Prostate CancersPETRiSNCT06970275
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.
An observational study of Prostate Cancers and Breast Cancer, run by XEOS Medical at 5 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancers, Breast Cancer, Head and Neck Cancer
- How many people
- 850 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 19 Nov 2025to 15 Jan 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Under the age of 18 years at the time of resective surgery.
- Women who are pregnant or breastfeeding.
Trial locations and contacts
5 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 4 countries
Belgium2 sites, 2 recruiting
- Not yet recruiting
AZORG
Aalst, 9300
Laurence Tack, Dr., 053 72 87 02, klinischestudies.secretariaat@azorg.be
- Recruiting
AZ Maria Middelares
Ghent
Filip Ameye, Dr., +32 9 246 18 52, klinische.studies@mijnziekenhuis.be
Germany1 site, 1 recruiting
- Recruiting
Universitäts-klinikum Essen
Essen, North Rhine-Westphalia, 45147
David Kersting, Dr., +49 0201 723 0, info@uk-essen.de
Netherlands1 site, 1 recruiting
- Recruiting
UMCG
Groningen
Jasper Vonk, Dr., +31 50 361 6161, j.vonk@umcg.nl
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospitals Coventry and Warwickshire (UHCW) NHS Trust
Coventry, West Midlands, CV2 2DX
Oludolapo Adesanya, Dr., +44 2476 964000, Uhcw.Research3@uhcw.nhs.uk
About this study
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.
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.
- Conditions
- Prostate Cancers, Breast Cancer, Head and Neck Cancer, Cancer
- Keywords
- PET-CT, Registry, Imaging, cancer
- Medical subject headings
- Prostatic Neoplasms, Breast Neoplasms, Head and Neck Neoplasms, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Perioperative
Secondary outcomes (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.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: From surgery to 3 years long term follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start19 Nov 2025
- Primary completion15 Jan 2031 (estimated)
- Study completion15 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- XEOS Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970275
- Sponsor's protocol ID
- PETRiS
- Acronym
- PETRiS
- Status last verified
- Sep 2026
- First submitted
- 25 Apr 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06970275
- Acronym / sponsor ID
- PETRiS / PETRiS
- Conditions
- Prostate Cancers, Breast Cancer, Head and Neck Cancer, Cancer
- Keywords
- PET-CT, Registry, Imaging, cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- XEOS MedicalIndustry (pharma, biotech, devices)
- Study start
- 19 Nov 2025 (actual)
- Primary completion
- 15 Jan 2031 (estimated)
- Study completion
- 15 Jan 2031 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Under the age of 18 years at the time of resective surgery.
- Women who are pregnant or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancers and Breast Cancer, run by XEOS Medical at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium, Germany, Netherlands, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the correlation between the specimen PET-CT images and final histopathological examination of the specimen. (time frame: Perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.