Clinical Research Directory

Erector Spinae Versus Intercostal Nerve Blocks With Liposomal Bupivacaine for Analgesia in Thoracic Surgery

This clinical trial compares efficacy in postoperative pain management in thoracic surgery between erector spinae block versus liposomal bupivacaine injections.

Rapid Autopsy and Procurement of Cancer Tissue

Background: \- Individuals with cancer of the lung, chest cavity, ovary, or bladder, as well as patients who have been treated with adoptive cell therapy unfortunately commonly succumb to their disease. Some agree to donate their bodies to cancer research that may help the medical community better understand these diseases. Studies of cancer tumor tissue obtained soon after death may be used to answer questions about the origins, progression, and treatment of cancer. Researchers want to conduct a study that involves planned collection of cancer tumor tissue shortly after death. To do so, they will arrange to provide inpatient hospice care for people with lung cancer, ovarian cancer, bladder cancer, or patients who have been treated with adoptive cell therapy. \<TAB\> Objectives: \- To collect cancer tissue biopsy samples as soon as possible after death. Eligibility: \- Individuals who have cancer of the lung, chest cavity, ovary, or bladder, or those who have been treated with adoptive cell therapy and are planning to receive end-of-life hospice care are eligible to participate. Design: * Participants will agree to receive inpatient hospice care at the National Institutes of Health Clinical Center. Full details on end-of-life care preference will be acknowledged. * An autopsy will be performed at the clinical center within 3 hours of death. Tumor tissue will be collected from the primary site of cancer and from any areas of the body to which the cancer has spread. * Participants will not receive further cancer treatments as part of this study. This is a tissue collection study only.

Early Phase Study of KESONOTIDE™in Participants With Solid Tumours

This clinical trial is an adaptive study of a novel vimentin inhibitor in cancers. It is an open label, multicentre, single ascending dose level in phase I and cohort exploration in phase II. Primary objective is to evaluate safety and tolerability of KESONOTIDE™ as a monotherapy in participants with advanced/metastatic solid cancers. Secondary objective is to characterise the pharmacokinetics of KESONOTIDE™. Phase I study will enrol 20-32 participants and Phase II approximately 80 participants.

General Anesthesia vs Conscious Sedation for Radial Endobronchial Ultrasound

The endoscopic investigation of lung lesions is experiencing significant growth with the increasing number of lung cancer screening programs. Peripheral endobronchial ultrasound (pEBUS) is the most widely used endoscopic technique in the investigation of peripheral pulmonary lesions (PPL). It is performed in relatively equal proportions under conscious sedation and general anesthesia by interventional pulmonologists throughout the world. Users of conscious sedation justify themselves by the fewer resources consumed and the absence of demonstration of a superior diagnostic yield of general anesthesia while users of general anesthesia claim diagnostic yield and comfort for the patient are superior with their approach. Our main objective is to compare the diagnostic yield of pEBUS under general anesthesia to that obtained under conscious sedation.

Extended Reality (XR)-Assisted CT Localization of Pulmonary Nodules

Extended Reality (XR)-Assisted CT Localization of Pulmonary Nodules

Precision Lung Cancer Survivorship Care Intervention

The overarching goal of the Kentucky LEADS Collaborative Lung Cancer Survivorship Care program is to reduce the burden of lung cancer by offering an innovative survivorship care approach that improves lung cancer quality of life, overcomes lung cancer stigma, and helps survivors engage with care. The project involves a two-group parallel randomized clinical trial comparing the impact of the Kentucky LEADS Collaborative Lung Cancer Survivorship Care program (KLCLCSC) among lung cancer survivors (N=300) against an enhanced usual care condition (bibliotherapy+assessment) on quality of life outcomes.

AVENTINE-1: Study of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (AVZO-1418-1001)

This study, the first clinical trial of AVZO-1418, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of AVZO-1418 when administered intravenously as a monotherapy and potentially in combination therapy to patients with locally advanced or metastatic epithelial solid tumors.

