Whole Body ImagingAITECH-MRINCT07678320
AI Technologies for Enhanced and Celerated High-Field WB-MRI
An observational study of Whole Body Imaging and Prostate, run by IRCCS San Raffaele.
Trial summary
Single-center, cross-sectional observational study assessing the feasibility of advanced accelerated MRI sequences versus standard ones in terms of image quality, diagnostic reliability, and acquisition time. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Whole Body Imaging, Prostate, MRI
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 May 2029
- 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: Consecutive adults (≥18 years) admitted to the Advanced Imaging for Personalized Medicine Unit for screening WB-MRI, including a male subgroup undergoing prostate-focused imaging to rule out malignancy. Subjects refusing consent, with claustrophobia, or with metallic implants compromising image quality are excluded.
Who may be able to join
- Consecutive adults (≥18 y.o.) admitted to the UO for W MRI for screening procedure.
- Consecutive adult male patients (≥18 y.o.) admitted to the UO for WB-MRI for screening procedure and focus on prostate.
Who cannot join
- refused to consent
- claustrophobia
- metal prosthesis potentially affecting image quality
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Single-center, cross-sectional observational study assessing the feasibility of advanced accelerated MRI sequences versus standard ones in terms of image quality, diagnostic reliability, and acquisition time.
- Conditions
- Whole Body Imaging, Prostate, MRI, Lung, Vascular
- Keywords
- MRI, Whole Body, Accelerated Imaging, Prostate Imaging, Vascular
What is being measured
The primary outcome is the main question the study is designed to answer.
Image quality
Comparison between standard and accelerated MRI sequences in terms of diagnostic accuracy, acquisition time.
Measured: 30 months
Secondary outcomes (1)
Image quality - subjective
Likert-scale evaluation of images between independent readers with different levvels of experience
Measured: 30-36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2028 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Whole Body ImagingStudies 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
- Cross-sectional
- Enrolment
- 600 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
- NCT07678320
- Sponsor's protocol ID
- AITECH-MRI
- Acronym
- AITECH-MRI
- Status last verified
- Sep 2026
- First submitted
- 25 Jun 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kim BK, Kim JS, Lee HJ, Lee JK, Lee HA, Pak S. Low- Versus High-Concentration Iodine Contrast for Hepatic Multiphase CT in Chronic Liver Disease: Image Quality, Lesion Detectability, and Iodine Load Reduction with Modern MDCT-A Retrospective Non-Inferiority Study. Diagnostics (Basel). 2025 Nov 27;15(23):3026. doi: 10.3390/diagnostics15233026.
PubMed 41374407Breit HC, Vosshenrich J, Hofmann V, Rusche T, Kovacs BK, Bach M, Manneck S, Harder D. Image Quality of Lumbar Spine Imaging at 0.55T Low-Field MRI is Comparable to Conventional 1.5T MRI - Initial Observations in Healthy Volunteers. Acad Radiol. 2023 Nov;30(11):2440-2446. doi: 10.1016/j.acra.2023.01.037. Epub 2023 Feb 24.
PubMed 36841743Haller S, Hedderich D, Federau C, Weisstanner C, Edjlali M, Cauter SV, Zaharchuk G. The Current Status of AI-accelerated MRI Techniques in Clinical Use. Radiology. 2025 Nov;317(2):e243819. doi: 10.1148/radiol.243819.
PubMed 41186470Li C, Lei S, Ding L, Xu Y, Wu X, Wang H, Zhang Z, Gao T, Zhang Y, Li L. Global burden and trends of lung cancer incidence and mortality. Chin Med J (Engl). 2023 Jul 5;136(13):1583-1590. doi: 10.1097/CM9.0000000000002529.
PubMed 37027426Rata M, Blackledge M, Scurr E, Winfield J, Koh DM, Dragan A, Candito A, King A, Rennie W, Gaba S, Suresh P, Malcolm P, Davis A, Nilak A, Shah A, Gandhi S, Albrizio M, Drury A, Roberts S, Jenner M, Brown S, Kaiser M, Messiou C. Implementation of Whole-Body MRI (MY-RADS) within the OPTIMUM/MUKnine multi-centre clinical trial for patients with myeloma. Insights Imaging. 2022 Jul 28;13(1):123. doi: 10.1186/s13244-022-01253-0.
