Clinical Research Directory

Functional Lung Avoidance Planning Guided by Lung Perfusion PET/CT Versus Anatomical Planning for Lung Stereotactic Body Radiotherapy

Stereotactic body radiotherapy (SBRT) has an increasing role in the treatment of both primary and secondary lung tumors. However, lung SBRT remains associated with significant radiation induced lung injury (RILI). Indeed, the reported incidence of symptomatic radiation induced lung injury (grade≥2) in the published literature is up to 20%. A current challenge of lung SBRT is therefore to better preserve lung function and to reduce pulmonary toxicity. During standard lung SBRT planning, dose constraints are defined on the anatomical lung volume. This planning considers the lung as functionally uniform and does not take into account the variability of regional lung function distribution. Functional lung avoidance is an emerging concept in lung radiotherapy (RT). The technique aims at personalizing RT treatment planning to individuals' lung functional distribution, by sparing functional pulmonary areas while prioritizing delivery of high doses to non-functional regions. 68Ga-MAA lung perfusion PET/CT is a novel imaging modality for regional lung function assessment. As compared with conventional lung scintigraphy, lung perfusion PET/CT is inherently a vastly superior technology for image acquisition (higher sensitivity and spatial resolution, greater access to respiratory gated acquisition). A more accurate lung functional mapping improves the possibility of functional lung avoidance planning for SBRT. The hypothesis is that functional lung avoidance planning guided by 68Ga-MAA perfusion PET/CT, while delivering an optimal dose to the tumor, will reduce the frequency of RILI in patients treated with lung SBRT.

Impact of Lung Cancer Screening With Chest Scans Combined With Coaching on Smoking Cessation in Heavy Smokers

Lung cancer is common and serious, but when detected early, the chances of recovery are significantly better. Tobacco use is the leading cause. To help people break free from smoking, the Fribourg Cantonal Hospital (HFR), the Center for Tobacco Prevention (CIPRET), and the Fribourg Cancer League are joining forces in the STOP-LungCancer study (Smoking Termination Outcomes with Pulmonary Low Dose Computed Tomography for Lung Cancer Screening). What is the goal of this study? The investigators want to determine whether seeing and understanding images of the participants' own lungs helps participants quit smoking for good. Smoking cessation will be verified at 6 months using a breath test (measuring carbon monoxide), followed by a 2-year follow-up. How does participation work? The study is open to 116 residents of the canton of Fribourg aged 50 to 79 who are heavy smokers and motivated to quit. The program includes: 1. Personalized support: 4 smoking cessation coaching sessions organized by CIPRET. 2. Lung computed tomography (CT) scans: 3 exams spaced one year apart. This scan involves no needles or injections. The radiation dose is very low, about 0.6 millisieverts (mSv) per scan, and the associated risk is considered very low. 3. A review of the images with a doctor: During dedicated consultations, a thoracic radiologist reviews the participant's own computed tomography (CT) scans with the participant to explain the condition of the lungs and heart. What are the benefits? Participants receive both tailored support to quit smoking and close monitoring to detect any potential issues at a very early stage.

Robotic Bronchoscopy for Small Lung Nodules Without a Bronchus Sign

The goal of this observational study is to learn about the diagnostic performance and safety of robotic-assisted bronchoscopy using the Ion Endoluminal System in adults with small lung nodules that do not show a bronchus sign on CT imaging. The main questions it aims to answer are: * How effective is robotic-assisted bronchoscopy in obtaining a diagnosis for small lung nodules without a bronchus sign? * How safe is the procedure, including the risk of complications such as pneumothorax and bleeding? Participants who are already scheduled to undergo lung nodule biopsy using the Ion Endoluminal System and integrated mobile cone-beam CT (mCBCT) as part of their routine clinical care will be enrolled in this study.

