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.

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.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06970275

Acronym

PETRiS

Enrollment

850

Registered

2025-05-14

Start date

2025-11-19

Completion date

2031-01-15

Last updated

2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Cancer, Head and Neck Cancer, Prostate Cancers

Keywords

PET-CT, Registry, Imaging, cancer

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
To assess the correlation between the specimen PET-CT images and final histopathological examination of the specimen.	Perioperative	The concordance rate between the specimen PET-CT images and final histopathological examination of the specimen.

Secondary

Measure	Time frame	Description
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.	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).
To assess the correlation between long-term follow-up clinical outcome and specimen PET-CT imaging findings.	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.
To evaluate the influence of neoadjuvant treatment (NAT) on PET radiotracer uptake in specimen PET-CT imaging.	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.
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.	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.
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.	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.
To assess the safety profile of PET-CT imaging procedures.	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).

Countries

Belgium, Germany, Netherlands, United Kingdom

Outcome results