Clinical Research Directory

A Phase III Randomised Clinical Trial of Ultrasound Groin Monitoring Versus Groin Lymph Node Dissection to De-Escalate the Extent of Surgery in Vulvar Cancer

This study is a phase III, open label, multicentre, three-group, randomised clinical trial. The primary aim of this study is to determine whether intensive groin ultrasound monitoring (1) is effective and safe to replace invasive groin lymph node dissection (LND) to manage vulvar cancer, (2) decreases the morbidity associated with vulvar cancer surgery, and (3) is cost effective.

PET-CT Predicting Lymph Nodes Metastasis

This study is a single-center prospective clinical study that aims to evaluate the predictive value of preoperative 18F-FDG-PET-CT and 18F-FAPI-PET/CT for lymph node metastasis in patients with non-small cell lung cancer. The final pathological results were used to assess the predictive value of PET-CT for lymph node metastasis.

Maximizing Lymph Node Dissection on Fresh and Fixed Lung Cancer Resection Specimens

Lung cancer patients undergoing upfront surgery, highly benefit from a systematic lymph node dissection in the mediastinum and in the surgical specimens. The latter is performed by the pathologist. Developing a standardized technique to dissect the lobectomy specimen has the potential of maximizing the retrieval of all N1 stations lymph nodes. The investigators believe that the adoption of such technique will improve lung cancer staging and identify a higher number of patients that qualify for adjuvant therapies.

NODE (groiN ultrasOunD cancEr)

This study is an open label, prospective, experimental, randomised clinical trial. The primary aim of this study is to determine whether it is feasible to randomise vulvar cancer patients into one of two treatment arms:1) surgical groin node dissection (as delivered though either a sentinel node biopsy or inguinofemoral lymph node dissection (IFL), or 2) serial high-resolution bilateral groin ultrasound surveillance and clinical examination every 2 months for 12 months.

Propranolol With Tislelizumab Plus GC in Neoadjuvant Bladder UC

This is a prospective, multicenter, Phase Ib clinical study designed to evaluate the safety and preliminary efficacy of propranolol combined with tislelizumab plus gemcitabine/cisplatin (GC) as neoadjuvant therapy for patients with bladder urothelial carcinoma with clinical lymph node involvement (cT1-T4aN1-3M0). Current neoadjuvant immunochemotherapy regimens can improve clinical outcomes in cisplatin-eligible patients; however, patients with lymph node metastasis show a significantly poorer pathological complete response (pCR) rate compared with non-metastatic cases. Real-world clinical observations have shown that more than 20% of patients achieve complete response in the primary tumor after immunotherapy but have persistent or progressive positive lymph nodes, suggesting unique resistance mechanisms within lymph node metastatic lesions. Preclinical studies conducted by our team demonstrated that sympathetic innervation within lymph nodes releases norepinephrine, which activates β-adrenergic signaling in metastatic tumor cells and promotes lipid metabolic reprogramming, leading to CD8⁺ T-cell exhaustion and immune resistance. Propranolol, a non-selective β-adrenergic blocker, may reduce metabolic stress and restore antitumor immunity, potentially enhancing the efficacy of immune checkpoint blockade. In this study, enrolled patients will receive oral propranolol in combination with intravenous tislelizumab and standard GC chemotherapy prior to surgery. Participants will be closely monitored for treatment-related adverse events, including cardiovascular events, hematologic toxicity, and immune-related reactions. The primary endpoint is dose-limiting toxicity (DLT). Secondary endpoints include pathological complete response (pCR), pathological downstaging, safety, and survival outcomes. Exploratory analyses will evaluate changes in immune cell populations in tumor tissues, lymph nodes, and peripheral blood. The results of this study aim to provide evidence for new neoadjuvant strategies targeting lymph node metastatic bladder cancer and support the development of personalized therapeutic approaches.

Molecular Residual Disease Assessment in a Representative Diverse Population of Patients With Early-stage Breast Cancer

The purpose of this study is to determine how circulating tumor DNA (ctDNA), a sign of minimal residual disease (MRD), is detectable after surgery in patients with early HR+/HER2- breast cancer that has spread to 1-3 lymph nodes. Researchers aim to understand if ctDNA detection can identify patients at higher risk of recurrence and guide better treatment decisions. A key aspect is the inclusion of a dedicated cohort of African American/Black women, a group underrepresented in molecular residual disease (MRD) research despite experiencing more aggressive breast cancers. This study will correlate ctDNA results with treatment patterns (radiotherapy, systemic therapy) and outcomes (recurrence-free and overall survival) in both non-African American and African American participants.

