Clinical Research Directory

Scout Dose of Resin Microspheres

This study looks at a liver cancer treatment called radioembolization and tests a new, possibly more accurate way to check if the treatment is safe for a patient's lungs. Radioembolization is a procedure where tiny beads containing a radioactive substance (yttrium-90) are injected into the arteries that feed a liver tumor. These beads lodge mainly in the tumor and deliver radiation directly to it, while sparing most of the normal liver. However, some of these beads can bypass the liver circulation and travel to the lungs. If too many reach the lungs, they can cause serious radiation damage called radiation pneumonitis. To avoid this, doctors currently perform a "test run" before the real treatment. They inject a different particle called MAA into the liver artery and then do nuclear medicine scans to see how much of it goes to the lungs versus the liver. This percentage is called the lung shunt fraction. If the lung shunt is 20% or higher, radioembolization is not done; if it is between 10% and 20%, the decision depends on tumor size. The actual treatment usually happens 1-2 weeks after this test. MAA particles are similar in size to the treatment beads but not identical; some are smaller. Because of this, MAA may slightly overestimate how much of the treatment dose would really go to the lungs. Also, MAA is fully imported and has had periods of supply problems worldwide. For these reasons, there is a need for another, more accurate and more reliable way to measure lung shunt. The LASER study tests an approach called a "scout dose." In this method, doctors take a small amount of the actual treatment beads (SIR-Spheres, a resin yttrium-90 microsphere product) and inject a low radioactive dose (0.56 GBq) into the liver artery on the day of treatment. They then perform a PET/CT scan and calculate how much of this scout dose went to the lungs and how much stayed in the liver. Because the scout dose uses the same type of beads as the real treatment, it may give a more accurate picture of the true lung shunt. The study will enroll 30 adult patients who have liver tumors (liver cancer, intrahepatic cholangiocarcinoma, or liver metastases) and are already scheduled to receive radioembolization. All participants must have good liver function (Child-Pugh A), good performance status (ECOG 0-1), and an MAA-based lung shunt fraction below 20%. They also need to meet standard blood test criteria and have a life expectancy of at least three months. Each patient first undergoes the usual work-up: liver artery angiography, MAA injection, and nuclear scans, which are used to plan the treatment dose. One to two weeks later, on the treatment day, the patient has another angiogram, receives the 0.56 GBq scout dose into the liver artery, and has a scout PET/CT scan while the catheter is kept in place. After calculating the lung shunt from the scout dose, the patient is brought back to the angiography room and receives the planned treatment dose, reduced by the amount already given as the scout dose. The next morning, a treatment Y90 PET/CT scan is performed. The main measurement of interest is the lung shunt fraction calculated three different ways: from the initial MAA scan, from the scout Y90 PET/CT, and from the treatment Y90 PET/CT. The researchers will compare how closely these three values agree. They will also look at how much radiation the tumor and normal liver receive (tumor dose, normal liver dose) and the radiation dose to the lungs, again using all three imaging methods. Patients will be followed for one year with regular clinic visits, blood tests, and CT or MRI scans according to usual care. The study will carefully record side effects such as fatigue, pain, poor appetite, and more serious problems like liver failure or radiation pneumonitis, and grade them using a standard international system (CTCAE v5.0). The researchers expect that adding the scout dose and extra scan will lengthen the procedure by about two hours and cause some discomfort from lying down longer, but they do not expect a major increase in serious risks compared with standard treatment. By the end of the study, the team aims to show whether the scout dose method can safely and accurately replace or complement the traditional MAA-based test. If successful, this could improve the precision of radioembolization planning and offer a reliable alternative when MAA is not available

An Exploratory Study on Developing an Integrated Approach Combining Multimodal Imaging and Multi-omics Characterization of Tumor Heterogeneity for Precision Diagnosis and Treatment Optimization in Liver Cancer.

Primary liver cancer, mainly including hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC), represents the third leading cause of cancer-related mortality. Enhancing the precision of liver cancer diagnosis and providing early therapeutic efficacy and prognostic evaluation during clinical decision-making hold significant clinical importance. Ultrasound is the preferred imaging modality for liver cancer screening. Contrast-enhanced ultrasound (CEUS) can dynamically visualize the microvascular perfusion of liver cancer lesions. Liver elastography has become a commonly used clinical assessment tool for cirrhosis. Photoacoustic imaging (PAI), an emerging non-invasive functional imaging technique, enables visualization of specific molecules through their spectroscopic characteristics at designated wavelengths. The objectives of this study include: (1) Conducting an observational investigation combining CEUS, elastography, and superb microvascular imaging (SMI) to collect imaging data; (2) Preserving tumor specimens from participants to investigate heterogeneous protein characteristics of primary liver cancer organoids using PAI; (3) Analyzing peripheral venous blood samples to study transcriptomic profiles. Artificial intelligence (AI) technology will be employed to establish models integrating ultrasound radiomics with tumor multi-omics characteristics, aiming to provide novel strategies for precision diagnosis and treatment of liver cancer. Key questions：(1) How to develop a multimodal imaging model combining CEUS, elastography, and SMI for predicting differentiation of liver cancer, microvascular invasion (MVI) and prognosis; (2) Whether PAI can identify heterogeneous proteins in liver cancer organoids through specific spectral recognition; (3) Whether AI can integrate multi-dimensional data to establish models based on ultrasound radiomics and multi-omics features.

A Study of ICP-192 in Patients With FGFR2-Rearranged Unresectable or Metastatic Intrahepatic Cholangiocarcinoma

This is a single-arm, open-label, multi-center phase 2 clinical trial of ICP-192. The purpose of this study is to evaluate the efficacy and safety in patients with FGFR2-Rearranged unresectable or metastatic intrahepatic cholangiocarcinoma who failed prior therapy