Symptoms, Physical Function, and Recovery in Patients Receiving Lung Cancer Treatment Before Surgery

This study will examine how symptoms and physical abilities change during lung cancer treatment given before planned surgery, and how these changes relate to recovery after surgery. Treatment given before surgery is called neoadjuvant therapy. The main questions are: * How do symptoms and the ability to perform everyday activities change during treatment and before surgery? * Are symptoms and reduced physical function before surgery associated with lung complications or slower recovery afterward? * Can patient-reported information add useful information to routine preoperative assessment? Participants will complete questionnaires before starting neoadjuvant therapy, during treatment, before surgery, and during recovery after surgery. The questionnaires will assess symptoms such as fatigue, breathlessness, and pain, along with physical abilities and well-being. Researchers will also collect information from medical records about cancer treatment, lung function, anesthesia, surgery, pain management, and postoperative complications. Changes to the planned treatment pathway, including delays or cancellation of surgery, will be recorded. This is an observational study. Cancer treatment, surgery, and anesthesia will be determined by the treating clinical teams, not assigned by the research team. The findings may help identify patients who need additional assessment and support before and after lung surgery.

Risk-Based Lung Cancer Detection in COPD Patients

The goal of the interventional study is to evaluate whether risk-based stratification using the PLCOm2012 model and a machine learning (ML) model can identify patients with chronic obstructive pulmonary disease (COPD) who are at high risk of developing lung cancer and may benefit from low-dose computed tomography (LDCT) screening. The study population includes adults aged 50 years and older with COPD and a history of smoking attending an outpatient clinic. The main question it aims to answer are: \- What is the incidence of histopathologically confirmed lung cancer following risk-based stratification? Participants will: * Undergo lung cancer risk assessment using the PLCOm2012 model and an ML-based model based on clinical and laboratory data * Be referred for LDCT if classified as high-risk * Continue standard care if classified as low-risk * Be followed through electronic health records for up to six years to assess outcomes including lung cancer incidence, adherence to LDCT, time to imaging, healthcare utilization, costs, and safety

A Randomized Controlled Trial Comparing Percutaneous CT-Guided Biopsy and Shape-Sensing Robotic-Assisted Bronchoscopy

The ENCOMPASS study is a post-market, multicenter, randomized controlled trial comparing two established approaches for obtaining a biopsy of small pulmonary nodules (≤2 cm): CT-guided percutaneous lung nodule biopsy and shape-sensing robotic-assisted bronchoscopy with cone-beam CT (ssRAB with CBCT).

AI-Personalized Discharge Education for Patients After Lung Cancer Surgery

This randomized controlled trial evaluates the effect of artificial intelligence (AI)-personalized discharge education on discharge teaching quality and recovery outcomes in patients after lung cancer surgery. Eligible participants will be randomly assigned in a 1:1 ratio to either an intervention group or a control group. The control group will receive routine discharge education, including verbal instructions and a standardized printed discharge booklet. The intervention group will receive the same routine education plus an AI-generated personalized discharge guidance plan based on individual clinical and care-related information. All AI-generated content will be reviewed by a responsible nurse before being provided to participants. The primary outcome is the quality of discharge teaching measured on the day of discharge. Secondary outcomes include self-efficacy for postoperative rehabilitation management and quality of life assessed one month after discharge.

Accurate Planning and Guidance of Bronchoscopy for Lung Cancer Management

The main objective of this project is to demonstrate the potential of three new technical innovations for improving state-of-the-art bronchoscopy guidance systems. Through this study, we plan to generate preliminary data that demonstrates the potential of three new innovations for enhancing existing bronchoscopy systems in the live clinical setting. The goal is to demonstrate the potential of the new innovations: 1. to demonstrate the potential of a new methodology to reduce errors from CT-to-body divergence in the live clinical setting, 2. to demonstrate the potential of the new methodologies to enable live rerouting of a guided bronchoscopy, and 3. to perform automatic real-time mucosal lesion detection during a standard airway examination. These innovations could potentially improve current image-guided bronchoscopy systems and be used for future robotic bronchoscopy.

The Effects of Low Intensity Endurance Exercise on Improving Mitochondrial Function, Cell Bioelectrical Impedance Phase Angle, Fatigue and Quality of Life in Lung Cancer Patients With Cancer-related Fatigue

To conduct a randomized controlled trial (RCT) targeting lung cancer patients with cancer-related fatigue to achieve the following objectives: Objective 1: To investigate whether a low-intensity endurance exercise intervention can effectively improve mitochondrial DNA content, mitochondrial function, mitochondrial oxidative phosphorylation complex enzyme concentrations, cellular bioelectrical impedance phase angle, cancer-related fatigue, and quality of life in lung cancer patients with cancer-related fatigue. Objective 2: To explore whether the low-intensity endurance exercise intervention improves cancer-related fatigue and quality of life in lung cancer patients through direct or indirect effects by modulating mitochondrial DNA content, mitochondrial function, mitochondrial oxidative phosphorylation complex enzyme concentrations, and cellular bioelectrical impedance phase angle.

