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Lung Neoplasms clinical trials

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NCT ID: NCT05545085 Recruiting - Pulmonary Cancer Clinical Trials

Thoracoscopic Laser Speckle Contrast Imaging for Segment Resections

PORTION-I
Start date: November 1, 2022
Phase:
Study type: Observational [Patient Registry]

Rationale Lung cancer remains to be the leading cause of cancer-related deaths worldwide1. The current standard-of-care for small lung cancer is a total lobectomy. Albeit effective with respect to the radical excision of the tumour, the substantial loss in lung tissue may be clinically relevant, especially in combination with frequently co-existing lung diseases. Thoracoscopic segmentectomy is a combination of adequate oncological resection with lung-tissue-sparing properties and is being increasingly used because of its several advantages compared with lobar resections. By defining the segment that has to be excised pre-operatively, the key to successful pulmonary segmentectomy is to subsequently intraoperatively recognize the intersegmental planes correctly. The conventional and most common method uses a ventilation method (inflation/deflation technique). With the increasing availability of endoscopic imaging systems, indocyanine green (ICG) fluorescence imaging is a more advanced method to determine intersegmental planes. The major limitation is the use of an exogenous contrast agent. After injection, the ICG only has very limited "imaging time window" (minutes) in which the images can be used to determine the intersegmental planes. Furthermore, the use of dye limits repeatability of measurements due to rest ICG, the extra operating room time required for the injection, wash-in and wash-out of the dye as well as change of camera settings. These limitations leave room for new technologies and improvements. The investigators hypothesized that an endoscopic laser speckle imaging device could overcome the limitations of ICG-fluorescence imaging and could thus be a very useful addition in intersegmental plane detection. PerfusiX-Imaging (LIMIS Development BV, Leeuwarden, The Netherlands) is such an endoscopic laser speckle contrast imager that has been developed in the Medical Centre Leeuwarden since 2014. LSCI has never been used to identify intersegmental planes, however, based on the similarities between LSCI and ICG-fluorescence, this novel imaging approach is thought to be effective and potentially could be used as a standard-of-care. Objectives In this trial the investigators will study the utility of PerfusiX-Imaging for the identification of intersegmental planes during thoracoscopic segmentectomy. Study design The current study is a prospective, observational single-centre study in the Medical Center Leeuwarden. Study population A total of 10 patients undergoing an upper left or right lobectomy. Patient related study procedures All patients will undergo the standard-of-care program which includes perfusion assessment by ICG-fluorescence imaging. In addition to this standard-of-care, 2D-perfusion maps will be generated from images taken with PerfusiX-Imaging (LIMIS Development BV, Leeuwarden, The Netherlands). Not related to the patient, the PerfusiX-Imaging images will be shown to the surgeon postoperatively and peroperative questionnaires will be filled regarding the standard-of-care perfusion assessment. Study parameters/endpoints Due to the explorative character of this study, there is no formal hierarchy in the respective endpoints of this study. In this, all endpoints will add to the overall assessment of the feasibility of the PerfusiX-imaging derived visual feedback for detecting interlobar and intersegmental planes in lung tissue. The investigators will register whether it was possible to detect the intersegmental plane. Subsequently, compare the difference in location of both the interlobar and intersegmental planes as derived from visual feedback from the PerfusiX-imaging system is compared, with images derived from ICG imaging and the surgical eye. During the procedure, the time needed to generate and acquire the visual feedback from the PerfusiX-imaging system will be determined. The investigators will also determine the interpretability of the visual feedback from the PerfusiX-imaging system by users (surgeons). In addition, the investigators will determine Laser Speckle Perfusion Unit (LSPU) cut-off values of PerfusiX-imaging in lung tissue with the best sensitivity and specificity for the indication of level of tissue perfusion. Burden, risk and benefit to participation Burden Not applicable. Risks Not applicable. Benefit Not applicable.

NCT ID: NCT05543954 Recruiting - Lung Neoplasms Clinical Trials

68Ga-FAPI-RGD PET/CT Imaging in the Lung Cancer Patients

Start date: September 3, 2022
Phase: Early Phase 1
Study type: Interventional

Based on the high expression of specific receptors on the surface of diseased tissues and neovascularization, noninvasive targeted molecular imaging can be used to visualize lesions in vitro by combining specific ligands labeled with short half-life isotopes. Lung cancer tissues express fibroblast activating protein FAP, and also have high expression of integrin αVβ3 receptor on the surface of blood vessels. In this study, a novel dual-target imaging agent 68Ga-FAPI-RGD was used for PET/CT imaging of lung cancer.

NCT ID: NCT05543629 Active, not recruiting - Clinical trials for Non-small Cell Lung Cancer

A Study of BMS-986442 With Nivolumab With or Without Chemotherapy in Solid Tumors and Non-small Cell Lung Cancer

Start date: October 4, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate BMS-986442 in combination with nivolumab (with or without chemotherapy) for its antitumor efficacy and benefit to participants.

NCT ID: NCT05542485 Recruiting - Clinical trials for Non-small Cell Lung Cancer

PLAsma Genomic Testing in Patients With Advanced Non-Small Cell Lung Cancer: The PLAN Study

PLAN
Start date: August 6, 2023
Phase:
Study type: Observational

This is a multi-centre, prospective, translational study investigating the use of plasma genotyping for initial genomic testing in newly diagnosed advanced/locally advanced non-squamous NSCLC. In this study, patients will have a plasma genotyping assay completed following confirmation of suspected diagnosis of non-squamous NSCLC at institutional Rapid Access Lung Cancer Clinics (RALCC), alongside standard tissue-based biopsy and genotyping.

