Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

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Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Each patient with a lung nodule meeting criteria will undergo marking with fiducials followed at the same time by Video-Assisted Thoracic Surgery (VATS) lung wedge resection under CT fluoroscopy.

Video-Assisted Thoracic Surgery (VATS) wedge resection

Raphael Bueno, M.D.

This is a phase II protocol to determine the safety and feasibility of Intraoperative CT fluoroscopy guidance for lung resection for small nodules.

This is a phase II protocol to determine the safety and feasibility of image guided CT marking for resection of small lung nodules. This is relevant because many such nodules are hard to localize for minimally invasive lung resection. It is hoped that this technology using fluoro CT capability available now in most operating room will improve safety and reliability of thoracic surgery.

Percutaneous Image Guided Video-Assisted Thoracic Surgery (VATS) Resection of Lung Lesions

Percutaneous Image Guided Video Assisted Thoracic Surgery (VATS) Resection of Lung Lesions

The patient will be monitored while in the hospital by their thoracic surgical team as well as by two research nurses named Lauren Donahue, RN and Karen Magsipoc, NP. The research nurses will document any perioperative complications and mortality that arise during the patient's stay in the hospital.

Number of patients who underwent a successful resection which is measured by an accurate and appropriate resection in a given timeline

Siemens Medical Solutions USA - CSG

Brigham and Women's Hospital

Associate Chief of Thoracic Surgery; Professor of Surgery

Each patient with a lung nodule meeting criteria will undergo marking with fiducials followed at the same time by Video-Assisted Thoracic Surgery (VATS) lung wedge resection under CT fluoroscopy.

Video-Assisted Thoracic Surgery (VATS) wedge resection

CT Marking and VATS Lung Wedge Resection

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Dr. Raphael Bueno

Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0

Patients Underwent a Successful Resection

Overall Study

Multiple Pulmonary Nodules

Solitary Pulmonary Nodule

Patients with Pulmonary Lesions as seen by CT

The primary Study hypothesis is that the ProLung Test will demonstrate safety and efficacy in the risk stratification of patients with pulmonary lesions identified by CT that are suspicious for lung cancer. A statistically significant result will indicate that patients with a high ProLung Test result have a greater risk of developing lung cancer than patients with a low test result.

There are three Specific Aims of this study:

1. Optimize and confirm the stability of the ProLung Test risk-stratification algorithm in patients with a diagnosis.
2. Externally validate the efficacy of the ProLung Test risk-stratification algorithm by comparing the test result to the conclusive patient diagnosis.
3. Assess the safety and tolerability of the ProLung Test procedures.

Study Design This Study consists of two distinct phases, Stabilization and Validation. The Study will collect data from multiple sites (3 to 12), and each site may enroll patients and collect data for the Stabilization and Validation Phases with a minimum of three sites for the Validation Phase.

A Multi-Center Trial of the ProLung Test™

A Multi-Center Trial of the ProLung Test™ (Transthoracic Bioconductance Measurement) as an Adjunct to CT Chest Scans for the Risk Stratification of Patients With Pulmonary Lesions Suspicious for Lung Cancer

Demonstrate safety and efficacy in the risk stratification of patients with pulmonary lesions identified by CT that are suspicious for lung cancer.

Huntsman Cancer Institute

University of California, Los Angeles

Henry Ford Health System

University of California, San Diego

Intermountain Health Care, Inc.

M.D. Anderson Cancer Center

Greater Baltimore Medical Center

Stanford University

Loyola University

Providence Health Center

Wake Forest

University of Minnesota Masonic Cancer Center

Beth Israel Deaconess Medical Center

Medical University of South Carolina

Fresh Medical Laboratories

Indeterminate Pulmonary Lesions

Race

Race/Ethnicity, Customized

Michael Garff, Chief Operating Officer

Positive Predictive Value

Negative Predictive Value

Sensitvity

Specificity

Validation set of patients with indeterminate lung nodules

Clinical Efficacy in the Risk Stratification of Patients With Indeterminate Lesions

Each patient with a lung nodule meeting criteria will undergo a lung resection which could be one of three approaches: iVATS with Dyna-CT, VATS, or open. Each approach will use a the experimental device the Lung Resection Marker Locator Kit

Nodules eligible for surgical resection using the Lung Resection Marker Locator Kit

lung resection with Lung Resection Marker Locator Kit

This is an open label study lung nodules that are either cancer or non-cancer and who are eligible for surgical resection. Patients will undergo their surgery with the help of the Lung Resection Marker Locator Kit which will assist the surgeon in both the location and resection of the lung nodule under real-time guidance.

