Clinical Research Directory

A Multicenter Prospective Study on the Performance of Spectral CT for Evaluating Treatment Response After TACE in Hepatocellular Carcinoma

By comparing the diagnostic accuracy of spectral CT and conventional CT in evaluating treatment response efficacy after TACE, this study aims to investigate the diagnostic performance of spectral CT in assessing treatment response following TACE for hepatocellular carcinoma.

Validation on Clinical Adaptability of the Foundation Model Specific to Neuroimaging Diagnosis

This clinic trial aims to investigate whether artificial intelligence (AI) diagnostic tools at neurological diseases diagnosis on brain CT/MRI can improve the work efficiency of specialized neuroimaging physicians, with a specific focus on its clinical value in distinguishing normal from abnormal findings, critical value identification, and neurological disease classification. Using pathological and/or discharge diagnoses of neurological diseases as the gold standard, an AI model will be trained on over 10,000 CT/MRI cases to achieve diagnostic performance comparable to that of neurological radiologists before being transformed and putted to use. Furthermore, clinical trials will be conducted in sub-studies (abnormal cases identification, critical value assessment, and neurological disease classification) to validate the clinical utility of AI and human-AI collaboration in the precise diagnosis of neurological disorders. The expected outcomes include reducing missed and misdiagnosis rates, enabling rapid screening of critical conditions, and achieving precise imaging-based diagnosis by using AI tools.

Cardiac CT Evaluation of EAT in AF vs. Non-AF Subjects

The goal of this cross-sectional study is to explore the relationship between atrial structural characteristics (such as epicardial adipose tissue infiltration and atrial size) and atrial fibrillation (AF), as well as the differences in these characteristics among different AF subtypes. It will also clarify the independent association between pericardial fat distribution and AF (and its subtypes) after excluding confounding factors. The main questions it aims to answer are: * What are the differences in epicardial adipose tissue volume and atrial size among patients with sinus rhythm, paroxysmal AF, and persistent AF? * Is pericardial fat distribution independently associated with AF and its subtypes after adjusting for confounding factors such as age, hypertension, and left atrial enlargement? Researchers will enroll patients who undergo coronary CTA or left atrial CTA at The Second Affiliated Hospital of Zhejiang University School of Medicine, and match and divide them into three groups (sinus rhythm group, paroxysmal AF group, and persistent AF group) based on BMI and other factors. They will compare the differences in pericardial fat distribution and baseline characteristics among the three groups and analyze the independent association between pericardial fat and AF. Participants will: * Provide relevant clinical baseline data and CTA examination results * Complete the collection of demographic information, medical history, and laboratory test data The study duration is 6 months, starting from the date of ethical approval, with an expected end date of June 2026. A total of 600-900 participants (200-300 per group) will be enrolled to ensure the reliability and clinical applicability of the research conclusions.

This is a Multicentre International Study Evaluating CT-based IGABT With / Without Either TRUS During BT/Pre BT MR as Per IBS-GECESTRO-ABS Recommendations for Target contouring-as an Alternative to MRIGABT for Cervical Cancer From Implementation Perspectives Under EMBRACE-III:TRIPLET IMPACT Study.

Title: Integration of Multi-modality Imaging Protocols with Emphasis on CT in Image-Guided Adaptive Brachytherapy (IGABT) for Cervical Cancer - EMBRACE III-TRIPLET : IMPACT Study Locally advanced cervical cancer (LACC) remains a major health challenge, particularly in low- and middle-income countries (LMICs), which account for the majority of global cases. The standard curative treatment involves a combination of external beam radiotherapy (EBRT) with concurrent chemotherapy, followed by brachytherapy (BT). Brachytherapy plays a crucial role in achieving high local control by delivering radiation directly to the tumour through internally placed radioactive sources. Historically, BT dose prescription was based on two-dimensional (2D) X-ray images and defined anatomical "points," achieving 5-year local control rates of 60-70%. Over the last decade, magnetic resonance imaging (MRI)-based image-guided adaptive brachytherapy (MR-IGABT) has transformed practice by enabling three-dimensional (3D) target-based dose prescription and adaptation to tumour regression. The landmark EMBRACE I study, involving over 1300 patients, demonstrated over 90% 5-year local control rates with MR-IGABT, establishing it as the international gold standard endorsed by NCG, ICRU, NCCN, and ESGO-ESTRO guidelines. However, MRI-based planning for IGABT remains logistically and financially challenging for many centres, especially in LMICs. CT and transrectal ultrasound (TRUS) have emerged as feasible alternatives, offering broader accessibility. Despite encouraging outcomes from smaller institutional studies, the lack of standardized and validated target delineation concepts for CT-IGABT has led to significant variability in clinical implementation. Recognizing this, the Indian Brachytherapy Society (IBS), American Brachytherapy Society (ABS), and GEC-ESTRO jointly published consensus recommendations in 2020 to standardize CT-IGABT practices across diverse clinical environments. At Homi Bhabha Cancer Hospital and Research Centre, Visakhapatnam, our prior work (RetroLACER Study) demonstrated that CT-based IGABT can achieve outcomes comparable to MR-IGABT, highlighting its feasibility and potential for wider adoption. Building on this foundation, the EMBRACE III-IMPACT Study seeks to evaluate whether CT-IGABT can be systematically and uniformly implemented in a multi-centre setting and to benchmark clinical outcomes against the standards set by MR-IGABT. Study Design: This is a multicentre, prospective, observational study planned to include approximately 1200 participants with locally advanced cervical cancer. All participants will receive standard-of-care treatment, including EBRT, concurrent weekly cisplatin chemotherapy, and brachytherapy with image-guided planning. Objectives: To assess the feasibility of implementing standardized CT-IGABT protocols across diverse clinical environments. To evaluate local control, disease-free survival, and treatment-related toxicity outcomes for CT-IGABT. To compare and benchmark CT-IGABT outcomes with established MR-IGABT benchmarks from prior international studies. Participant Involvement: Participants will undergo standard diagnostic imaging, EBRT with weekly cisplatin, and brachytherapy using CT-based planning. Imaging and treatment data will be collected, anonymized, and submitted to a central database for review. Regular follow-up visits will monitor tumour control and treatment-related side effects. Benefits: Participants receive internationally standardized, quality-assured treatment protocols. Centres gain access to expert review and QA support from international collaborators, potentially improving treatment quality and outcomes. The study supports global efforts to establish CT-IGABT as a cost-effective, accessible alternative to MRI-based IGABT, expanding equitable cancer care access. Risks: The study is observational and involves standard treatment; therefore, risks and costs are comparable to routine cervical cancer care. Confidentiality and Ethics: All data will be anonymized and handled in compliance with ethical and regulatory standards. Participant confidentiality will be strictly maintained. Written informed consent will be obtained before study participation. Significance: By validating standardised CT-based protocols and establishing outcome benchmarks, the study aims to facilitate widespread adoption of IGABT in resource-limited settings, ultimately improving treatment accessibility and survival outcomes.