A Multicenter Prospective Study Evaluating the Diagnostic Performance of Femtosecond Laser Label-Free Imaging Combined With Artificial Intelligence for Predicting High-Risk Pathological Features in Lung Cancer

To investigate the diagnostic performance of Femtosecond Laser Label-Free Imaging combined with artificial intelligence for predicting high-risk pathological features in lung cancer

Registry of Minimally Invasive Cancer Treatment Using Spectral Angio-CT Image Guidance

This study collects data from patients undergoing minimally invasive, image-guided cancer treatments at participating hospitals in the Netherlands and France. All treatments are performed as standard clinical care and include procedures such as tumor ablation and catheter-based treatments of cancer in the liver, kidney, lung, and bone. During these procedures, a spectral angio-CT system is used for image guidance. This advanced CT scanner automatically captures additional imaging information beyond what is used in routine clinical decision-making. The goal of this study is to investigate how this additional imaging information is associated with treatment outcomes, and how it can be used in the future to improve treatment planning, procedural guidance, and prediction of treatment results. No experimental interventions are performed. Participation does not alter the treatment or follow-up patients receive. Data are collected from medical records and imaging systems and stored securely for analysis.

A Multicenter, Prospective Study on the Diagnostic Efficacy of Femtosecond Laser Label-Free Imaging Combined With Artificial Intelligence-Assisted Diagnosis for Rapid Diagnosis of Lung Cancer Surgical Specimens

To investigate the diagnostic efficacy of Femtosecond Laser Label-Free Imaging combined with artificial intelligence-assisted diagnosis for rapid diagnosis of lung cancer.

Effect of Mechanical Power-based Lung-protective Ventilation During One-lung Ventilation

The goal of this clinical trial is to determine whether a mechanical power-based lung-protective ventilation strategy during one-lung ventilation reduces the incidence of postoperative pulmonary complications in adult patients undergoing lung resection surgery. Mechanical power during pressure-regulated volume control mode is calculated using the formula below. Mechanical power (J/min) = 0.098 x respiratory rate x tidal volume x (inspiratory airway pressure above positive end-expiratory pressure + positive end-expiratory pressure) The main questions it aims to answer are: * Does a mechanical power-based lung-protective ventilation strategy significantly lower the incidence of major postoperative pulmonary complications compared to conventional ventilation? * How does this strategy impact intraoperative hemodynamic and vital profiles (e.g., blood pressure, cardiac output, vasopressor requirements, and blood oxygen saturation) during one-lung ventilation? Participants will: * Be randomized to receive either a mechanical power-based lung-protective ventilation strategy or a conventional lung-protective ventilation strategy exclusively during one-lung ventilation. * Be closely monitored for the occurrence of major postoperative pulmonary complications (atelectasis, pneumonia, acute respiratory distress syndrome, and pulmonary aspiration) and adverse events for 1 month postoperatively.

Combination Versus Alone Liposomal Bupivacaine Blocks in Minimally Invasive Thoracic Surgery-1

The goal of this clinical trial is to assess how the location of local anesthetic medication affects pain control capabilities in adult patients undergoing thoracic(chest)-only minimally invasive surgery. The main questions it aims to answer are: * Is pain decreased when local analgesia is provided as a combination of serratus anterior plane block and intercostal nerve block when compared to either block administered individually? * How does location of local analgesia administration impact length-of-stay, cost-of-care, and quality-of-life? Researchers will compare three treatment options including long-acting local anesthetic (Exparel®) administered as (1) intercostal nerve block, (2) serratus anterior plane block, or (3) combination of intercostal nerve block and serratus anterior plane block to see if pain and opioid use are reduced dependent upon treatment group. All participants will receive a local anesthetic nerve block. Participants will be asked to describe their pain after surgery and to answer various questionnaires before and after surgery.

