Kidney DiseasesMEDICALBUMNCT06354829
Medical Images Collection Research
An observational study of Kidney Diseases and Brain Diseases, run by Mario Negri Institute for Pharmacological Research at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Diseases, Brain Diseases
- What is being tested?
- Medical imaging procedures
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jan 2025to Sep 2049
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
Italy1 site
Clinical Research Center for Rare Disease Aldo e Cele Daccò
Ranica, BG, 24020
About this study
Official title: Creation of a Collection of Medical Images to Facilitate Their Use for Future Not-for-profit Research
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.
Read the 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.
- Conditions
- Kidney Diseases, Brain Diseases
- Being tested
- Medical imaging procedures
- Keywords
- Medical images, Repository, Kidney diseases, Cerebral diseases, Database
- Medical subject headings
- Kidney Diseases, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical imaging proceduresDiagnostic test
The following medical imaging procedure will b applied: Magnetic resonance images (MRI), computerized tomography images (CT), and ultrasound images (US).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Diagnostic Test: Medical imaging procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creation of a medical images collection
Collection of medical images and related data of participants to concluded or ongoing clinical trials.
Measured: Image acquisitions at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start7 Jan 2025
- Primary completionSep 2049 (estimated)
- Study completionSep 2049 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Papa Giovanni XXIII Hospital
- Responsible party
- Sponsor
- Investigators
- Matias Trillini, PhD, Study director, Istituto Di Ricerche Farmacologiche Mario Negri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354829
- Sponsor's protocol ID
- MEDICALBUM
- Acronym
- MEDICALBUM
- Status last verified
- Aug 2025
- First submitted
- 15 Mar 2024
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21683674Caroli 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.
PubMed 36731251Soliveri 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.
PubMed 37753863Villa 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.
PubMed 37926085
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation of a Collection of Medical Images to Facilitate Their Use for Future Not-for-profit Research
- ClinicalTrials.gov ID
- NCT06354829
- Acronym / sponsor ID
- MEDICALBUM / MEDICALBUM
- Conditions
- Kidney Diseases, Brain Diseases
- Keywords
- Medical images, Repository, Kidney diseases, Cerebral diseases, Database
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Collaborators
- Papa Giovanni XXIII Hospital
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- Sep 2049 (estimated)
- Study completion
- Sep 2049 (estimated)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kidney cohort | – | Diagnostic Test: Medical imaging proceduresOnce 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 | – | Diagnostic Test: Medical imaging proceduresOnce 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical imaging proceduresThe following medical imaging procedure will b applied: Magnetic resonance images (MRI), computerized tomography images (CT), and ultrasound images (US). | Diagnostic test | Cerebral cohort, Kidney cohort |
Primary outcome
Creation of a medical images collection
Time frame: Image acquisitions at baseline
Collection of medical images and related data of participants to concluded or ongoing clinical trials.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Background: PubMed 21683674Caroli 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.
- Background: PubMed 36731251Caroli 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.
- Background: PubMed 37753863Soliveri 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.
- Background: PubMed 37926085Villa 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matias Trillini, PhD study director
Istituto Di Ricerche Farmacologiche Mario Negri
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Diseases and Brain Diseases, run by Mario Negri Institute for Pharmacological Research at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Creation of a medical images collection (time frame: Image acquisitions at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06354829, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.