Irreversible Electroporation for Recurrent or Metastatic Cervical Lymph Node Metastases From Thyroid Cancer: A Prospective Multicenter Single-Arm Study

This is a single-arm, open-label, multicenter, exploratory clinical trial designed to systematically evaluate the efficacy, safety, and patient benefit of ultrasound-guided irreversible electroporation (IRE) ablation for recurrent or metastatic cervical lymph node disease in patients with thyroid cancer after prior curative thyroid surgery and neck dissection. A total of 85 participants will be enrolled. After providing written informed consent, participants will enter a screening period of up to 28 days. During screening, baseline imaging of target lymph nodes will be performed (contrast-enhanced ultrasound or computed tomography), and patient-reported and clinician-reported assessments will be completed, including quality of life, pain, neck appearance, and, when applicable, voice-related outcomes. Laboratory testing and immunology samples will also be collected. Eligible participants will undergo the first IRE ablation on Day 0 under ultrasound guidance. Acute pain will be assessed using the Numeric Rating Scale (NRS) at 0, 4, 8, 24, 48, and 72 hours after the procedure, and all adverse events and device deficiencies will be recorded. The first imaging re-assessment will be performed at Day 30 (±7 days). If residual enhancement suggests incomplete ablation, one salvage IRE ablation may be performed within 14 days. After confirmation of no need for salvage ablation or after completion of salvage ablation, participants will enter follow-up. Follow-up visits will occur every 3 months starting from Month 3 after the first (or salvage) ablation and will continue until 24 months or until imaging progression, withdrawal, death, or loss to follow-up, whichever occurs first. Imaging assessments will be performed at each follow-up visit. At 12 months, the volume reduction rate (VRR), complete disappearance rate, and recurrence rate of treated lymph nodes will be assessed. Patient-reported outcomes (ThyPRO-39, EQ-5D-5L, neck appearance satisfaction visual analog scale) and clinician-reported scar assessment (Vancouver Scar Scale) will be repeated at Months 1, 3, 6, and 12, with the Voice Handicap Index-10 collected as needed. Laboratory tests (blood count, biochemistry, electrolytes) and immunology samples will be collected every 3 months. The primary efficacy endpoint is the lymph node volume reduction rate at 12 months after a single IRE ablation. Secondary efficacy endpoints include 12-month lymph node volume reduction rate after single and/or salvage ablation, complete disappearance rate and recurrence rate at 12 months, volume reduction rate at 12 months for lesions located in high-risk anatomical areas, progression-free survival and overall survival, and improvements in quality of life and cosmetic outcomes. Safety endpoints include the incidence of adverse events and serious adverse events graded by NCI CTCAE v5.0, device-related serious adverse events, acute pain tolerability (NRS area under the curve and the proportion of participants with NRS ≥4 of sustained duration), laboratory abnormalities, and changes in voice-related outcomes. Exploratory endpoints include longitudinal changes in immune cell subsets, immune checkpoint and inhibitory molecule expression, and serum cytokine/chemokine profiles. Adverse events will be followed from the last IRE procedure (including salvage ablation) through 12 months.

LN-RADS, RECIST 1.1 and Node-RADS Classification in the Assessment of Lymph Nodes

The project aims to evaluate the value of the new LN-RADS scales for lymph node classification in CT and MR and to compare this method with two other methods RECIST 1.1 and Node-RADS. The main tested system in the study is LN-RADS, the comparators are RECIST 1.1 and Node-RADS criteria. Lymph nodes are a key diagnostic and therapeutic element in oncology. Despite the technological progress, the detection of neoplastic changes in the lymph nodes is of low effectiveness, which results from the imperfection of the criteria used. Currently, the most widely used criterion is the RECIST 1.1 guideline developed in the 1990s, according to which the lymph node dimension in the short axis with a cut-off point of 10 mm is decisive. Lymph nodes smaller than 10 mm across are considered normal. It is a criterion with a high error rate, both due to the false-negative diagnoses (with small metastases below 10 mm) and false-positive diagnoses (in the case of inflammatory lymphadenopathy). A particular disadvantageous situation is when the metastatic nodes and their transverse dimension is less than 10 mm, because they are treated as healthy nodes and the degree of the disease advancement is underestimated. As a result, the patient is not treated properly - no complete lymphadenectomy, no radiotherapy to the area of these nodes or insufficient systemic treatment. In all cases, underestimating the stage of the neoplastic diseases increases the risk of the recurrence. LN-RADS accounts small metastases in nodes about 3 mm in size, thus about 20% more metastatic nodes may be detected compared to RECIST 1.1 method. This means that currently, according to RECIST 1.1 rules, approx. 20% of patients have missed nodal metastases and consequently receive insufficient treatment resulting in relapse. Previous studies have shown that RECIST 1.1 shows a high level of underestimation of metastatic nodes. The Node-RADS system, as the second comparator next to RECIT 1.1, is a fairly new system moving towards the structural assessment of lymph nodes, but proposed arbitrarily, without hard evidence for its effectiveness. Despite the publication of the Node-RADS system in a medical journal, it is not validated. The Node-RADS has numerous limitations and weaknesses that reduce its value.