Acupressure for Cough in Lung Cancer Survivors

The goal of this randomized controlled trial is to examine the effect of an acupressure intervention in alleviating cough and reducing co-occurring symptoms (dyspnea, cough, and fatigue) in patients with lung cancer. The hypotheses are: 1. Acupressure can alleviate cough in lung cancer survivors; 2. Acupressure can reduce a cough-related symptom cluster (dyspnea-cough-fatigue) experienced by lung cancer survivors; 3. Acupressure can reduce the symptom burden and improve the health-related quality of life and functional capacity of lung cancer survivors experiencing cough. Participants will: Receive acupressure for 8 weeks or receive an education booklet; Keep a diary of their acupressure practice and symptoms; Be assessed at baseline (T0), early intervention (T1), post-intervention (T2), and 8 weeks after the intervention period (T3).

A Stepped Intervention for Coping With Dyspnea in Patients With Lung Cancer-Phase A (Open Pilot)

Patients with lung cancer often experience shortness of breath, also known as dyspnea. It affects over 80% of patients with lung cancer at diagnosis and is linked to poorer quality of life and functioning. Unfortunately, current treatments-such as opioids, which are the most studied treatment for dyspnea-fail to provide patients with adequate care, and dyspnea can remain a chronic issue in many. Even when new treatments are developed, the benefit to public health is often limited by healthcare systems not having enough resources to use new treatments. The investigators' aim is to test a personalized treatment for dyspnea that can address patients' unique needs while efficiently using healthcare resources to make the treatment as accessible as possible for future widespread use. This project builds upon rhe investigators' prior work creating two promising psychological treatments for dyspnea. The first (a two-session behavioral treatment provided by nurses) targets dyspnea-related discomfort. The second (a five-session psychological treatment provided by psychologists) targets dyspnea-related anxiety and overall health outcomes. The investigators combined these complementary treatments with a stepped-care model into a treatment called INSPIRE. In INSPIRE, all patients will receive the brief treatment to learn basic behavioral coping skills to manage the discomfort of dyspnea before escalating to the more intensive treatment that focuses on providing patients with the confidence to cope with dyspnea and related anxiety, but only if patients' dyspnea does not improve after the first treatment. The investigators will first ask for initial feedback from patients who are receiving INSPIRE for dyspnea and the patients' study clinician to make sure the treatment and study procedures fit their needs. The investigators want to see if this approach can work in patients with lung cancer, is well-received, and shows early signs of improving dyspnea. The investigators' goal is to provide personalized relief for breathing difficulties while making the best use of healthcare resources. These findings will help the investigators learn more about how to support patients with dyspnea and provide information on how to further test INSPIRE. Additionally, this personalized supportive treatment for dyspnea may potentially help reduce the use of opioids currently used in the treatment of dyspnea.

Evaluate the Clinical Performance of the Flow Cytometry - FlowPath Lung Test as a Sensitive and Specific Non-invasive Diagnostic of Sputum Samples to Identify/Detect the Presence of Lung Cancer in High-risk Individuals Who Have Existing Lung Nodules, 6 to <30 mm in Diameter, Determined by LDCT.

Evaluate FlowPath Lung Diagnostic Test of Sputum Samples to Detect the Presence of Lung Cancer in High-risk Individuals Who Have Existing Lung Nodules, \>6 to \<30 mm in Diameter, Determined by LDCT.

Effect of Apneic Oxygenation of the Non-ventilated Lung During Lung Cancer Surgery.

This study investigates the effect of apneic oxygenation of the non-ventilated lung on local and systemic inflammatory response during lung cancer surgery. Patients undergoing surgical resection of lung cancer often require one-lung ventilation during anaesthesia. This results in alveolar hypoxia accompanied by upregulated expression of inflammatory markers. Apneic oxygenation of the non-ventiladed lung may influence inflammatory processes and oxygenation during surgery. The aim of this study is to evaluate whether apneic oxygenation affects inflammatory markers in lung tissue and postoperative recovery in patients undergoing lung cancer surgery. The study is conducted at a single center and includes adult patients scheduled for elective lung cancer surgery. Data will be collected durig the perioperative period. The results of this study may contribute to improved anaesthetic management and patient outcomes during thoracic surgery.

