Medical Images Collection Research

Recruiting

• Conditions: Brain Diseases; Kidney Diseases
• Interventions: Diagnostic Test: Medical imaging procedures

• Registration Number: NCT06354829
• Lead Sponsor: Mario Negri Institute for Pharmacological Research

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-03-15
• Study First Submitted QC: 2024-04-04
• Study First Posted: 2024-04-09
• Status Verified: 2025-01
• Study Start: 2025-01-07
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-24
• Primary Completion: 2049-09
• Study Completion: 2049-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Kidney cohort	Medical imaging procedures	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).
Cerebral cohort	Medical imaging procedures	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.

Primary Outcome Measures

Name	Time	Method
Creation of a medical images collection	Image acquisitions at baseline	Collection of medical images and related data of participants to concluded or ongoing clinical trials.

Trial Locations

Locations (1)

Clinical Research Center for Rare Disease Aldo e Cele Daccò; 🇮🇹 Ranica, BG, Italy