Shape-Sensing Robotic-Assisted Bronchoscopy for Diagnosis of Peripheral Pulmonary Nodules in Korea

What is this study about? This study tests a new robotic technology to take tissue samples from lung nodules (small spots in the lungs). Some lung nodules are cancer, but doctors need a tissue sample to know for sure. What is the problem? Current methods to get tissue from lung nodules only work about 7 out of 10 times. When they don't work, doctors may need riskier procedures. What is the new technology? The new technology is called robotic bronchoscopy (ssRAB). It uses a robot with special sensors to guide a thin tube more accurately to lung nodules than current methods. Who can join? Adults aged 19 or older who have lung nodules that need tissue sampling and are healthy enough for the procedure. What happens? Participants will have the robotic procedure while asleep under anesthesia. The robot guides a thin tube to the lung nodule to take a small tissue sample. Participants are watched for problems and followed for 6 months. What are the risks and benefits? The new technology may be more accurate and safer than current methods. The main risks are small chance of lung collapse or bleeding, similar to regular procedures. Why is this important? This study will show if the new robotic technology works well and is safe in Korea. If successful, it could help diagnose lung cancer earlier and more accurately. This study will include 100 people at Ulsan University Hospital in Korea.

An Evaluation of Dose-escalation for Intrathoracic Tumours

This is a pragmatic trial with patients randomized between standard of care palliative thoracic radiation therapy (RT) vs. hypofractionated, dose-escalated, esophageal-sparing (HD-ES) intensity modulated radiation therapy (IMRT). The investigators hypothesize that the use of advanced radiation planning techniques to optimize dose to esophagus will permit the safe delivery of a modestly dose-escalated five-fraction course of palliative radiation to intrathoracic malignancies. This approach aims to deliver higher biologically effective doses while improving toxicity when compared to conventional approaches with the goal of prolonging high-quality overall survival.

A Study on the Improvement of Postoperative Symptoms and Survival Benefits of Modified Bufei Decoction in Elderly Patients With Lung Cancer Undergoing Radical Surgery

This is a randomized double-blind placebo-controlled phase II clinical study that included patients with symptoms such as cough, shortness of breath, and fatigue after lung cancer resection surgery. They were given orally modified Bufei Tang granules twice a day for 28 days, with one packet taken orally with water. Using the MDASI-TCM symptom scoring system, evaluate the scores of symptoms such as cough, shortness of breath, and fatigue before and after the experiment, and calculate the difference in scores between the control group and the experimental group before and after the experiment.

A Single Dose, Open-Label, Dose-escalation Study of the Safety and Imaging Characteristics of LS301-IT for Intraoperative Imaging of Lung Cancer

The aim of this Phase 1b study is to investigate the safety and fluorescence signal of a single dose of LS301-IT, a novel fluorescence imaging agent developed by Integro Theranostics (IT), administered by slow intravenous (IV) administration in patients undergoing surgical thoracoscopy and resection of lung cancer. Safety is the primary objective of this study, followed by the evaluation of the fluorescence signal as it relates to dose level and dosing time interval.

Sustainable Implementation of the EXCEL Exercise Oncology Program Across Canada

EXCEL will provide online and, where feasible, in-person exercise programs to individuals living with and beyond cancer (ILWBC). Research has shown that targeted programs that include tailored exercise prescriptions are more successful in helping individuals with chronic disease to incorporate physical activity and exercise into their daily routines. While ILWBC are advised by healthcare professionals (HCPs) to engage in exercise, there is a lack of cancer-specific exercise programs and cancer-trained exercise specialists in Canada, outside of the research setting. Considering the negative impact cancer and its treatments have on fitness and physical activity levels, community-based efforts towards improving access, uptake and maintenance of exercise programming are needed. This study will evaluate the benefits of a community-based or online EXCEL exercise program for people living with and beyond cancer across Canada, using a streamlined intake process compared to the original EXCEL Study (HREBA.CC-20-0098, NCT04478851). This 8 to 12-week program (intervention) will be delivered in-person or over virtual platform. It includes twice weekly supervised exercise classes.

An Open-label, Phase I Clinical Trial of Super1 TCR-T in NY-ESO-1-positive Patients With Advanced Solid Tumors

This study was a phase I safety and tolerability clinical trial conducted in a single-center, open-label, 3+3 design with dose escalation.

Acupuncture Combined With PD-1/PD-L1 Inhibitors for Advanced Lung Cancer

This study will be an evaluation of the efficacy and safety of acupuncture to enhance the response rate of immunotherapy in advanced lung cancer. The main questions it aims to answer are 1. Does acupuncture heighten the response rate of immunotherapy in advanced lung cancer? 2. Does acupuncture heighten the safety of immunotherapy in advanced lung cancer? Researchers will compare acupuncture to sham acupuncture to see if acupuncture could enhance the response rate of immunotherapy in advanced lung cancer. Both groups will receive a standard anti-tumor Western medical treatment regimen (PD-1/PD-L1 inhibitor combined with chemotherapy), and the experimental and control groups will be treated with 4 cycles of acupuncture or sham-acupuncture on top of the anti-tumor treatment regimen, respectively. Patients were followed up every three weeks for the first three months and every three months thereafter to record any disease progression, adverse events, survival or mortality status, and so on.

