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

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.

Study Overview

• Status: Recruiting
• Conditions: Adrenal Cancer

Detailed Description

Retrospective study based on data already available at each Center. Participating Centers will identify patients based on shared inclusion/exclusion criteria. Pseudonymized CT images of each patient in DICOM format will be sent from each center to the Coordinating Center to perform radiomics analysis. Images will be transferred via File Transfer Protocol while respecting the anonymity of enrolled patients. Images will be deposited in a dedicated study folder created by the AOUBO ICT Service. Images will be accessible only to the Investigator and Principal Investigator and/or their delegates via personalized credentials, which can be accessed only from IRCCS AOUBO computers and facilities. The folder to which the images will be transferred will be accessible only to the Principal Investigator and his/her Collaborators through customized private credentials usable only through IRCCS AOUBO networks, computers and facilities. Radiomics, which will be applied to existing CT images, will in no way affect the care pathway of patients

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Guido Di Dalmazi, MD; Phone Number: +390512143009; Email: guido.didalmazi@unibo.it

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • IRCCS Azienda Ospedaliero-Universitaria di Bologna
    • Contact: Guido Di Dalmazi, MD; Phone Number: +390512143009; Email: guido.didalmazi@unibo.it
    • Principal Investigator: Guido Di Dalmazi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	through study completion, an average of 1 years
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.	through study completion, an average of 1 year
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.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Guido Di Dalmazi, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 30, 2024
• First Submitted That Met QC Criteria: January 24, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 24, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Adrenal Gland Diseases; Adrenal Gland Neoplasms
• Other Study ID Numbers: RADIO-AT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No