Oncologic DisordersNCT06523270
Advanced Imaging Holistic Omics Biobank
An observational study of Oncologic Disorders and Neurologic Disorder, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncologic Disorders, Neurologic Disorder, Pulmonary Disease
- What is being tested?
- Computed Tomography (CT) using Photon Counting CT scanner (Neaotom Alpha, Siemens) and Magnetic Resonance (MRI)
- Type of treatment
- Surgery or procedure
- How many people
- 50,000 participants
- Where
- 1 siteItaly
- Study dates
- 15 Sep 2024to 15 Sep 2034
- 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
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- Absent informed consent signed
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS San Raffaele
Milan, 20132
Antonio Esposito, 02 2643 6102
About this study
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.
Read the 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.
- Being tested
- Computed Tomography (CT) using Photon Counting CT scanner (Neaotom Alpha, Siemens) and Magnetic Resonance (MRI)
- Medical subject headings
- Nervous System Diseases, Lung Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Radiation: Computed Tomography (CT) using Photon Counting CT scanner (Neaotom Alpha, Siemens) and Magnetic Resonance (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Follow-up collection yearly for 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start15 Sep 2024
- Primary completion15 Sep 2034 (estimated)
- Study completion15 Sep 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Oncologic DisordersStudies of the same condition, open and under way.
- 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
- 50,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Esposito, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523270
- Sponsor's protocol ID
- AIMOMICS-BANK
- Status last verified
- Dec 2025
- First submitted
- 18 Jul 2024
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33904776Summers 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.
PubMed 33680078Hagen 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.
PubMed 37793417
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Imaging Holistic Omics Biobank
- ClinicalTrials.gov ID
- NCT06523270
- Acronym / sponsor ID
- AIMOMICS-BANK
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 15 Sep 2034 (estimated)
- Study completion
- 15 Sep 2034 (estimated)
- First posted
- 26 Jul 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| prospective cohort | – | 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Absent informed consent signed
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 |
|---|---|---|
| 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 | Radiation | prospective cohort |
Primary outcome
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
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 15 Jan 2026.
- Background: PubMed 33904776Petralia 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.
- Background: PubMed 33680078Summers 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.
- Background: PubMed 37793417Hagen 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.
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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.
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 Oncologic Disorders and Neurologic Disorder, run by IRCCS San Raffaele 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 1 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: looking for participants now, as of the sponsor's last update on 15 Jan 2026. 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?
Contact Antonio Esposito (0226436102, esposito.antonio@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 NCT06523270, which also lists 3 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 15 Jan 2026.