Lymph Node Metastasis in Early Esophageal Squamous Cell Carcinoma

This study aims to develop a predictive model using deep learning and radiomics to assess the likelihood of lymph node metastasis in patients with early-stage esophageal squamous cell carcinoma (ESCC). Lymph node metastasis is a critical factor in determining the treatment approach and prognosis for ESCC patients. By analyzing medical imaging data, we hope to create a non-invasive method that can assist doctors in making more accurate treatment decisions. This research could improve patient outcomes by enabling earlier and more tailored interventions.

Image-guided Ultrasound Robotic Intraoperative Evaluation of Lymph-nodes Status in Gynecological Malignancies

The assessment of lymph node status is of crucial importance in gynaecological malignancies. Indeed, the prognosis and adjuvant treatment regimens are strongly influenced by the presence of nodal involvement. Systematic extensive lymphadenectomies are often performed for staging, diagnosis of skip metastases and to define the radiation field when radiotherapy treatments are required. Nevertheless, these can lead to significant short-term and long-term lymphatic complications, which are difficult to justify if the lymph nodes are free from metastasis. To avoid unnecessary comprehensive procedures in early-stage cancers, evaluation of the sentinel lymph node has acquired a valuable role even if limitations are still present (rate of frozen section false negative, "empty packets" and mapping failure). The introduction of an intra-operative non-invasive imaging technique capable of describing the presence and characteristics of lymph nodes could help in (1) eliminating the risk of empty packet, (2) orienting the intraoperative decision while avoiding the drawbacks of frozen section (time and resources, partial destruction of the tissue material), (3) orientate the pathological section if frozen section is used. To date, technological advancements have paved the way for enhanced intra-operative assessment of cancerous organs and lesions. Over the past decade, the evolution of robotic surgery combined with advancements in image-guided surgery techniques has led to the introduction of ultrasound probes designed specifically for intraoperative ultrasound during robotic surgery (RIOUS). Apart from the conventional rigid laparoscopic probes, which can be inserted through an accessory trocar, there are robotic probes tailored to fit device arms, and drop-in flexible probes that are becoming increasingly relevant in the scientific panorama. Notably, the latter drop-in probes feature a rigid segment designed for compatibility with robotic graspers, leveraging the dexterity and rotational manoeuvrability inherent to robotic surgery. Such probes, already proven effective in evaluating liver and kidney lesions as well as tumour margins, hold promise for intraoperative lymph node assessments due to the possibility of reaching difficult anatomical spaces thanks to the robotic-assisted movements

Adjuvant Immunotherapy Combined With ChemoRadiation for Patients With High-risk Resectable Extrahepatic Cholangiocarcinoma（AICRC）

The purpose of this prospective, observational study is to investigate whether adjuvant chemoradiotherapy combined with immunotherapy for high-risk recurrence populations after extrahepatic cholangiocarcinoma resection can improve patients' recurrence-free survival. The primary study endpoint of this prospective study is the 2-year recurrence-free survival.

SUper-Resolution Ultrasound Imaging of Erythrocytes (SURE) in Normal and Malignant Lymph Nodes

The goal of this observational study is to visualize the small vessels in normal and cancerous lymph nodes on the neck with a new ultrasound technique. The main questions it aims to answer are: * Is it possible to visualize the network of the smallest vessels in lymph nodes on the neck? * Is it possible to distinguish between healthy and cancerous lymph nodes using different parameters? The participants will have 1-2 lymph nodes ultrasound scanned with a standard ultrasound technique and the new technique.

Pilot Study of MPB-2043 Enhanced MRI for Nodal Staging in Head and Neck Squamous Cell Carcinomas

This study evaluates the safety and effectiveness of MPB-2043, a superparamagnetic iron oxide (SPIO) contrast agent, for enhancing MRI in detecting metastatic lymph nodes in head and neck cancer. The study compares four doses of MPB-2043 (0.5 mg/kg, 1 mg/kg, 2 mg/kg, and 3 mg/kg) and assesses the optimal timing for post-dose imaging using T1/T2/T2\*-weighted sequences to improve the accuracy of nodal staging.

