Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Blood and Lymph Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Eosinophilia

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Leukocyte Disorders

Hematologic Diseases

Reproductive Control Agents

Respiratory System Agents

All Drugs and Chemicals

Albuterol

Dimercaprol

Chelating Agents

Eosinophils will be measured in blood, sputum, bronchoalveolar lavage if available and biopsies.

After premedication with 400 μg inhaled salbutamol, sputum will be induced by inhalation of hypertonic (NaCl 3%) or isotonic (NaCl 0.9%) saline combined according to the FEV-1 value (\> or ≤ than 65% predicted). Saline will be combined with additional salbutamol delivered by an ultrasonic nebulizer (Ultra-Neb 2000; Devilbiss, Somerset, PA, USA) with an output set at 0.9 ml/min. Each subject will inhale the aerosol for three consecutive periods of 5 min for a total of 15 min. For safety reasons, FEV-1 will be monitored throughout the induction and will be stopped if FEV-1 would fall by more than 20% from baseline.

induced sputum

As per standard practice, biopsies will be taken from the primary tumour site or from a metastatic site.

lung biopsy

When available, the remaining material from a patient's bronchoalveolar lavage will be collected.

bronchoalveolar lavage

As per standard practice, blood will be drawn from patients before and during treatment. Data on white blood cells will be collected.

blood draw

Anne Sibille, MD

Aurore Cue Alvarez

This prospective study will examine eosinophils in various biological materials to compare the detection in those materials and ascertain the prognostic and predictive role of eosinophils in untreated non-small cell lung cancer patient.

PROspective Trial on EOsinophilia in Non-Small Cell Lung Cancer (NSCLC).

PROspective Trial on EOsinophilia in Non-Small Cell Lung Cancer (NSCLC) (PROTEON).

Concentration of eosinophils will be used in various bodily materials as described above.

Centre Hospitalier Universitaire de Liege

Dr Anne Sibille

Video

2 questionnaires pre and post procedure taking approximately 15 minutes each to complete.

Questionnaires

Stephen McRae, MD

Objective:

To compare changes in patient anxiety levels between groups of patients who either were or were not exposed to an informative multimedia patient education tool, in order to determine how the addition of such a multimedia tool will affect this parameter. Specifically, the study will focus on subjective anxiety as measured on pre procedure and post procedure patient surveys as detailed under study components.

If you agree to take part in this study, you will complete a questionnaire that asks how you feel before the procedure. It will take about 5 minutes to complete.

After you have completed the questionnaire, you will be randomly assigned (as in the flip of a coin) to Group 1 or Group 2. You will have an equal chance of being in either group.

If you are in Group 1, you will receive routine information before the lung biopsy and you will watch a video on a handheld or laptop machine with headphones. The video is designed to help you understand the biopsy procedure. This video should last about 5 minutes. You will then complete a questionnaire that asks how you feel after watching the video. It will take about 5 minutes to complete.

If you are in Group 2, you will receive routine information before the lung biopsy. You will then complete another questionnaire that asks how you feel before the procedure. It will take about 5 minutes to complete.

After your routine lung biopsy, both groups will complete a questionnaire that asks how you feel after the procedure. It will take about 5 minutes to complete.

For Group 1, the total time to complete the questionnaires and watch the video will be 20 minutes.

For Group 2, the total time to complete the questionnaires will be 15 minutes.

Length of Study:

Your participation in this study will be over once you complete the questionnaire after your lung biopsy.

This is an investigational study.

Up to 100 patients will take part in this study. All will be enrolled at M. D. Anderson.

Multimedia Patient Education

Increasing Patient Preparedness for the Procedural Experience and Improving Qualitative Outcomes Through Patient Education

Subjective anxiety as measured on pre procedure and post procedure patient surveys.

M.D. Anderson Cancer Center

Pneumothorax

Experimental lung plug after the lung biopsy.

The standard lung biopsy without placement of the plug.