Bright Light Therapy on Sleep Health in Lung Cancer Patients

The goal of this randomized intervention trial is to determine the effect of bright light therapy on sleep disturbance, as well as to investigate the impacts of bright light therapy on biological age measured by clinical biomarkers. The main questions it aims to answer are: * Does bright light therapy improve sleep patterns (i.e., sleep onset latency, sleep disturbance, and sleep efficiency) in lung cancer patients? * Can bright light therapy slow the rate of aging measured by biological age in lung cancer patients? Researchers will compare bright light therapy group to control group to see if bright light works to reduce sleep disturbance and decelerate biological aging. Participants will: * Receive bright light exposure or usual light exposure every day for 4 weeks * Get blood draw at the baseline and at 4 weeks for clinical biomarkers tests * Complete self-reported sleep, fatigue and stress surveys at the baseline and at 4 weeks * Keep a daily sleep log

Assessment the Effectiveness of BTVA in COPD and Ablation in Pulmonary Nodules by Pulmonary MRI

A Clinical Study Based on Magnetic Resonance Imaging of the Lungs to Assess the Efficacy of Thermal Vapor Ablation and Pulmonary Nodule Ablation in Chronic Obstructive Pulmonary Disease After Surgery. The efficacy of hot steam ablation for chronic obstructive pulmonary disease was evaluated using the innovative MRI sequence PREFUL\_MRI, and the efficacy of pulmonary nodule ablation was evaluated using the innovative MRI sequence GRASP\_MRI.

Spatial Fragmentation Combined With Low-dose Radiotherapy for Immunotherapy Combined With Chemotherapy-resistant Locally Advanced or Advanced Non-small Cell Lung Cancer

The purpose of this study was to evaluate the effect of immunotherapy combined with spatial fractionation radiotherapy and low dose radiotherapy on the prognosis of patients with advanced lung cancer under specific dose regimens (spatial fractionation radiotherapy: high dose region: 800-1200cGy × 3f, low dose region: 100-300cGy × 5f; low dose radiotherapy area: 100-300cGy × 5f). Through the phase II clinical trial, to determine the efficacy and safety of the combined treatment model in advanced lung cancer and its effect on the immune microenvironment of patients, so as to provide scientific basis for the optimization of treatment regimen for advanced lung cancer.

⁶⁸Ga-DPA in the Lung Cancer Diagnosis

In previous studies, we synthesized a PD-L1-targeted molecular probe, ⁶⁸Ga-DPA, and developed a ⁶⁸Ga-DPA injection for clinical research. Preliminary studies demonstrated its favorable safety profile and excellent imaging performance. Leveraging the established strengths of the Department of Nuclear Medicine at Peking Union Medical College Hospital, we now plan to conduct an exploratory PET/CT imaging study in lung cancer patients. This study aims to provide an in vivo, non-invasive, and visualizable technique for detecting PD-L1 expression levels and spatial distribution in tumors. It will further validate the clinical utility of this technology, offering critical diagnostic insights for initial assessment and treatment efficacy evaluation in PD-L1-positive tumor patients undergoing PD-L1-targeted therapies.

Application of Extended Reality (XR)-Assisted CT-Guided Localization of Pulmonary Nodules in Thoracoscopic Sublobar Resection.

Reality (XR)-Assisted CT-Guided Localization

18F Labeled FAP Targeted Molecular Probe in Early Tumor Diagnosis

Evaluate the safety of the novel FAP targeted molecular probe 18F-FAPI-YQ104 labeled with radioactive isotopes in clinical applications and verify its effectiveness in tumor diagnosis.

Quality of Life as a Predictor of OS and PFS in Patients With Lung Cancer

By 2020, lung cancer continues leading the first cause of cancer mortality and the second most common type of cancer in the world. There are limitations to early detection and then more than 60% of patients are diagnosed in advanced stages where there are no longer curative options; that situation is associated with high mortality and poor survival. It is known that some clinical and biochemical parameters of the disease have been recognized as prognostic factors; however, it has been described that a reduction in the overall global quality of life score, mainly by physical function, increased pain, and dysphagia, are associated with mortality, and having high social well-being and global quality of life scores are associated with a lower risk of death. Objective: This study will measure association between Health-Related Quality of Life levels and mortality and progression free survival in advanced non-small cell lung cancer patients Patients and methods: This study will include patients with lung cancer histopathological confirmed including bronchus or trachea. Methodologically, the study has two components: One related to the exposure variable (HRQL), which involves a scale validation study, and other related to the measurement of the association between HRQoL and survival outcomes, which involves a prospective cohort analytical observational study. This last component will be carried out specifically with a sample of patients with non-small cell lung cancer (NSCLC). Results and impact: The project contribute to the implementation of tools adapted and validated in the Colombian context to assess the quality of life in patients with lung cancer. Additionally, knowing the relationship between quality of life and traditional oncological outcomes will provide tools to give patients with comprehensive treatment, and to have a prognosis of the disease that incorporates psychosocial aspects