NCT ID: NCT05541744 Not yet recruiting - Lung Cancer Clinical Trials

The Use of Molecular Radiogenomics in Non-small Cell Lung Cancer

NSCLC
Start date: August 1, 2023
Phase:
Study type: Observational

Lung cancer is currently the leading cause of cancer-related mortality worldwide, and the dominant histopathology is non-small cell lung cancer (NSCLC). Although many new targeted and immunomodulation therapies have emerged, not all patients are responsive to novel therapeutics. A more reliable and accurate risk stratification model to predict the treatment response and survival outcomes are still lacking. The 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET) derived radiomics can be used to interrogate tumor biologies such as glycolytic activity and heterogeneity. It can, therefore, be used to predict treatment response and survival outcomes. Cancer genomics derived from gene sequencing can evaluate cancer's genetic alterations. It can be used to feature the genotype of the tumor. However, both tools have drawbacks; combining these two modalities may enable a more robust predictive model for more precise clinical decisions. During the investigator's former study project, the investigators published four Science Citation Index journal papers using the investigators' research results, which found that 18F-FDG PET radiomics can independently predict regional lymph node metastasis in NSCLC and cancer survival by stage. The preliminary findings of the investigator's former research project also disclosed an association between 18F-FDG PET-derived molecular radiomics with genomic heterogeneity and mutation of specific glucose metabolic genes. This time, the investigators plan to include deep radiomics in addition to traditional handcrafted radiomics. The investigators aim to investigate the radiogenomic patterns in different driver gene mutation statuses and clinical scenarios. Finally, the investigators seek to use radiogenomics as a prognostic stratification tool in patients with NSCLC.

NCT ID: NCT05537922 Recruiting - Clinical trials for Non Small Cell Lung Cancer

I3LUNG: Integrative Science, Intelligent Data Platform for Individualized LUNG Cancer Care With Immunotherapy

Start date: October 1, 2022
Phase:
Study type: Observational

I3LUNG is an international project aiming to develop a medical device to predict immunotherapy efficacy for NSCLC patients using the integration of multisource data (real word and multi-omics data). This objective will be reached through a retrospective - setting up a transnational platform of available data from 2000 patients - and a prospective - multi-omics prospective data collection in 200 NSCLS patients - study phase. The retrospective cohort will be used to perform a preliminary knowledge extraction phase and to build a retrospective predictive model for IO (R-Model), that will be used in the prospective study phase to create a first version of the PDSS tool, an AI-based tool to provide an easy and ready-to-use access to predictive models, increasing care appropriateness, reducing the negative impacts of prolonged and toxic treatments on wellbeing and healthcare costs. The prospective part of the project includes the collection and the analysis of multi-OMICs data from a multicentric prospective cohort of about 200 patients. This cohort will be used to validate the results obtained from the retrospective model through the creation of a new model (P-Model), which will be used to create the final PDSS tool.

NCT ID: NCT05537701 Active, not recruiting - Clinical trials for Non-small Cell Lung Cancer

Tissue Eosinophils in Non-Small Cell Lung Cancer (the TEN Study)

TEN
Start date: October 3, 2022
Phase:
Study type: Observational [Patient Registry]

The primary objective is to describe eosinophil infiltration in resected (early stage) NSCLC. Secondary objectives are: - to investigate the correlation of T-Eos and B-Eos in the aforementioned patient population; - to investigate the correlation between T-Eos and overall & disease-free survival; - to investigate the localization of T-Eos (periphery vs. center of the tumor lesions).

NCT ID: NCT05534113 Not yet recruiting - Clinical trials for Non-small Cell Lung Cancer

Envafolimab Immunotherapy After ctDNA EGFR Clearance by Treatment With Almonertinib in EGFR-Mutant, PD-LI Positive NSCLC

Start date: December 1, 2022
Phase: Phase 2
Study type: Interventional

This is a prospective, single-arm, open-label, interventional clinical study, aimed at exploring the efficacy and safety of sequential Envafolimab immunotherapy after patients with ctDNA EGFR mutation clearance and achieved stable radiographically deep esponse after first line treatment with Almonertinib in EGFR-Mutant, PD-LI positive non-small-cell lung cancer.

NCT ID: NCT05532696 Recruiting - Clinical trials for Non Small Cell Lung Cancer

Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients

Start date: September 27, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

A Phase 1b/2, open-label, multicenter study to determine the recommended phase 2 (RP2D) of ABT-101in solid tumor and to explore antitumor activities of ABT-101 in patients with HER 2 mutated non-small cell lung cancer (NSCLC)

NCT ID: NCT05526755 Recruiting - Clinical trials for Stage II-IIIB Non-small Cell Lung Carcinoma

A Study of 5 Years of Adjuvant Osimertinib in Completely Resected Epidermal Growth Factor Receptor Mutation (EGFRm) Non-small Cell Lung Carcinoma (NSCLC)

TARGET
Start date: March 6, 2023
Phase: Phase 2
Study type: Interventional

To assess the efficacy and safety of osimertinib in participants with EGFRm positive stage II-IIIB NSCLC, following complete tumour resection with or without adjuvant chemotherapy.