# GPC3 imaging of the indeterminate liver nodule, led from China

Source: https://nuclide.cc/opportunities/opp-gpc3-hcc-china/  
Nuclide record `opp-gpc3-hcc-china` (Opportunity). Data CC BY-NC 4.0, attribute "Data from Nuclide (nuclide.cc)"; commercial use needs a licence.

## TL;DR

Cirrhotic livers throw up nodules that scans cannot classify, and the usual answer is to wait three to six months to see if they grow. Several Chinese hospital programmes are testing tracers that recognise a protein carried by most liver cancers, and almost none of that work appears in Western pipeline reviews.

## Summary

This record exists partly to demonstrate the non-US-registry lens. The clinical problem is well defined: using the CT/MRI LI-RADS algorithm, the pooled proportion of hepatocellular carcinoma is 31% for LR-3 and 64% for LR-4 observations, so a large share of nodules sit in categories that neither confirm nor exclude cancer, and the management default is serial imaging. Glypican-3 is overexpressed in 70 to 80% of hepatocellular carcinomas and virtually absent in normal adult liver and benign hepatic lesions, which is an unusually clean contrast for a liver target.

The programmes divide along geography. The most mature single dataset is Western: [68Ga]Ga-RAYZ-8009 from RayzeBio, now part of Bristol Myers Squibb, with a 24-patient first-in-human case series run in the Netherlands and Germany, no adverse events, and tumour-to-liver ratios averaging 8.3 at about an hour. A related investigator-initiated cohort in India reported 64 patients scanned with 92% showing at least one positive lesion. But the deepest programme is at Wuhan Union Hospital: 68Ga-XH06, an antibody-fragment immunoPET agent registered as NCT06383520 with 100 patients estimated, published as a 5-patient pilot in EJNMMI and an 8-patient first-in-human study in Clinical Cancer Research, with conference cohorts of 30 and 36 patients reporting sensitivity of 90.63% and specificity of 100% against pathology in one data cut and 91.7% and 83.3% in another. A head-to-head against enhanced MRI is registered at 150 patients, and a further 40-patient study is recruiting at Xiamen.

No GPC3 imaging agent has FDA, EMA or NMPA marketing approval. The point of the record is that a landscape review built only on ClinicalTrials.gov Western entries would see the 24-patient case series and miss the registered 100- and 150-patient Chinese studies behind it.

## Fields

- Kind: Opportunity
- Last checked: 2026-09-23
- Also known as: GPC3 PET; glypican-3 imaging
- Tags: non-US registry; liver; China; indeterminate nodule

## Sources

- LI-RADS: pooled proportion of hepatocellular carcinoma by category, Radiology 2023: https://pubs.rsna.org/doi/full/10.1148/radiol.222801
- [68Ga]Ga-RAYZ-8009 first-in-human case series, J Nucl Med 2024: https://pubmed.ncbi.nlm.nih.gov/39362766/
- NCT06383520: GPC3-targeted PET imaging in hepatocellular carcinoma, Wuhan: https://clinicaltrials.gov/study/NCT06383520
- NCT07352345: GPC3 PET against enhanced MRI, 150 patients: https://clinicaltrials.gov/study/NCT07352345
- GPC3-targeted immunoPET translational study, EJNMMI 2026: https://pubmed.ncbi.nlm.nih.gov/41688850/

## Connected records

- isotopes: [Gallium-68](https://nuclide.cc/isotopes/ga-68/)
- indications: [Hepatocellular carcinoma](https://nuclide.cc/indications/hcc/)
- technologies: [Immuno-PET](https://nuclide.cc/technologies/immuno-pet/), [PET/CT](https://nuclide.cc/technologies/pet-ct/), [PET/MRI](https://nuclide.cc/technologies/pet-mri/)
- targets: [Glypican-3](https://nuclide.cc/targets/gpc3/)

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