- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07678320
AI Technologies for Enhanced and Celerated High-Field WB-MRI (AITECH-MRI)
June 25, 2026 updated by: Antonio Esposito, IRCCS San Raffaele
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 Overview
Status
Not yet recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
600
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
- Name: Antonio Esposito, Medicine and Surgery
- Phone Number: +390226436185
- Email: esposito.antonio@unisr.it
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
Yes
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- refused to consent
- claustrophobia
- metal prosthesis potentially affecting image quality
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Image quality
Time Frame: 30 months
|
Comparison between standard and accelerated MRI sequences in terms of diagnostic accuracy, acquisition time.
|
30 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Image quality - subjective
Time Frame: 30-36 months
|
Likert-scale evaluation of images between independent readers with different levvels of experience
|
30-36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- 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.
- 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.
- Breit 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.
- Haller 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.
- Li 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.
- Rata 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.
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 (Estimated)
July 1, 2026
Primary Completion (Estimated)
November 1, 2028
Study Completion (Estimated)
May 1, 2029
Study Registration Dates
First Submitted
June 25, 2026
First Submitted That Met QC Criteria
June 25, 2026
First Posted (Actual)
July 1, 2026
Study Record Updates
Last Update Posted (Actual)
July 1, 2026
Last Update Submitted That Met QC Criteria
June 25, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- AITECH-MRI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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