Advanced Imaging Holistic Omics Biobank

NCT06523270 | Recruiting

• 1 other identifier: AIMOMICS-BANK
• Study Type: observational
• Target: 50,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oncologic Disorders; Neurologic Disorder; Pulmonary Disease; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• 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

  Follow-up collection yearly for 10 years

Study Arms (1)

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)

Interventions

Computed Tomography (CT) using Photon Counting CT scanner (Neaotom Alpha, Siemens) and Magnetic Resonance (MRI) RADIATION

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

prospective cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Absent informed consent signed

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS San Raffaele

Milan, 20132, Italy

RECRUITING

Related Publications (3)

• Petralia G, Koh DM, Attariwala R, Busch JJ, Eeles R, Karow D, Lo GG, Messiou C, Sala E, Vargas HA, Zugni F, Padhani AR. Oncologically Relevant Findings Reporting and Data System (ONCO-RADS): Guidelines for the Acquisition, Interpretation, and Reporting of Whole-Body MRI for Cancer Screening. Radiology. 2021 Jun;299(3):494-507. doi: 10.1148/radiol.2021201740. Epub 2021 Apr 27.

  PMID: 33904776 BACKGROUND

• Summers P, Saia G, Colombo A, Pricolo P, Zugni F, Alessi S, Marvaso G, Jereczek-Fossa BA, Bellomi M, Petralia G. Whole-body magnetic resonance imaging: technique, guidelines and key applications. Ecancermedicalscience. 2021 Jan 7;15:1164. doi: 10.3332/ecancer.2021.1164. eCollection 2021.

  PMID: 33680078 BACKGROUND

• Hagen F, Soschynski M, Weis M, Hagar MT, Krumm P, Ayx I, Taron J, Krauss T, Hein M, Ruile P, von Zur Muehlen C, Schlett CL, Neubauer J, Tsiflikas I, Russe MF, Arnold P, Faby S, Froelich MF, Weiss J, Stein T, Overhoff D, Bongers M, Nikolaou K, Schonberg SO, Bamberg F, Horger M. Photon-counting computed tomography - clinical application in oncological, cardiovascular, and pediatric radiology. Rofo. 2024 Jan;196(1):25-35. doi: 10.1055/a-2119-5802. Epub 2023 Oct 4. English, German.

  PMID: 37793417 BACKGROUND

MeSH Terms

Conditions

Nervous System Diseases; Lung Diseases; Cardiovascular Diseases

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Central Study Contacts

Antonio Esposito

CONTACT

0226436102; esposito.antonio@hsr.it

Anna Palmisano Palmisano

CONTACT

0226436106; palmisano.anna@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 26, 2024
• Study Start: September 15, 2024
• Primary Completion (Estimated): September 15, 2034
• Study Completion (Estimated): September 15, 2034
• Last Updated: January 15, 2026

Record last verified: 2025-12

Locations

IT (1)