 3 years long term follow-up
Plan to share: Undecided
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