Medical Images Collection Research

Kidney Diseases Clinical Trial

— MEDICALBUM  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06354829
• Other study ID #: MEDICALBUM
• Status: Not yet recruiting
• Start date: April 2024
• Est. completion date: April 2049

Study information

• Verified date: March 2024
• Source: Mario Negri Institute for Pharmacological Research
• Contact: Anna Caroli, PhD
• Phone: +39 035 4535381
• Email: anna.caroli[@]marionegri.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: April 2049
• Est. primary completion date: April 2049
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Kidney Diseases

Intervention

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

Locations

Country	Name	City	State
Italy	Clinical Research Center for Rare Disease Aldo e Cele Daccò	Ranica	BG

Sponsors (2)

Lead Sponsor	Collaborator
Mario Negri Institute for Pharmacological Research	Papa Giovanni XXIII Hospital

Country where clinical trial is conducted

Italy, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. 2023 Nov 3. doi: 10.1159/000534893. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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