Medical Images Collection Research (MEDICALBUM)

Creation of a Collection of Medical Images to Facilitate Their Use for Future Not-for-profit Research

This is a not-for-profit project for the collection, archiving and reuse of magnetic resonance imaging, computed tomography and ultrasound images, and related demographic and clinical data, for research purposes only.

Study Overview

Status

Active, not recruiting

Detailed Description

The collection of medical images and related data will be proposed to each participant to concluded or ongoing clinical trials promoted or partnered by the Mario Negri Institute for Pharmacological Research (IRFMN) requiring the collection of images or subject who perform a clinical practice examination at the Hospitals that adopted the image acquisition protocols of IRFMN. Each subject will be provided with an informed sheet and will be asked to provide consent to donate his/her medical images and related data for future research. For participants in new clinical trials, the consent sheet of the study will be accompanied by this trial's consent sheet.

In addition to the information reported in the specific trial information sheet, each subject shall have access to the list of studies included in the Clinical Trials Register of IRFMN/Bioengineering Department that are reusing their medical image data.

Any new study protocol promoted by IRFMN and which provides for the use of medical images stored in this trial will be submitted to the local Ethics Committee for approval.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • BG
      • Ranica, BG, Italy, 24020
        • Clinical Research Center for Rare Disease Aldo e Cele Daccò

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants to concluded or ongoing clinical trials promoted or partnered by IRFMN requiring the collection of images or subjects who perform a clinical practice examination at the Hospitals that adopted the image acquisition protocols of IRFMN.

Description

Inclusion Criteria:

  • Healthy subjects: Adults ≥ 18 years; Subjects with no previous history of kidney or cerebral disease
  • Patients: Adults ≥ 18 years; Subjects with renal or cerebral disease

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Kidney cohort
Once assigned to the renal cohort, the relevant set of images will then be further assigned to a specific subpopulation depending on the pathology. In parallel, the associated anamnestic, demographic, and clinical data, will be included in a purpose-designed electronic Case Report Form (eCRF).
The following medical imaging procedure will b applied: Magnetic resonance images (MRI), computerized tomography images (CT), and ultrasound images (US).
Cerebral cohort
Once assigned to the cerebral cohort, the relevant set of images will then be further assigned to a specific subpopulation depending on the pathology. In parallel, the associated anamnestic, demographic, and clinical data, will be included in a purpose-designed eCRF.
The following medical imaging procedure will b applied: Magnetic resonance images (MRI), computerized tomography images (CT), and ultrasound images (US).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Creation of a medical images collection
Time Frame: Image acquisitions at baseline
Collection of medical images and related data of participants to concluded or ongoing clinical trials.
Image acquisitions at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Matias Trillini, PhD, Istituto Di Ricerche Farmacologiche Mario Negri

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2025

Primary Completion (Estimated)

September 1, 2049

Study Completion (Estimated)

September 1, 2049

Study Registration Dates

First Submitted

March 15, 2024

First Submitted That Met QC Criteria

April 4, 2024

First Posted (Actual)

April 9, 2024

Study Record Updates

Last Update Posted (Estimated)

September 4, 2025

Last Update Submitted That Met QC Criteria

August 27, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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