Smartphone-based Telerehabilitation Versus Home-based Inspiratory Muscle Training After Lung Resection in High-risk Patients

The goal of this pilot clinical trial is to assess the feasibility of smartphone-based telerehabilitation for inspiratory muscle training (IMT) and to explore its preliminary effects on postoperative recovery in high-risk adult patients after lung resection. Eligible participants are adults aged 19 years or older who underwent lung resection and met at least one high-risk criterion: preoperative forced expiratory volume in 1 second (FEV1) or diffusing capacity of the lung for carbon monoxide (DLCO) of 70% predicted or less, or age 65 years or older. The main questions it aims to answer are: Is smartphone-based telerehabilitation for IMT feasible and safe in this patient population? Does smartphone-based telerehabilitation for IMT show preliminary effects on functional exercise capacity, as measured by the 6-minute walk test (6MWT)? Researchers will compare smartphone-based telerehabilitation IMT with unsupervised home-based IMT to see whether remote supervision provides additional benefit after lung resection. Participants will: be randomized to either smartphone-based telerehabilitation IMT or unsupervised home-based IMT perform IMT 5 days per week for 6 weeks, starting at 20% of postoperative maximal inspiratory pressure (MIP) with progression according to tolerance complete outcome assessments at postoperative weeks 2-4, 8-10, and 14-16, including the 6MWT, pulmonary function tests (FVC, FEV1, MIP, and peak expiratory flow), handgrip strength, body composition, patient-reported outcomes, and cardiopulmonary exercise testing at final follow-up

A Study to Explore the Early Subjective Evaluation and Objective Recovery in Lung Cancer Patients Undergoing Sublobar Resection Versus Lobectomy

The trial was designed as a single-center, non-interventional, prospective observational study to explore the role of a multimodal digital device in analyzing subjective and objective recovery in lung cancer patients undergoing sublobar resection versus lobectomy.

Investigation of the Effects of Tele-Yoga Training in Individuals With Lung Cancer Undergoing Lung Resection Surgery

This randomized controlled clinical trial aims to evaluate the effects of an 8-week tele-yoga intervention in individuals with lung cancer who have undergone lung resection surgery. The intervention group will receive supervised yoga sessions via online synchronous video conferencing, while the control group will continue with standard post-operative care. The primary outcome is exercise capacity (6-minute walk test), with secondary outcomes including pulmonary function, respiratory and peripheral muscle strength, physical activity level, dyspnea, fatigue, sleep quality, anxiety and depression, and quality of life. It is hypothesized that tele-yoga will improve physical and psychological recovery post-surgery and may serve as a feasible home-based pulmonary rehabilitation alternative.

Blood Based Risk Evaluation With AI for Targeted Primary Health Care in Early Lung Cancer Detection

The study is a prospective, non-randomized feasibility study evaluating blood sample and machine learning-based risk stratification for lung cancer in patients with COPD (chronic obstructive pulmonary disease). Patients with COPD will be recruited in general practice, where they will have a blood sample drawn. All data will be analyzed by the machine learning model, and patients with increased risk of lung cancer will be referred for a low-dose CT scan of the chest. The primary objective of the study is to evaluate the feasibility of AI and DNA methylation-based risk stratification for lung cancer in patients with COPD in a primary care setting. The secondary objectives are to evaluate the safety of the risk stratification approach, the potential effects on quality of life and wellbeing, to gain insight into the patient and physician perspectives, and to estimate the health economic consequences.

Telehealth Collaborative Care Model (CoCM) in Lung Cancer

The goal of this trial is to compare the impact of two outreach strategies (high touch vs. standard outreach) on a collaborative care program delivered via telehealth to patients with lung cancer.

Promoting Radon Testing Among Mothers of Young Children

Radon is the second-leading cause of lung cancer after smoking and may contribute to other cancer deaths; children are especially vulnerable due to a larger lung surface area and higher respiratory rates. The goal of this research is to test the feasibility of the radon app to promote radon testing among mothers of children aged 4 or younger when they receive a free radon test kit.