Real-World Evidence from 80,000+ Whole-Body MRIs: Application of a Clinically Significant Diagnosis Scale

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August 28, 2026

Conference Abstract - ISMRM 2026

Authors -  Madhurima Datta1; Yosef Chodakiewitz1; Rodrigo Solis Pompa1; Pratik Shingru1; Vikash Modi1; Amar Patel1; Giuliana Zaccardelli1; Daniel J. Durand1; Alex Exuzides1

1 Prenuvo, Inc, San Francisco, United States of America

Background: Screening whole-body MRI (sWB-MRI) offers a noninvasive, radiation-free, and contrast-independent method for multi-organ assessment within a single diagnostic session,

facilitating the proactive identification of both malignant and benign pathologies. Although established for high-risk cohorts with hereditary predispositions such as Li-Fraumeni syndrome, the utility of sWB-MRI for general health surveillance lacks comprehensive investigation. In this study, we analyzed radiologically categorized results from a cohort exceeding 80,000 asymptomatic individuals across North America. This investigation utilizes the most expansive dataset currently available to examine preventive sWB-MRI applications, emphasizing the prevalence and medical significance of observations categorized via standardized structured reporting and rigorous clinical protocols.

Methods: A retrospective analysis was conducted on sWB-MRI data collected from January 2024 through June 2025 across 21 Prenuvo facilities. Imaging was performed

using standardized, contrast-free multiparametric MRI protocols on 1.5T Siemens (22%) or Philips (78%) systems. The cohort included head-to-ankle whole-body (WB) acquisitions (92%), head-to-thigh (HT) scans (4%), and whole-torso (WT) protocols (4%). Core sequences across all exams comprised STIR, T1, Dixon, DWI, and T2; WB and HT protocols further included Brain FLAIR and TOF MRA, while WB scans incorporated sagittal spine imaging. Philips-based examinations utilized 3D MRCP and liver PDFF, whereas Siemens systems employed pancreas T2 FS HASTE. Radiologic interpretation utilized a structured framework featuring two distinct indices: a proprietary Clinically Significant Diagnosis (CSD) scale and the validated ONCORADS oncologic stratification system. The five-point CSD scale ranges from CSD 1–2 (minimal or no screening significance) to CSD 3 (low-concern findings requiring clinical correlation). Higher-tier categories include CSD 4 (moderate-concern findings warranting timely diagnostic intervention) and CSD 5 (major-concern observations requiring urgent follow-up). Within this integrated reporting architecture, the ONCORADS scale provided specific, complementary risk assessment for oncologic-specific pathologies.

Results: Among 81,786 individuals 56% were females, with a mean age 51 ± 13 and 56% identified as Caucasian. BMI distribution was as follows: 2% underweight

(BMI < 18.5), 48% normal weight (18.5–25), 35% overweight (25.1–30), 14% obese (30.1–40), and 1% severely obese (40.1–60). Overall, 61% of individuals (49,915 participants) had findings categorized as CSD ≥ 3, signifying some degree of potential clinical relevance. Most of these represented CSD 3 findings, warranting discussion with a primary care provider, while only 4.5% (3,698) had at least one CSD 4 finding that warranted dedicated diagnostic follow-up and 0.3% (267) had at least one CSD 5 finding requiring urgent expedited follow-up. The prevalence of CSD ≥ 4 findings within each category demonstrated a rising trend with increasing age: 18–24 (1.8%), 25–34 (2.1%), 35–44 (2.8%), 45–54 (4.5%), 55–64 (6.7%), 65–74 (10.4%), 75+ (14.6%).

CSD ≥ 3 findings most commonly involved the spine (22%), liver (16%), and thyroid (10%). Among these, cervical spondylosis accounted for 44% of spinal cases, hepatic steatosis for 92% of liver cases, and nodules for 95% of thyroid cases.In the oncologic risk stratification analysis, ONCORADS ≥ 4 findings indicating potential or highly suspicious for malignancy were identified in 2.2% (1,776 individuals) . The prevalence of ONCORADS findings ≥ 4 also increased with age: 18–24 (0.5%), 25–34 (0.5%), 35–44 (1%), 45–54 (1.9%), 55–64 (3.3%), 65–74 (5.5%), 75+ (7.5%).Among males, ONCORADS ≥ 4 findings were most commonly observed in the prostate (53%), followed by the lungs and mediastinum (9.2%) and kidneys (7.3%), while in females, the most frequent sites were the lungs and mediastinum (20%), breasts (13%), and brain (8%).

Discussion: This large multicenter analysis demonstrates the feasibility and clinical utility of standardized sWB-MRI in a general preventive health population. The results confirm that while most individuals exhibit findings of some clinical relevance, only about 5% require direct diagnostic work-up, highlighting the effectiveness of structured MRI reporting systems in balancing sensitivity with clinical specificity. The novel internally developed CSD framework provides a unified method for grading preliminary screening-diagnostic severity and follow-up urgency, ensuring consistent communication across radiologists and clinics. Notably, higher ONCORADS findings were also frequently observed in organs such as the kidney that do not have traditionally utilized targeted screening programs, suggesting that sWB-MRI may complement existing population-based cancer screenings via an imaging-based Multi-Cancer Detection (MCD) strategy. Future work will explore longitudinal outcomes to determine sensitivity and specificity along with cost-effectiveness to optimize the role of sWB-MRI in preventive healthcare.

Conclusions: sWB-MRI enables comprehensive, radiation-free assessment across multiple organ systems, with only 5% of individuals requiring further diagnostic work-

up. The structured CSD and ONCORADS frameworks support consistent reporting and clinical triage.

References:

1. Zugni F, Padhani AR, Koh DM, Summers PE, Bellomi M, Petralia G. Whole-body magnetic resonance imaging (WB-MRI) for cancer screening in asymptomatic subjects

of the general population: review and recommendations. Cancer Imaging. 2020;20(1):34.doi: 10.1186/s40644-020-00315-0

2. Ballinger ML, Best A, Mai PL, et al. Baseline Surveillance in Li-Fraumeni Syndrome Using Whole-Body Magnetic Resonance Imaging: A Meta-analysis. JAMA Oncol.

2017;3(12):1634–1639. doi:10.1001/jamaoncol.2017.1968

3. Petralia G, Koh DM, Attariwala R, et al. 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;299(3):617-628. doi: 10.1148/radiol.2021201740

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