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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Prostate Cancers, Breast Cancer, Head and Neck Cancer, Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium, Germany, Netherlands, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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.
Overview
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.
Primary outcome measures
- To assess the correlation between the specimen PET-CT images and final histopathological examination of the specimen. [Time frame: Perioperative]
Secondary outcome measures (10)
- 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]
- 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]
- To evaluate the influence of neoadjuvant treatment (NAT) on PET radiotracer uptake in specimen PET-CT imaging. [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. [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. [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. [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. [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. [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. [Time frame: Perioperative]
- To assess the safety profile of PET-CT imaging procedures. [Time frame: From surgery to 3 years long term follow-up]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Belgium · 1 center
- AZ Maria Middelares — Ghent
Germany · 1 center
- Universitäts-klinikum Essen — Essen
Netherlands · 1 center
- UMCG — Groningen
United Kingdom · 1 center
- University Hospitals Coventry and Warwickshire (UHCW) NHS Trust — Coventry
Identifiers
NCT: NCT06970275 · PETRiS