Active clinical trials for "Thoracic Neoplasms"

DCE-CT of thoracic tumors as an early biomarker for treatment monitoring in comparison with morphologic criteria. Rationale of the clinical investigation For the evaluation of response to anti-tumoral therapy in thoracic tumors, merely morphologic information is often not sufficient for early response evaluation as dimensions of the oncologic lesions are not changing during the first weeks of treatment. To be able to measure functional changes, dynamic contrast-enhanced CT (DCE-CT) seems promising as a biomarker for early therapy monitoring. Having an early biomarker for treatment monitoring will allow to increase patients' prognosis if a non-responder is earlier detected, will optimize the use of expensive treatments, is expected to shorten hospitalization and shorten absence at work, and to decrease side-effects of (adjuvant) medication. Objective of the study 2.1.Primary objectives The primary objective is to investigate the potential of functional imaging (i.e. DCE-CT), as analyzed by the Hyperfusion analytic software, as an early biomarker for the evaluation of therapy response in primary thoracic malignancy. 2.2.Secondary objectives There are two secondary objectives: To define internal system parameters and perfusion parameter thresholds that maximize the accuracy of the outcomes and to define the correct category (PD, SD, PR, CR); and To compare the predicted categorization to the assessed RECIST1.1 categorization. Endpoints 3.1.Primary Endpoint The primary endpoint is to directly compare the biomarker of the HF analysis software at week 3 (+- 1 week) and week 8 (+- 3 weeks) with the eventually reported Progression-Free Survival (PFS) intervals and Overall Survival (OS) in this study. PFS intervals are determined by the clinician and are based on RECIST1.1 and additional clinical and biochemical progression markers. The focus will be on evaluating the accuracy of the prediction as well as how early the prediction was correct. 3.2.Secondary Endpoints There are two secondary endpoints corresponding to the two secondary objectives. The internal parameters for the HF biomarker, e.g. magnitude of the Ktrans decrease, and the change in volume of unhealthy tissue, need to be determined to define the classification (PD, SD, PR and CR) by the HF analysis software. These parameters are optimized to optimally predict the classification according to PFS and OS. This will be done by splitting the data into a train and test set to ensure generalization. The classification of the HF analysis software will be compared to the purely morphological classification by RECIST1.1 to identify correlation. Furthermore, some cases will be investigated where the HF analysis performs noticeably better or worse than RECIST1.1 in predicting PFS and OS. Finally, the difference in time to the first correct prediction is compared between HF and RECIST1.1. 4.Study Design This prospective study is part of the clinical β-phase. We aim to test pre-release versions of the Hyperfusion.ai software under real-world working conditions in a hospital (clinical) setting. It is important to note, though, that the results of the software analysis will not be used by interpreting physicians to alter clinical judgement during the course of the clinical trial. A prospective study including 100 inoperable patients in UZ Gent suffering from primary thoracic malignancy (≥15mm diameter) will be conducted. For this study, in total 3 CT scan examinations of the thorax will be performed (a venous CT examination of the thorax in combination with a DCE-CT scan of the tumoral region). All patients will be recruited from the pulmonology department. Oncologic patients are clinically referred with certain intervals for a clinically indicated CT scan (being part of standard care). In the study, two clinical CT examinations that are performed standard of care (baseline CT examination and CT examination at week 8 (+- 3 weeks) after start of systemic therapy) will be executed by also adding a DCE-image of the lung adenocarcinoma to this examination. This DCE-image is performed during the waiting time before the venous/morphologic phase. Consequently, from a clinical point-of-view, the time to scan remains exactly the same. With regard to the contrast agent, an identical amount is injected as is the case in standard of care, but the contrast bolus is split in two parts - see also addendum with DCE protocol. In this study there is one additional CT-examination (DCE-scan of the thoracic malignancy in combination with venous CT scan of the thorax) at week 3 (± 1 week).

Lung cancer is the second most common cancer in the UK with around 43,500 new patients diagnosed each year. About 69% of patients are diagnosed with advanced stage disease and at present these patients would be expected to survive for less than 12 months. These statistics therefore show the need for the development of new effective drugs in the treatment of advanced Lung cancer. Recent trial results have shown the efficacy of immunotherapy in treating several types of tumours including lung cancer. These tumours are known to express a high level of a glycoprotein called PDL1 which is a component of the PD1 pathway. In cancer the PD1 pathway can be hijacked by tumours leading to the immune system being suppressed. The aim of the new drug Pembrolizumab is to restart the PD1 pathway and use the immune system to help fight the cancer cells. Radiotherapy has also been shown to cause cancer to increase production of the proteins that can block the immune system. Therefore it has been proposed that combine of new immunotherapy agent such as pembrolizumab and radiotherapy in the treatment of lung cancer will allow more cancer cells to be killed through the immune system. The purpose of this study is to see if pembrolizumab can safety be combined with standard palliative radiotherapy in patients with lung cancer. In addition once the patients have completed their course of radiotherapy they will remain on pembrolizumab alone and the study will look at how well this treatment regimen can control the growth of the cancer.

