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

NCT06801340 | Recruiting

• 1 other identifier: RADIO-AT
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adrenal Cancer

Outcome Measures

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.

  through study completion, an average of 1 year

Secondary Outcomes (3)

• Association of Radiomics-Derived Parameters with Ki67 Values

  through study completion, an average of 1 years

• Association of Radiomics-Derived Parameters with Weiss' Anatomopathologic Score

  through study completion, an average of 1 year

• Association of Radiomics-Derived Parameters with Occurrence of Distant Metastasis

  through study completion, an average of 1 year

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

You may qualify if:

• 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

You may not qualify if:

• none

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Adrenal Gland Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Guido Di Dalmazi, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guido Di Dalmazi, MD

CONTACT

+390512143009; guido.didalmazi@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 30, 2025
• Study Start: January 1, 2025
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 30, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)