Advanced Imaging Holistic Omics Biobank

January 14, 2026 updated by: Antonio Esposito, IRCCS San Raffaele
Imaging methods today represent the pillar of prevention, diagnosis, patients monitoring and treatment. Improvement in technology led the development of increasingly high-performance scanners whose potential has not yet been fully explored. In particular, recently introduced photon counting CT scanner and new high filed MRI offers a lake of latent information derived from the images (e.g. spectral data from CT) of potentially great interest and potentially able to provide new insight but that are currently mostly unexplored .These features are also called "opportunist features" because they are in each exam and can be freely derived from images without changing the study protocol used for clinical practice examination but extracted a posteriori from the images representing a precious source of deep characterization of the patients, equally or even more than a genomic analysis, with possible high relevance in the field of screening and prevention, being able to contribute to defining signatures indicating a particular risk of remotely developing a specific pathological condition. The prospective collection of clinical and imaging data from subjects undergoing diagnostic tests with advanced technology has the potential to increase knowledge of the pathophysiological mechanisms of different pathological conditions, to explore and validate the diagnostic-predictive value of opportunistic features not currently used in practice clinical, to increase the diagnostic and prognostic accuracy of CT and MRI examinations and to provide a unique pool for scientific research. Previous relevant experience was conducted in the United Kingdom (UK biobank) where data from over 500,000 patients have been collected in the last 10 years, providing an enormous pool for spontaneous and funded scientific research. This project (UK biobank), although of enormous scientific value, is currently obsolete in terms of the imaging technology used.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The present study is a observational prospective single center study aimed to build a large-scale multiomic database of patients submitted to advanced imaging study performed Photon Counting TC (Neaotom Alpha, Siemens) and 3T Magnetic Resonance Imaging (MR 7700, Philips).

Consecutive adult patients submitted to the aforementioned imaging modality will be enrolled.

For the enrolled patients imaging raw data will be stored additionally to conventional images, routinely stored for legal requirements.

At the time of enrollment clinical, demographic and lab test will be collected as well as results from genetic test if available, and related previous imaging study (e.g. mammography in patients submitted to whole body MRI or breast MRI, colonscopy in patients submitted to abdominal CT or MRI).

For patients candidate to imaging examination using contrast media at the time of needle position for contrast administration a blood sample will be collected for lab test analysis.

In case of imaging, clinical and laboratory examination performed at OSR, these data will be automatically collected.

Annual update is required by the study with the questionnaires and interviews performed with in site clinical visit, telehealth or whenever no one of the previous method is feasible with telephonic call.

During the annual follow-up, clinical, lab test and imaging data will be collected.

If patients perform annual check-up at OSR, it will ask to automatically update patients' record with those information and results.

Data collected and updated will be chosen according to the patients specific risk profile and the clinical indication to perform III level imaging.

Study Type

Observational

Enrollment (Estimated)

50000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Milan, Italy, 20132
        • Recruiting
        • IRCCS San Raffaele
        • Contact:
          • Antonio Esposito
          • Phone Number: 02 2643 6102

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

All adult (≥18 y.o) subjects (until 50000 individuals) presenting to the U.O of Radiologia DiMer "Advanced Imaging for Personalized Medicine" to be submitted to imaging study on advanced scanner

Description

Inclusion Criteria:

  • Adult subjects (>18 y.o.) submitted to Computed Tomography (CT) using Photon Counting CT scanner (Neaotom Alpha, Siemens) and Magnetic Resonance (MRI) exams acquired with 3T scanner (MR 7700, Philips) for examination required for clinical practice or for clinical trials at the IRCCS San Raffaele Hospital who signe an Informed Consent authorizing data collection.

Exclusion Criteria:

  • Absent informed consent signed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
prospective cohort
All adult (≥18 y.o) subjects (until 50000 individuals) presenting to the U.O of Radiologia DiMer "Advanced Imaging for Personalized Medicine" to be submitted to imaging study on advanced scanner
Radiation: Computed Tomography (CT) using Photon Counting CT scanner (Neaotom Alpha, Siemens) and Magnetic Resonance (MRI)
All adult (≥18 y.o) subjects (until 50000 individuals) presenting to the U.O of Radiologia DiMer "Advanced Imaging for Personalized Medicine" to be submitted to imaging study on advanced scanner

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
a large scale multiomics archive of patients submitted to advanced imaging studies to support a wide range of research intended to identify imaging signature able to improve the prevention, diagnosis and treatment of disease
Time Frame: Follow-up collection yearly for 10 years
Follow-up collection yearly for 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2024

Primary Completion (Estimated)

September 15, 2034

Study Completion (Estimated)

September 15, 2034

Study Registration Dates

First Submitted

July 18, 2024

First Submitted That Met QC Criteria

July 25, 2024

First Posted (Actual)

July 26, 2024

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIMOMICS-BANK

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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