The overall, broad objective of this study is to pilot the BSD technique. The specific purpose of this particular study is to generate pilot data to validate several crucial steps of the BSD technique, in particular steps 1, 2, and 4. Radiation treatments will proceed per standard of care, and will not be modified in any way during this protocol. This study is a non-treatment protocol.

Evaluation of post-operative respiratory complications after thoracic surgery for pulmonary resection in patients with COPD Introduction: Postoperative pulmonary complications following pulmonary resection occur in 12-40% of cases. Some risk factors such as COPD are well identified. It has been shown that COPD patients with a history of frequent exacerbations are more likely to develop exacerbations. No study has evaluated the rate of patients called 'frequent exacerbators' among COPD patients requiring pulmonary resection and the relations between exacerbations history and incidence of acute respiratory postoperative complications. The main objective is to determine the frequency of pulmonary postoperative complications (atelectasis, acute respiratory failure, pneumonia) following lung resection in COPD patients. The secondary objectives are to determine the frequency of extra pulmonary postoperative complications and the prevalence of the 'frequent exacerbator' phenotype in this population, as well as its relation with the risk of post-operative complications. Materials and Methods: This is a prospective, observational, single-center study, of patients with COPD hospitalized for elective thoracic surgery in the center of Thoracic Surgery, Hôpital Cochin. The inclusion criteria are: male or female aged more than 40 years, permanent airflow obstruction as defined by an FEV/FVC ratio < 70% after bronchodilator. Collected data will be: COPD symptoms (dyspnea score, exacerbations) by a questionnaire given to the patient during the anesthesia consultation, COPD severity scores, comorbidities, per operative data, postoperative complications, hospitalization and intra-hospital mortality. Perspectives: This work will provide information on the risk of postoperative complications in patients with COPD and the influence of the 'frequent exacerbator' phenotype. This will help adapting preventive care to the COPD subtype .

L-[3-18F]-α-methyltyrosine (18F-FMT) is an amino-acid tracer for positron emission tomography (PET). The aim of this study was to determine whether PET-CT with 18F-FMT provides additional information for the preoperative diagnostic workup as compared with 18F-FDG PET. Tumor uptake of 18F-FMT was compared with several immunohistochemical markers including L-type amino acid transporter 1 (LAT1).

Mediastinal neurogenic tumors are relatively rare in children. Surgical resection is essential. Minimal invasive surgery is more and more used in pediatric population, but his evaluation for resection of thoracic neurogenic tumors is little studied. Thoracotomy has specific long terms post operative complications. When compared to thoracotomy, thoracoscopy shows less operative blood loss, shorter duration of chest tube ans length of stay. Recently, the indications of thoracoscopic approach have been assessed according to the presence or absence of image-defined risk factors (IDRF) at diagnosis and after preoperative chemotherapy in a monocentric retrospective study. The investigators aimed to conduct a multicentric retrospective study to assess the role of thoracoscopy in neurogenic thoracic tumours according to the presence or absence of IDRF at diagnosis, the surgical complications and outcome.

Controlling hypothermia is essential in anesthesia to limit postoperative complications. Temperature monitoring is therefore essential. However, the reliability of esophageal temperature during open chest lung surgery is discussed and not accurately assessed in the literature.

Our goal is to develop a reliable, physician and patient-friendly, pre-operative Thoracic Onco-Geriatric Assessment (TOGA) to predict surgical risk in geriatric oncology patients with thoracic neoplasms of the lung, esophagus, pleura and thymus, modeled upon existing CGA tools, including the Preoperative Assessment of Cancer in the Elderly (PACE)

SPECTAlung is a program aiming at screening patients with thoracic tumors to identify the molecular characteristics of their disease. The thoracic tumors include lung cancer, malignant pleural mesothelioma, thymoma or thymic carcinoma at any stage. Once the molecular characteristics are identified, there might be the possibility to offer these patients access to targeted clinical trials.

The goal of this multicentric French randomized trial is to determine the best auto fluorescence bronchial endoscopic follow-up strategy in high risk patients bearing low grade bronchial precancerous lesions. Subjects will be randomly assigned to one of the following arm : (A) every 6 months clinical and chest Xrays follow-up without intermediate endoscopy, (B) every 6 months clinical and chest Xrays follow-up including repeated autofluorescence endoscopy and biopsies on a 6 months basis in case of low grade dysplasia or on a one year basis in patients without dysplasia. After 36 months follow-up, each patient from the two groups will be subjected to a final autofluorescence endoscopy and biopsy and a Spiral Chest Xray. The final analysis will compare between the two groups : The probability of progression from an initially identified low grade lesion to a high grade lesion The probability of respiratory epithelial tract progression assessed by the occurrence of a lung cancer or high grade lesion. The characteristics of lung cancers detected in each arm In both arm, the influence of risk factors and persistent exposure to tobacco on lesion evolutivity.