AI-Based Prediction of Lymph Node Metastasis in Gastric Cancer Using Preoperative Multimodal Data

This study aims to develop and validate an artificial intelligence (AI) system that can predict whether lymph node metastasis has occurred in patients with gastric cancer before surgery. Using preoperative imaging and pathology data, the AI models will not only predict if metastasis is present but also identify which specific lymph node stations or individual lymph nodes are involved. All lymph nodes will be carefully removed during surgery and examined one by one with detailed pathological methods to ensure accurate diagnosis. The goal is to improve the accuracy of lymph node assessment and assist doctors in making better treatment decisions.

Clinical Relevance of Pathologic Regression IN Lymph Node for Locally Advanced Rectal Cancer

We evaluated all related clinical and pathologic data of patients with Locally Advanced Rectal Cancer following Neoadjuvant Chemoradiotherapy, including the pathologic regression grading in the primary tumor site and lymph node, and other histopathologic characteristics. Finally, the present study was aimed at (1) clarifying the clinical significance of the Major Pathologic Regression for Locally Advanced Rectal Cancer following Locally Advanced Rectal Cancer in the primary tumor site and lymph node, and (2) comparing different Neoadjuvant Chemoradiotherapy treatments of this uncommon disease through conducting a large, multi-center cohort study.

A Deep Learning Model for Diagnosing Lymph Node Metastasis in Nasopharyngeal Carcinoma(NPC)

(I) AI Model for Diagnosing Lymph Node Metastasis We developed an AI model to help diagnose whether a single lymph node in nasopharyngeal cancer has spread. The model uses MRI images of the lymph node and the area around it. It includes: 1.Automatically identifying the lymph nodes and the primary tumor. 2.Analyzing MRI images of the lymph node and surrounding area. 3.Using MRI scans before and after chemotherapy to track changes in the lymph node. (II) AI Model for Predicting Lymph Node Metastasis We created an AI model that predicts whether a lymph node in a specific area has cancer. This model uses a combination of the primary tumor's pathology and MRI images of both the tumor and lymph node. It also tracks changes in the lymph node over time. The model includes: 1.Analyzing the tumor's pathology to identify specific lymphatic structures. 2.Using MRI scans to predict the likelihood of metastasis in a single lymph node. 3.Examining MRI scans before and after chemotherapy to help determine if the lymph node has metastasized. (III) Verifying and Analyzing the Benefits of the AI Model We are testing the AI model to see how well it works and its potential benefits, including: 1.Checking if the AI can correct past diagnoses of recurrent lymph nodes in nasopharyngeal cancer, which could help guide treatment plans for radiotherapy. 2.Testing the model using biopsy results from head and neck cancer patients to see if it can accurately detect negative lymph nodes. 3.Running clinical trials to test the AI model's safety and effectiveness in guiding radiation treatment for upper neck and single lymph node areas in nasopharyngeal cancer. 4.Analyzing the economic benefits of using the AI model in radiation treatment for nasopharyngeal cancer.

Axillary LNs Evalution in Breast Cancer by Multimodal Us

The present study is designed to evaluate the role of simultaneous multi-modal sonographic tools-Ultrasound (US), Color Doppler Ultrasound (CDU), and Ultrasound Elastography (UE)-in determining the nature (benign or malignant) of axillary lymph nodes (ALNs) in patients with primary breast cancer. It aims to compare the diagnostic indices of each modality individually against their combined performance. Specifically, the study will assess whether adding UE to conventional gray-scale US and CDU improves diagnostic accuracy.

Neck Observation or Elective Neck Dissection in CT1N0M0 OSCC

To evaluate the clinical outcomes of 2-year lymph node metastasis rate, disease-free survival, overall survival, and health-related quality of life in the patients with cT1N0M0 oral squamous cell carcinoma, who receive primary lesion resection combined with elective neck dissection or primary lesion resection only.

Comparison of the Accuracy of US, MRI and PET/CT in the Assessment of LNs in Cervical Cancer.

