Liver cancer is one of the leading causes of cancer-related deaths globally, particularly for patients with chronic hepatitis and cirrhosis. Accurate assessment of liver function prior to treatment is crucial to prevent liver failure due to insufficient residual liver function after therapy. Traditional methods for liver function evaluation, such as liver function blood tests, indocyanine green retention tests (ICGR15), or CT/MRI scans, often lack sufficient sensitivity and specificity and can be affected by various factors, making it challenging to accurately reflect liver function. Thus, there is an urgent need for a tool that can accurately assess liver function.

To address this issue, NARI’s Isotope Application Division has developed "Dolacga" for functional liver imaging. Its core component is a hexa-lactosyl-peptide derivative, which features galactose moieties that are specifically recognized by hepatic asialoglycoprotein receptors (ASGPRs). This specificity allows for precise targeting of the liver. When Dolacga is reconstituted with the radioactive isotope gallium-68 and used with positron emission tomography/computed tomography (PET/CT), it provides detailed imaging of ASGPR distribution in the liver.
Figures 1 and 2 illustrate the structure of Dolacga and the asialoglycoprotein receptor, respectively.
 

The ASGPR is a specific receptor located on the liver cell membrane, primarily responsible for clearing aged glycoproteins from the blood. Its expression is highly correlated with liver function, and a reduction in ASGPR levels is indicative of liver damage. By leveraging this characteristic, PET/CT imaging with Ga-68-Dolacga allows for accurate assessment of liver function and the degree of liver impairment.

Dolacga’s innovative technology has been awarded over 20 patents and numerous domestic and international accolades, underscoring its potential in the field of liver function assessment. Its technical advantages include high specificity, low background absorption, and high sensitivity. Additionally, Dolacga features an "immediate-use" gallium-68 labeling process that requires only 15 minutes, eliminating the need for further purification. In 2024, Dolacga completed Phase II clinical trials for preoperative liver function assessment in hepatocellular cancer (HCC) patients. Preliminary results indicate that Dolacga can significantly differentiate between normal liver tissue and cancerous regions, providing precise quantitative information on liver function to support surgical planning.

Beyond preoperative liver function assessment for liver cancer, Dolacga also holds potential value for patients undergoing proton therapy or chemotherapy for cancer. Both treatments require precise pre-treatment liver function evaluation to prevent excessive liver damage. Dolacga can aid physicians in making more accurate decisions for these treatment modalities, thereby ensuring the safety and efficacy of the therapeutic process.
 

NARI is committed to broadening the clinical applications of Dolacga. Since 2024, we have been collaborating with Linkou Chang Gung Memorial Hospital on a clinical trial evaluating residual liver function in liver cancer patients before and after proton therapy. To date, 10 participants have been enrolled, with preliminary results indicating that Dolacga can effectively assess both global and regional liver function changes following treatment. Recruitment of participants is ongoing. This year, we will also launch two clinical studies assessing liver function prior to chemotherapy and radiofrequency ablation in cancer patients, further exploring Dolacga’s potential in diverse treatment settings.

In parallel, we are establishing a stable drug supply platform and fostering close collaboration with major medical centers nationwide to promote the use of this technology in the diagnosis and treatment planning of liver diseases. Looking ahead, we aim to continuously enhance the formulation’s performance, expand into international markets, and integrate artificial intelligence (AI) for automated image recognition and analysis—ultimately improving the efficiency and accuracy of liver function assessment and delivering a more precise and convenient diagnostic solution for the global medical community.