# No clinical claims for imaging-derived biomarkers without phantom and standards compliance

Source: https://onco.cc/ideas/idea-tr2-radiomics-ibsi-mandate/  
OnCo record `idea-tr2-radiomics-ibsi-mandate` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Thousands of papers extract 'radiomic' features from scans to predict outcomes, but the features change with scanner settings. Journals should require standard compliance before any clinical claim is made.

## Summary

Radiomic features vary with acquisition, reconstruction and software; the Image Biomarker Standardisation Initiative (IBSI) defined reference values and benchmark datasets, but most published radiomics studies do not report compliance or test-retest reproducibility. Journals and funders requiring IBSI compliance, phantom-based feature stability testing and external validation for any radiomic biomarker claiming clinical relevance would cut the noise.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: Adopting the requirement will reduce the number of published radiomic signatures by more than half and increase the fraction that replicate in external cohorts from a small minority to a majority.
- Rationale: The field's replication crisis is well documented in systematic reviews; the standards exist and are unenforced.
- Proposed test: Two radiology journals adopt the requirement; compare external validation rates of signatures published before and after.
- Maturity: early-clinical
- Actor: research

## Sources

- Image Biomarker Standardisation Initiative: https://theibsi.github.io/

## Connected records

- companies: [Aidoc](https://onco.cc/companies/aidoc/), [Lunit](https://onco.cc/companies/lunit/)
- technologies: [CT (computed tomography)](https://onco.cc/technologies/ct/), [MRI](https://onco.cc/technologies/mri/), [PET/CT](https://onco.cc/technologies/pet-ct/)
- bottlenecks: [AI that is built but not validated or deployed](https://onco.cc/bottlenecks/b-ai-validation/), [Biomarkers are not validated or standardised](https://onco.cc/bottlenecks/b-biomarker-validation/)

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