PubMed 35900614Petralia 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 33904776
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI Technologies for Enhanced and Celerated High-Field WB-MRI
- ClinicalTrials.gov ID
- NCT07678320
- Acronym / sponsor ID
- AITECH-MRI / AITECH-MRI
- Conditions
- Whole Body Imaging, Prostate, MRI, Lung, Vascular
- Keywords
- MRI, Whole Body, Accelerated Imaging, Prostate Imaging, Vascular
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 1 Jul 2026 (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.
Single-center, cross-sectional observational study assessing the feasibility of advanced accelerated MRI sequences versus standard ones in terms of image quality, diagnostic reliability, and acquisition time.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive adults (≥18 years) admitted to the Advanced Imaging for Personalized Medicine Unit for screening WB-MRI, including a male subgroup undergoing prostate-focused imaging to rule out malignancy. Subjects refusing consent, with claustrophobia, or with metallic implants compromising image quality are excluded.
Key inclusion criteria (2 listed)
- Consecutive adults (≥18 y.o.) admitted to the UO for W MRI for screening procedure.
- Consecutive adult male patients (≥18 y.o.) admitted to the UO for WB-MRI for screening procedure and focus on prostate.
Key exclusion criteria (3 listed)
- refused to consent
- claustrophobia
- metal prosthesis potentially affecting image quality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Image quality
Time frame: 30 months
Comparison between standard and accelerated MRI sequences in terms of diagnostic accuracy, acquisition time.
1 secondary outcome
Image quality - subjective
Time frame: 30-36 months
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 16 Sep 2026.
- Background: PubMed 41374407Kim BK, Kim JS, Lee HJ, Lee JK, Lee HA, Pak S. Low- Versus High-Concentration Iodine Contrast for Hepatic Multiphase CT in Chronic Liver Disease: Image Quality, Lesion Detectability, and Iodine Load Reduction with Modern MDCT-A Retrospective Non-Inferiority Study. Diagnostics (Basel). 2025 Nov 27;15(23):3026. doi: 10.3390/diagnostics15233026.
- Background: PubMed 36841743Breit HC, Vosshenrich J, Hofmann V, Rusche T, Kovacs BK, Bach M, Manneck S, Harder D. Image Quality of Lumbar Spine Imaging at 0.55T Low-Field MRI is Comparable to Conventional 1.5T MRI - Initial Observations in Healthy Volunteers. Acad Radiol. 2023 Nov;30(11):2440-2446. doi: 10.1016/j.acra.2023.01.037. Epub 2023 Feb 24.
- Background: PubMed 41186470Haller S, Hedderich D, Federau C, Weisstanner C, Edjlali M, Cauter SV, Zaharchuk G. The Current Status of AI-accelerated MRI Techniques in Clinical Use. Radiology. 2025 Nov;317(2):e243819. doi: 10.1148/radiol.243819.
- Background: PubMed 37027426Li C, Lei S, Ding L, Xu Y, Wu X, Wang H, Zhang Z, Gao T, Zhang Y, Li L. Global burden and trends of lung cancer incidence and mortality. Chin Med J (Engl). 2023 Jul 5;136(13):1583-1590. doi: 10.1097/CM9.0000000000002529.
- Background: PubMed 35900614Rata M, Blackledge M, Scurr E, Winfield J, Koh DM, Dragan A, Candito A, King A, Rennie W, Gaba S, Suresh P, Malcolm P, Davis A, Nilak A, Shah A, Gandhi S, Albrizio M, Drury A, Roberts S, Jenner M, Brown S, Kaiser M, Messiou C. Implementation of Whole-Body MRI (MY-RADS) within the OPTIMUM/MUKnine multi-centre clinical trial for patients with myeloma. Insights Imaging. 2022 Jul 28;13(1):123. doi: 10.1186/s13244-022-01253-0.
- 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.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Whole Body Imaging and Prostate, run by IRCCS San Raffaele.
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 3 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: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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, Medicine and Surgery (+390226436185, esposito.antonio@unisr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image quality (time frame: 30 months). 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 NCT07678320, which also lists 6 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 16 Sep 2026.