Medical Images Collection Research

NCT ID: NCT06354829

Last Updated: 2025-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-07

Study Completion Date

2049-09-30

Brief Summary

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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

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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.

Conditions

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Kidney Diseases Brain Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

Medical imaging procedures

Intervention Type DIAGNOSTIC_TEST

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.

Medical imaging procedures

Intervention Type DIAGNOSTIC_TEST

The following medical imaging procedure will b applied: Magnetic resonance images (MRI), computerized tomography images (CT), and ultrasound images (US).

Interventions

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Medical imaging procedures

The following medical imaging procedure will b applied: Magnetic resonance images (MRI), computerized tomography images (CT), and ultrasound images (US).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Papa Giovanni XXIII Hospital

OTHER

Sponsor Role collaborator

Mario Negri Institute for Pharmacological Research

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matias Trillini, PhD

Role: STUDY_DIRECTOR

Istituto Di Ricerche Farmacologiche Mario Negri

Locations

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Clinical Research Center for Rare Disease Aldo e Cele Daccò

Ranica, BG, Italy

Site Status

Countries

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Italy

References

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Caroli A, Antiga L, Conti S, Sonzogni A, Fasolini G, Ondei P, Perico N, Remuzzi G, Remuzzi A. Intermediate volume on computed tomography imaging defines a fibrotic compartment that predicts glomerular filtration rate decline in autosomal dominant polycystic kidney disease patients. Am J Pathol. 2011 Aug;179(2):619-27. doi: 10.1016/j.ajpath.2011.04.036. Epub 2011 Jun 17.

Reference Type BACKGROUND
PMID: 21683674 (View on PubMed)

Caroli A, Capelli S, Napolitano A, Cabrini G, Arrigoni A, Pezzetti G, Previtali M, Longhi LG, Zangari R, Lorini FL, Sessa M, Remuzzi A, Gerevini S. Brain diffusion alterations in patients with COVID-19 pathology and neurological manifestations. Neuroimage Clin. 2023;37:103338. doi: 10.1016/j.nicl.2023.103338. Epub 2023 Jan 28.

Reference Type BACKGROUND
PMID: 36731251 (View on PubMed)

Soliveri L, Bozzetto M, Brambilla P, Caroli A, Remuzzi A. Hemodynamics in AVF over time: A protective role of vascular remodeling toward flow stabilization. Int J Artif Organs. 2023 Oct-Nov;46(10-11):547-554. doi: 10.1177/03913988231191960. Epub 2023 Sep 27.

Reference Type BACKGROUND
PMID: 37753863 (View on PubMed)

Villa G, Daina E, Brambilla P, Gamba S, Leone VF, Carrara C, Rizzo P, Noris M, Remuzzi G, Remuzzi A, Caroli A. Functional Magnetic Resonance Imaging to Monitor Disease Progression: A Prospective Study in Patients with Primary Membranoproliferative Glomerulonephritis. Nephron. 2024;148(6):367-378. doi: 10.1159/000534893. Epub 2023 Nov 3.

Reference Type BACKGROUND
PMID: 37926085 (View on PubMed)

Other Identifiers

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MEDICALBUM

Identifier Type: -

Identifier Source: org_study_id

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