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.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorXEOS Medical

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Under the age of 18 years at the time of resective surgery.

Women who are pregnant or breastfeeding.

Trial 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.

Trial design

Design model

Case-only

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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.

Time frame
Perioperative

Secondary outcomes

1

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).

Time frame
Perioperative
2

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.

Time frame
From surgery to 3 years long term follow-up
3

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.

Time frame
Perioperative
4

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.

Time frame
Perioperative

Other outcomes

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