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.

NCT06970275 | Recruiting

• 1 other identifier: PETRiS
• Study Type: observational
• Target: 850
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancers; Breast Cancer; Head and Neck Cancer; Cancer

Keywords

PET-CT; Registry; Imaging; cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Perioperative

• 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

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

  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.

  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.

  Perioperative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Under the age of 18 years at the time of resective surgery.
• Women who are pregnant or breastfeeding.

Sponsors & Collaborators

• XEOS Medical: lead

Study Sites (1)

AZ Maria Middelares

Ghent, Belgium

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Breast Neoplasms; Head and Neck Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 14, 2025
• Study Start: November 19, 2025
• Primary Completion (Estimated): January 15, 2031
• Study Completion (Estimated): January 15, 2031
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

BE (1)