The lung plug will be inserted into the left track when the biopsy needle is removed. The smaller sampling needle is removed, and the lung plug is inserted through the larger needle using a delivery tool that has a plunger to push the plug in place. The lung plug remains in the track left when the larger needle is removed.

Bio-Seal Track Plug

Standard lung biopsy without placement of the plug.

No lung plug

Sanjay Gupta, MD

The purpose of this study is to demonstrate safety and effectiveness of the Bio-Seal Biopsy Track Plug in a clinical setting for use in lung biopsy procedures to reduce the rate of air leaks, commonly associated with the procedure. The Bio-Seal System is cleared in the U.S. with an indication for use as a lung biopsy site marker.

Air leaks are the most common problem after a lung biopsy. Air leaks can be mild to severe. Mild air leaks are monitored by chest x-ray and may go away by themselves. Air leaks can cause pain and require repeated x-rays, and in some cases the need for a tube to be inserted into the chest for drainage of the air.

If you agree to take part in this study, you will be randomly assigned (as in the toss of a coin) to 1of 2 groups. Participants in one group will receive the experimental lung plug after the lung biopsy. Participants in the other group will just have the standard lung biopsy without placement of the plug. There is an equal chance of being assigned to either group.

All participants will have the routine lung biopsy performed by their doctor with the aid of a computerized tomography (CT) scan. During a lung biopsy, a needle is inserted into the mass in the lung using the CT for guidance. A smaller needle is then inserted through the first needle to collect a sample of the tissue.

If you are assigned to receive the lung plug, it will be inserted into the track left when the biopsy needle is removed. The smaller sampling needle is removed, and the lung plug is inserted through the larger needle using a delivery tool that has a plunger to push the plug in place. The lung plug remains in the track left when the larger needle is removed.

Regardless of which group you are assigned to, you will be receive the same follow-up treatment. The rates of air leaks after the lung biopsy will be compared between 2 groups of participants. This will provide researchers with the data to learn if the lung plug should be used for all patients receiving a lung biopsy to decrease the number of air leaks.

Your doctor will watch you carefully for air leaks. You will have a chest x-ray about 1 hour after the procedure to again check for air leaks. If a leak is detected, you will receive the normal treatment for air leaks, which includes chest x-rays on a regular basis. If the air leak grows, you may need a chest tube placed for drainage. It is possible that this may require you to stay in the hospital overnight. In the most extreme cases, additional surgery may be needed to stop the air leak. Over time, your body will absorb the plug. A final x-ray will be taken 1 month after the biopsy to be sure that an air leak has not developed.

You will be asked to be in the study for 30 days. This will include the time you spend in the hospital for the biopsy and, if you have an air leak, the entire time you spend in the hospital, if it needs to be treated. In addition, you will return to your doctor the day following the biopsy and 30 days later to have a chest x-ray to look for any late air leaks.

Evaluation of the Bio-Seal Biopsy Track Plug

A Prospective Randomized Multi-Centered Study and Efficacy Evaluation of the Bio-Seal Biopsy Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy Procedures

Treatment Success defined as absence of pneumothoraces to measure the effects of the hydrogel plug in three follow-up radiographic assessment (x-rays post procedure by 0-60 minutes, 24 hours and 30 days).

Pleural Plug

No Pleural Plug

Total

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Intent-to-treat (ITT) population of all subjects who were randomized.

Number of Participants With Absence of Pneumothoraces

Overall Study

Narinder Paul, FRCP C

This study is a comparison of core needle biopsy with fine needle aspiration biopsy in the evaluation of lung nodules.

Computed Tomography (CT) Guided Lung Biopsy: Core or Fine Needle Aspiration

CT Guided Lung Biopsy: Core or Fine Needle Aspiration

University Health Network, Toronto

4D electromagnetic navigation bronchoscopy (4D-ENB) for lung biopsy. Guidance based on tip tracked surgical tools and images calculated from CT.

Bronchoscopic lung biopsy taken while using X-ray fluoroscopy.

Electromagnetic navigational bronchoscopy system with tip tracked instruments.

ENB with image-guided lung biopsy

Bronchoscopic lung biopsy with fluoroscopy.