Lymph node involvement is the most important negative prognostic factor in cervical cancer. Reliable preoperative lymph node assessment is of utmost importance to tailor the treatment. According to the current European guidelines local extent of the disease can be assessed by magnetic resonance imaging (MRI) or by ultrasound (US), if performed by properly trained sonographer. Positron emission tomography combined with computed tomography (PET/CT) is used as a reference standard for preoperative evaluation of lymph nodes. Another technique to assess nodes combining morphological and functional characteristics is diffusion-weighted MRI (DW/MRI). While US is considered the adequate alternative to MRI in local staging of cervical cancer, there is no relevant evidence of diagnostic performace of US in nodal assessment. However, retrospective analysis of diagnostic accuracy of US from our site brought promising results. Furthermore, there are no trials prospectively investigating these three imaging methods in the same study population. The CANNES study is a prospective multicenter trial comparing diagnostic accuracy of US, PET/CT and DW/MRI in preoperative assessment of pelvic lymph nodes in cervical cancer. The study is designed to establish new standard in preoperative assessment of pelvic lymph nodes in patients with cervical cancer. Ninety-one patients will be enrolled into the study within 36 months and each of them will undergo all three imaging methods. To avoid a bias all imaging examinations will be conducted independently and blinded among sonographers, radiologists and nuclear medicine physicians. By contrast, each surgeon will have all reports from imaging available before procedure to be used as a navigation. Surgical procedures will include sentinel lymph node biopsy, debulking/sampling or systematic dissection of pelvic nodes following current European guidelines.

Evaluation of Axillary Lymph Node Metastasis Status of Breast Cancer Based on Pathological Images and Virtual Staining

The goal of this observational study is to develop an artificial intelligence model to transform unstained lymph node tissue slice images directly into stained images. The main questions it aims to answer are: Can the virtual staining model generate hematoxylin and eosin (H\&E) and immunohistochemistry (IHC) images suitable for clinical diagnosis from unstained paraffin-embedded lymph node slice images, including those from breast axillary lymph nodes and other tumor lymph nodes? Can the virtual staining model generate H\&E and IHC images suitable for clinical diagnosis from unstained frozen sentinel lymph node slice images from breast cancer patients? Researchers will retrospectively collect paraffin-embedded lymph node slices from tumor patients and prospectively collect frozen sentinel lymph node slices from breast cancer patients.

Prediction of Non-sentinel Lymph Node Metastatic Status of Breast Cancer Based on Pathology-MRI Images

The goal of this observational study is to develop an artificial intelligence model based on pathology and magnetic resonance imaging (MRI) images to predict the metastatic status of non-sentinel lymph nodes in patients with breast cancer sentinel lymph node metastasis. The main questions it aims to answer are: Can an artificial intelligence model based on MRI images of breast cancer patients predict the non-sentinel lymph node metastatic status in patients with breast cancer sentinel lymph node metastasis? Can an artificial intelligence model based on intraoperative frozen section images of sentinel lymph nodes in breast cancer patients predict the non-sentinel lymph node metastasis status in patients with sentinel lymph node metastasis from breast cancer? Can artificial intelligence models based on preoperative MRI and intraoperative frozen section images of sentinel lymph nodes in breast cancer patients predict the non-sentinel lymph node metastatic status in patients with sentinel lymph node metastasis from breast cancer? Researchers will retrospectively and prospectively collect preoperative MRI and intraoperative sentinel lymph node section images from breast cancer patients.

Improvements in Thyroid Tumor Surgery and the Prognosis, Diagnosis, Recurrence and Metastasis of Patients

The objective of this research is to investigate the clinical outcomes of modified surgical techniques such as omitting the cervical linea alba suture in transthoracic endoscopic thyroidectomy. Furthermore, the study requires the collection of normal thyroid tissues, benign and malignant thyroid tumors, and lymph nodes to further clarify the mechanisms associated with the initiation, progression, metastasis, and recurrence of thyroid cancer.

Development of an Imaging Prediction Model for Pelvic Lymph Node Metastasis of Cervical Cancer Using Artificial Intelligence Techniques.

This study is a retrospective exploratory trial conducted at a single center, aiming to develop and validate a preoperative lymphatic metastasis model for cervical cancer using artificial intelligence deep learning. The model is trained using preoperative imaging and postoperative pathological findings of cervical cancer patients, with the goal of enhancing the accuracy of lymphatic metastasis prediction through preoperative imaging and offering insights for treatment decisions.

Study on the No.253 Lymph Node Metastasis Patterns in Left-Sided Colon and Rectal Cancer

The goal of this observational study is to learn about the the pattern of metastasis of the No.253 lymph node in colorectal cancer. The main questions it aims to answer are: 1. What are the risk factors for metastasis to the No.253 lymph node? 2.What is the prognosis for patients with metastasis to the No.253 lymph node? Patients with descending colon cancer, sigmoid colon cancer, and rectal cancer who undergo curative surgery with dissection of the No.253 lymph node are included in this study