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.

NCT ID: NCT06970275

Last Updated: 2025-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

850 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-19

Study Completion Date

2031-01-15

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancers Breast Cancer Head and Neck Cancer Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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XEOS Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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AZ Maria Middelares

Ghent, , Belgium

Site Status RECRUITING

Countries

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Belgium

Facility Contacts

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Dr. Ameye

Role: primary

+32 9 246 18 52

Other Identifiers

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PETRiS

Identifier Type: -

Identifier Source: org_study_id

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