Assessment of Metabolic Complications in Patients With Adrenal Tumors Through Radiological Images

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

Retrospective study based on data already available at each Center. Pseudonymized CT images of each patient in DICOM format will be sent from each center to the Coordinating Center to perform radiomics analysis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Patients with adrenal tumor who underwent adrenectomy surgery from 1-1-2000 to 30-5-2023, performed according to clinical necessity and indications of international guidelines,with availability of histologic diagnosis or adrenal tumor that did not undergo adrenectomy surgery with diagnosis of benignity confirmed by radiologic stability at 6-12 months after first finding(as indicated in guidelines)

Availability of radiological images in DICOM format of abdominal CT scan in which the adrenal tumor is first described, obtained on the date of first evaluation at the participating center (necessarily before surgery for patients undergoing adrenectomy)

Signature of informed consent

Disqualifiers

none

Trial population

Patients in the study will be enrolled at participating centers, selected from those who meet the inclusion/exclusion criteria.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Diagnostic Accuracy of Radiomics-Derived Parameters for Differentiating Benign and Malignant Adrenal Masses

This measure will assess the diagnostic ability of specific radiomics-derived parameters, including texture analysis and intensity features, in identifying the nature (benign or malignant) of adrenal masses. The diagnostic performance will be evaluated through sensitivity, specificity.

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

Association of Radiomics-Derived Parameters with Ki67 Values

This measure evaluates the correlation between radiomics-derived imaging parameters and Ki67 proliferation index values. Ki67 values will be assessed as a percentage using immunohistochemical staining, and the correlation will be expressed as a Pearson or Spearman correlation coefficient, depending on data distribution.

Time frame
through study completion, an average of 1 years
2

Association of Radiomics-Derived Parameters with Weiss' Anatomopathologic Score

This measure evaluates the correlation between radiomics-derived imaging parameters and the Weiss anatomopathologic score. The Weiss score will be determined based on pathological examination, and the association will be reported as a correlation coefficient.

Time frame
through study completion, an average of 1 year
3

Association of Radiomics-Derived Parameters with Occurrence of Distant Metastasis

This measure evaluates the relationship between radiomics-derived imaging parameters and the occurrence of distant metastases in patients with adrenal tumors. The occurrence of metastases will be reported as a binary outcome (presence or absence), and the association will be analyzed using logistic regression models or similar statistical methods.

Time frame
through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.