Adrenal CancerNCT06801340
Assessment of Metabolic Complications in Patients With Adrenal Tumors Through Radiological Images
An observational study of Adrenal Cancer, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adrenal Cancer
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2025to 31 Dec 2025
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in the study will be enrolled at participating centers, selected from those who meet the inclusion/exclusion criteria.
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
Guido Di Dalmazi, MD, +390512143009, guido.didalmazi@unibo.it
Guido Di Dalmazi, MD
About this study
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.
Read the 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
- Conditions
- Adrenal Cancer
- Medical subject headings
- Adrenal Gland Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start1 Jan 2025
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenal CancerStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guido Di Dalmazi, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801340
- Sponsor's protocol ID
- RADIO-AT
- Status last verified
- Dec 2024
- First submitted
- 30 Dec 2024
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Metabolic Complications in Patients With Adrenal Tumors Through Radiological Images
- ClinicalTrials.gov ID
- NCT06801340
- Acronym / sponsor ID
- RADIO-AT
- Conditions
- Adrenal Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in the study will be enrolled at participating centers, selected from those who meet the inclusion/exclusion criteria.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic Accuracy of Radiomics-Derived Parameters for Differentiating Benign and Malignant Adrenal Masses
Time frame: through study completion, an average of 1 year
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.
3 secondary outcomes
Association of Radiomics-Derived Parameters with Ki67 Values
Time frame: through study completion, an average of 1 years
Association of Radiomics-Derived Parameters with Weiss' Anatomopathologic Score
Time frame: through study completion, an average of 1 year
Association of Radiomics-Derived Parameters with Occurrence of Distant Metastasis
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Adrenal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruitingPhase 2
Pembrolizumab in the Treatment of Advanced, Progressive Adrenocortical Carcinoma.
Adrenocortical Carcinoma
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 2
Testing the Addition of an Anti-Cancer Drug, Cabozantinib to the Immunotherapy Drug Cemiplimab (REGN2810), in Adolescents and Adults With Advanced Adrenocortical Cancer
Locally Advanced Adrenal Cortical Carcinoma, Metastatic Adrenal Cortical Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guido Di Dalmazi, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adrenal Cancer, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guido Di Dalmazi, MD (+390512143009, guido.didalmazi@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of Radiomics-Derived Parameters for Differentiating Benign and Malignant Adrenal Masses (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.