Analysis of Circulating Tumor Markers in Blood

The circulating tumoral biomarkers in the blood are the object of numerous researches for several decades. The potential clinical interests of these circulating biomarkers are diagnostic, prognostic, predictive of the efficiency of targeted therapies (according to the mutational profile of the cancer), and could allow the study of the mechanisms of resistance under process. In the multiplicity of these blood potential biomarkers joins a permanent evolution of the technological means used to detect them/to quantify, as well as to estimate their clinical utility.

SERS-Based Serum Molecular Spectral Screening for Hematogenous Metastasis

Although modern medicine has made significant progress in the diagnosis and treatment of lung cancer, most patients are diagnosed at locally advanced stage or with distant metastases, especially in the late stages where the cancer has spread to other organs through hematogenous metastasis. This not only significantly the survival rate of patients but also increases the complexity and difficulty of treatment. Hematogenous metastasis plays an important role in the clinical progression of lung cancer, its complex biological processes pose a huge challenge for clinical management. Early detection of hematogenous metastasis is difficult, and traditional imaging methods have limited sensitivity in detecting small metastatic lesions. The emerging technology of circulating tumor cells (CTCs) has been limited in clinical application due to its high detection costs and technical requirements. Therefore researching and developing high-sensitivity, high-specificity, simple, easy-to-popularize, and low-cost technologies to predict the risk of hematogenous metastasis lung cancer is crucial for early diagnosis and more precise treatment. Raman spectroscopy (RS), a non-invasive and highly specific molecular detection technology, can detect in biomolecules such as proteins, nucleic acids, lipids, and sugars related to tumor metabolism in biological samples at the molecular level. Surface-enhanced R spectroscopy (SERS), developed based on this technology, is one of the feasible methods for high-sensitivity biomolecular analysis. Although SERS technology has shown diagnostic results in numerous preclinical studies of various tumors, it is limited by small sample sizes and lacks external validation. Therefore, clinical studies on the diagnosis of tumors Raman spectroscopy are needed, with the following requirements: 1. Objective, rapid, and practical Raman spectroscopy data processing methods are needed, and and deep learning methods may be the best classification methods; 2. Multicenter, large-sample clinical samples are needed to train deep learning diagnostic models, and real-world performance should be validated through external data from prospective studies. In previous study, the investigators collected serum Raman spectroscopy data from a cohort of 23 patients with lung malignancies and developed an intelligent Raman diagnostic system for hematogenous metastasis in non-small cell lung cancer (NSCLC) based on learning models, with an accuracy rate of 95%. To obtain the highest level of clinical evidence and truly achieve clinical translation, this prospective, multicenter clinical aims to validate the use of this intelligent diagnostic system for early diagnosis of hematogenous metastasis in NSCLC.

EMPOWER-1: A Multi-site Clinical Cohort Research Study to Reduce Health Inequality

Health inequality and genetic disparity are a significant issue in the United Kingdom (UK). This study focuses on diseases that are associated with significant morbidity and mortality in the UK, and specifically examines the extent and basis of treatment failure in different patient populations. The vast majority of drug registration clinical trials have under-representation of ethnic minority populations. In addition, the wider Caucasian populations have reasonably different clinical characteristics to the population that participated in the drug licencing clinical trials. A consequence of this is that drugs are licensed for use in real-world general patient populations where the clinical trial results are simply not statistically significant to specifically demonstrate efficacy or safety in populations that were either absent or under-represented in the drug registration clinical trials. When these facts are considered alongside data that supports significant under-reporting of adverse events in the real-world setting within the UK (and globally, e.g the USA and Europe), it highlights that pharmacovigilance systems are unable to capture drug effectiveness and safety data in a manner that can reasonably assure appropriate prescribing in the wider patient populations. This large real-world research study aims to identify whether commonly prescribed drugs are effective in treating illnesses that cause significant poor health and death in the different patient populations that represent the UK. The goal of this study is to generate large quantitative data-sets that may inform clinical practice to reduce the existing health inequality and genetic disparity in the UK.