CT Volume Measurement of Hepatocellular Carcinoma

The aim of this study is to evaluate the role of CT volumetric measurement in assessing treatment response of hepatocellular carcinoma (HCC) following trans arterial chemoembolization (TACE) or microwave ablation (MWA)

An Explainable Neuroradiologist Artificial Intelligence Assistance System for Brain CT and MRI

This clinic trial aims to validate the working performance of radiologists with or without artificial intelligence (AI) diagnostic tool at neurological diseases diagnosis on brain CT/MRI. Routine diagnosis workflow in real clinical scenario including imaging reading, feature interpretation, differential diagnosis, writing initial report and optimizing revised version. And the gold standards of diagnosis are the histopathology references for brain tumors and the discharge diagnosis integrating all the examination results for the other neurological diseases. The performance of AI-assisted tools on diagnosing should be examined in a clinical process with multiple aspects identical to human radiologists' work before being transformed and putted to use. This study hypothesizes that AI models, trained with over 100,000 patient scans, are non-inferior to radiologists in neurological disease diagnosis on brain CT and MRI. For the secondary end-points, we investigate the performance of AI-radiologist collaboration of reasoning-enhanced AI-assisted systems. We hypothesize that, by visualizing the process of imaging interpretation and diagnosis, reasoning-enhanced AI can not only improve working performance of radiologists but also boost their trust in AI tools.

Coronary Evaluation And Guided Lesion Exploration Using Photon-counting CT and Intracoronary Imaging Techniques

This study evaluates the diagnostic accuracy and limitations of photon-counting computed tomography (PCCT) in characterizing coronary plaque, with comparisons to optical coherence tomography (OCT) and intravascular ultrasound (IVUS). The objective is to assess whether cardiac ultra-high resolution (UHR) PCCT -with its improved spatial resolution and superior soft tissue contrast relative to conventional CT- can serve as a reliable, non-invasive alternative for coronary plaque assessment and support clinical decision-making. A total of 100 patients with either acute or chronic coronary syndrome will be enrolled, including 40 individuals with suspected in-stent restenosis and 10 patients one year post-percutaneous coronary intervention (PCI) for chronic total occlusion (CTO). All participants will undergo invasive coronary angiography based on current European Society of Cardiology guidelines. Cardiac PCCT imaging will be conducted shortly before the angiographic procedure, accompanied by invasive OCT evaluation. Additionally, a subgroup of 10 patients will undergo both OCT and IVUS, allowing for direct comparison across imaging modalities. OCT, regarded as the gold standard for plaque characterization, offers near-histological resolution for identifying plaque features, while IVUS is particularly effective in evaluating plaque burden and volume.

Energy CT in Imaging and Diagnosis of Gastric Cancer

Accurate preoperative prediction of risk stratification, treatment response, and survival prognosis in gastric cancer is important for improving clinical treatment decisions, prolonging patient survival, and improving patient quality of life. The purpose of this study is to investigate the performance of the multi-parametric magnetic resonance imaging (mpMRI) and Dual-/Muti-energy CT and photon-counting Detector CT(PCD-CT) in the diagnosis and management of gastric cancer.

Early Neuroprognostication After OHCA

This is a prospective observational substudy of the STEPCARE trial ClinicalTrials.gov Identifier: NCT05564754) with the aim to examine whether prognostication of neurological outcome after cardiac arrest can be performed earlier than the 72 h time-point recommended by guidelines today.