Conventional Bronchoscopy guided by Fluoroscopy

Cathaly Hong

Hu Jian, MD

Bai Chong, MD

Sun Jiayuan, MD

Li Qiang, MD

Evaluate results for participants with lung lesions randomized to either 4D Electromagnetic Navigation Bronchoscopy (4D-ENB) versus Conventional Bronchoscopy with Fluoroscopy for diagnostic biopsy and detection of lung cancer.

The objective of this clinical trial is to evaluate the safety and efficacy results for two bronchoscopic biopsy techniques for sampling lung lesions: either image-guided electromagnetic navigation or conventional bronchoscopy with fluoroscopy. The diagnostic yield and adverse events of participants prospectively randomized to either arm will be evaluated. This is a prospective, randomized, multi-center study.

ENB Vs. Conventional Bronchoscopy With Fluoroscopy for Safe and Effective Biopsy of Pulmonary Lesions

A Prospective, Randomized, Multi-center, Superiority Clinical Study to Evaluate the Effectiveness and Safety of Bronchoscopic Lung Biopsy Under the Guide of CT Stereotactic Auxiliary Equipment and Accessories

Diagnostic rate is defined as the proportion of true positive and true negative.

Sampling success rate means the proportion of lung nodules and abnormal lung tissues in all tissues sampled from bronchoscopic lung biopsy.

For this outcome, duration of procedure is defined as the time from the biopsy tool reaching the main carina (registration) to the biopsy tool reaching the lesion.

For this outcome, duration of procedure is defined as the time from the bronchoscopy accessing the glottis for the first time to bronchoscopy exiting the glottis for the last time.

Navigation success rate is defined as the proportion of the biopsy tools reaching the lung tissues. For this outcome, duration of procedure is defined as the time from the biopsy tool reaching the main carina (registration) to finishing the biopsy for the last time.

Device performance means the functions, reliability, safety and accessibility of the system. Performance will be evaluated by observing these characteristics during the procedure. For this outcome, duration of procedure is defined as the time from the biopsy tool reaching the main carina (registration) to finishing the biopsy for the last time.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PROspective Trial on EOsinophilia in Non-Small Cell Lung Cancer (NSCLC).	NCT05602259	Non-small Cell ...	induced sputum lung biopsy bronchoalveolar... blood draw	18 Years -	Centre Hospitalier Universitaire de Liege
PROspective Trial on EOsinophilia in Non-Small Cell Lung Cancer (NSCLC).	NCT05602259	Non-small Cell ...	induced sputum lung biopsy bronchoalveolar... blood draw	18 Years -	Centre Hospitalier Universitaire de Liege
Multimedia Patient Education	NCT01184534	Lung Cancer	Video Questionnaires	18 Years -	M.D. Anderson Cancer Center
Evaluation of the Bio-Seal Biopsy Track Plug	NCT00527722	Lung Cancer	Bio-Seal Track ... No lung plug	18 Years -	M.D. Anderson Cancer Center
Computed Tomography (CT) Guided Lung Biopsy: Core or Fine Needle Aspiration	NCT00188526	Lung Cancer	lung biopsy	16 Years -	University Health Network, Toronto
ENB Vs. Conventional Bronchoscopy With Fluoroscopy for Safe and Effective Biopsy of Pulmonary Lesions	NCT04447482	Lung Neoplasms Pulmonary Neopl...	ENB with image-... Conventional Br...	18 Years - 75 Years	Shanghai Youhe Medical Technology Co., Ltd.
Evaluation of the Bio-Seal Biopsy Track Plug	NCT00527722	Lung Cancer	Bio-Seal Track ... No lung plug	18 Years -	M.D. Anderson Cancer Center
Evaluation of the Bio-Seal Biopsy Track Plug	NCT00527722	Lung Cancer	Bio-Seal Track ... No lung plug	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for lung biopsy

Every month we try and update this database with for lung biopsy cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for lung biopsy

Every month we try and update this database with for lung biopsy cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for lung biopsy cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.