NCT06354829

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
284mo left

Started Jan 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Jan 2025Sep 2049

First Submitted

Initial submission to the registry

March 15, 2024

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 9, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

January 7, 2025

Completed
24.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2049

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2049

Last Updated

September 4, 2025

Status Verified

August 1, 2025

Enrollment Period

24.7 years

First QC Date

March 15, 2024

Last Update Submit

August 27, 2025

Conditions

Kidney DiseasesBrain Diseases

Keywords

Medical imagesRepositoryKidney diseasesCerebral diseasesDatabase

Outcome Measures

Primary Outcomes (1)

  • Creation of a medical images collection

    Collection of medical images and related data of participants to concluded or ongoing clinical trials.

    Image acquisitions at baseline

Study Arms (2)

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).

Diagnostic Test: Medical imaging procedures

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.

Diagnostic Test: Medical imaging procedures

Interventions

Medical imaging proceduresDIAGNOSTIC_TEST

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

Cerebral cohortKidney cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Center for Rare Disease Aldo e Cele Daccò

Ranica, BG, 24020, Italy

Location

Related Publications (4)

  • 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.

    PMID: 21683674BACKGROUND

  • 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.

    PMID: 36731251BACKGROUND

  • 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.

    PMID: 37753863BACKGROUND

  • 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.

    PMID: 37926085BACKGROUND

MeSH Terms

Conditions

Kidney DiseasesBrain Diseases

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Matias Trillini, PhD

    Istituto Di Ricerche Farmacologiche Mario Negri

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2024

First Posted

April 9, 2024

Study Start

January 7, 2025

Primary Completion (Estimated)

September 1, 2049

Study Completion (Estimated)

September 1, 2049

Last Updated

September 4, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)