AI Technologies for Enhanced and Celerated High-Field WB-MRI | NCT07678320

Studies
AI Technologies for Enhanced and Celerated High-Field WB-MRI

NCT07678320

Sponsor

IRCCS San Raffaele

Status

Not yet recruiting

Last Update Posted

Jul 1, 2026Actual

Enrollment

600Estimated

Phase

Not provided

Conditions

Whole Body Imaging
Prostate
MRI
Lung
Vascular

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2026Estimated

Primary Completion Date

Nov 1, 2028Estimated

Completion Date

May 1, 2029Estimated

First Submitted Date

Jun 25, 2026

First Submission Date that Met QC Criteria

Jun 25, 2026

First Posted Date

Jul 1, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 25, 2026

Last Update Posted Date

Jul 1, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Image quality	Comparison between standard and accelerated MRI sequences in terms of diagnostic accuracy, acquisition time.	30 months

Secondary Outcomes

Measure	Description	Time Frame
Image quality - subjective	Likert-scale evaluation of images between independent readers with different levvels of experience	30-36 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

At least 50% male population

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Antonio Esposito, Medicine and Surgery	Contact	+390226436185		esposito.antonio@unisr.it

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41374407	Background	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.
36841743