Clinical trial NCT06354829: Medical Images Collection Research
Official title: Creation of a Collection of Medical Images to Facilitate Their Use for Future Not-for-profit Research
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Diseases
Brain Diseases
Keywords: Medical images
Repository
Kidney diseases
Cerebral diseases
Database
Lead sponsor: Mario Negri Institute for Pharmacological Research
Sponsor class: OTHER
Collaborators: name: Papa Giovanni XXIII Hospital
First posted: 2024-04-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Creation of a medical images collection
timeFrame: Image acquisitions at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Ranica
country: Italy
facility: Clinical Research Center for Rare Disease Aldo e Cele Daccò
state: BG
Study officials:
affiliation: Istituto Di Ricerche Farmacologiche Mario Negri
name: Matias Trillini, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
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.
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.
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. 2024;148(6):367-378. doi: 10.1159/000534893. Epub 2023 Nov 3.