Trial results for a study investigating electromagnetic tracking and optical imaging with Indocyanine Green (ICG) for hepatic biopsies in Liver Cancer were posted on ClinicalTrials.gov on 2026-02-02. The trial was terminated and enrolled 7 participants.
Background
Liver cancer is the sixth most common cancer worldwide. Accurate diagnosis typically requires a liver tissue sample. Obtaining an optimal sample is crucial for determining the presence and type of cancer, but the process can be challenging. This study aimed to explore the combination of two imaging devices to potentially improve the quality of liver samples.
Trial design
This terminated study, designated as Phase NA, enrolled 7 participants with Hepatocellular Carcinoma. The objective was to evaluate if combining fusion imaging and optical imaging could better sample areas of concern in the liver and determine the presence of disease.
Key results
The trial reported the following key measurements for the 'Optical Plus Fusion for Liver Biopsy' group:
- The median ratio for concordance with histopathology and Indocyanine Green (ICG) fluorescent signal at the in-vivo site of biopsy using a combination of Optical Multi-spectral Imaging (OMI) and Electromagnetic (EM) Tracking was 3.29.
- Regarding participants with concordance between histopathology outcomes and Target to Background Ratio (TBR) using ex vivo fluorescence assessment, counts of 6 and 1 participants were reported.
- 7 participants had a detectable Indocyanine Green (ICG) fluorescent signal at the in-vivo site of biopsy.
What this means
The posted results provide initial data on the use of combined electromagnetic tracking and optical imaging with ICG for hepatic biopsies. The detection of ICG fluorescent signal in all 7 participants and the reported concordance with histopathology outcomes in 6 participants using ex vivo assessment suggest a potential for this imaging approach in improving liver sampling. However, the trial's termination and very small enrollment of 7 participants mean these findings are preliminary and require further investigation in larger studies.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04258566, titled 'Electromagnetic Tracking and Optical Imaging With ICG for Hepatic Biopsies', were posted on 2026-02-02 on clinicaltrials.gov.