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NCT Number: NCT06970275

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 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.

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Key information

Conditions

Prostate Cancers Breast Cancer Breast Diseases Breast Neoplasms Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Head and Neck Cancer Head and Neck Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AZ Maria Middelares, Ghent, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. To assess the correlation between the specimen PET-CT images and final histopathological examination of the specimen.

    Time frame: Perioperative

    The concordance rate between the specimen PET-CT images and final histopathological examination of the specimen.

Secondary outcomes

  1. 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.

    Time frame: Perioperative

    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).

  2. To assess the correlation between long-term follow-up clinical outcome and specimen PET-CT imaging findings.

    Time frame: From surgery to 3 years long term follow-up

    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.

  3. To evaluate the influence of neoadjuvant treatment (NAT) on PET radiotracer uptake in specimen PET-CT imaging.

    Time frame: Perioperative

    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.

  4. 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.

    Time frame: Perioperative

    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.

  5. 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.

    Time frame: Perioperative

    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.

  6. 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.

    Time frame: Perioperative

    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.

  7. 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.

    Time frame: Perioperative

    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.

  8. 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.

    Time frame: Perioperative

    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.

  9. 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.

    Time frame: Perioperative

    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.

  10. To assess the safety profile of PET-CT imaging procedures.

    Time frame: From surgery to 3 years long term follow-up

    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).

Sponsors and collaborators

Lead sponsor

XEOS Medical

Industry

Registry information

Official study title

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.

Acronym: PETRiS

Important dates

Study start
2025
Primary completion
2031
Study completion
2031
First posted
May 14, 2025
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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