Image - Navigated Resection of Lung Nodules

To determine whether a coefficient needs to be defined to harmonize the distance measured with the device to that found by pathologists

3. To determine the length of time needed for the placement of the device and record measurements.

no increased surgical morbidity from the operation

Navigation Sciences, Inc.

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Patient is undergoing electromagnetic navigation bronchoscopy using Medtronic super D version 7 EMN system, peripheral endobronchial ultrasound and Cone Beam CT Guidance using the Philips Azurion 7 C20 FlexMove with Embo Guide and Overlay software to create CT Augmented Fluoroscopy under general anesthesia.

Patient is undergoing robotic navigation bronchoscopy using IOn robotic platform, peripheral endobronchial ultrasound and Cone Beam CT Guidance using the Philips Azurion 7 C20 FlexMove with Embo Guide and Overlay software to create CT Augmented Fluoroscopy under general anesthesia.

Replace the Super-D EMN navigational platform with Ion Robotic bronchoscopy platform guided with shape sensing technology

Robotic Bronchoscopy

Navigational bronchoscopy (NB) is used to access peripheral and central parenchymal lung lesions via endobronchial and transbronchial approach. Currently there are multiple platforms available to provide guidance to reach the peripheral and central lesions in the lung which are inaccessible via traditional video bronchoscopy. Traditionally NB is done under fluoroscopic guidance using C-arm but with development of Cone Beam CT and 3D reconstruction technology, fluoroscopy can be enhanced to much higher resolution and can also provide real time 3D augmentation of the lesion. It also enables the user to obtain a CT of the Chest to confirm the real time location of the lesion and the bronchoscopic biopsy catheter and instruments. This has proven to improve the yield and sensitivity of Navigational bronchoscopic guided Biopsy of the lung nodules and masses. Out of the various navigational platforms we have, most of them are based on Electromagnetic guidance and some on Shape sensing technology. Some of the platforms have fixed angle catheter while the newer robotic platforms have articulating catheters with much more range of motion. So far we do not have any data directly comparing the diagnostic yield of Electromagnetic navigational bronchoscopy with Robotic shape sensing guided bronchoscopy while using Cone Beam CT and Augmented fluoroscopy with both the platforms. With my study, I want to examine the change in diagnostic yield and sensitivity of fixed angle ENB guided bronchoscopy and articulating robotic shape sensing bronchoscopy both using Cone Beam CT with 3D reconstruction.

Navigation bronchoscopy (NB) has been used for more than a decade to access peripheral and central parenchymal lung lesions bronchoscopically. Traditionally standard fluoroscopy using C-arm is used to confirm the location and guide the biopsy instruments under real-time guidance. With availability of Cone Beam CT, fluoroscopic images of much higher quality and resolution can be obtained intra-operatively. It also enables the bronchoscopist to obtain intraoperative CT images and confirm the exact location of the lesion and the Bronchoscopic biopsy catheter or the biopsy instruments.

Recently we have had significant advancements in the technology to guide and operate the instruments used to reach these hard to reach lesions within the lungs. We have different fixed angle electromagnetic guided platforms, articulating robotic electromagnetic guided platforms and articulating robotic shape sensing guided platforms.

At my institution, lung nodules/masses requiring NB has evolved over the years starting from Medtronic Super-Dimension Version 7 Electromagnetic Navigational Bronchoscopy (ENB) system to ION Robotic Bronchoscopy platform (RNB). All the procedures are done under fluroscopic guidance which has also evolved from a regular C-Arm to Philips Cone Beam CT with Augmented Fluoroscopy.

During this evolution we have had Medtronic Super-D ENB with 2D fluoro followed by Medtronic Super-D ENB with CBCT and Augmented fluoroscopy and now have the Ion robotic platform with CBCT and Augmented fluoroscopy with low dose protocol.

All the lesions are confirmed using peripheral/radial Endobronchial Ultrasound (rEBUS). Once the appropriate location is reached, biopsy is obtained using FNA (18G or 21G), Single or Triple needle brush, Transbronchial forceps and Bronchoalveolar lavage is done for cytology or micro studies if needed.

A pathologist is present on site for all the cases to review the slides and assist in diagnosis. All the cases are done under general anesthesia through endotracheal tube.

Also, all the NB procedures have been performed by one Interventional Pulmonologist since August 2017.

For the interventional arm, all the aspects will remain the same except that the procedure will utilize Ion Robotic bronchoscopy platform and pre-operatively every patient will undergo incentive spirometry, dual short acting bronchodilator treatment and will be maintained at relatively higher PEEP and Lower FiO2 than before.

The diagnostic yield will be compared to the patients who underwent procedure using Super-D Electromagnetic platform with CBCT and Augmented Fluoroscopy.

All cases are still done in Hybrid ORand all the patients are completely paralyzed intra-operatively. Also, all procedures in both arms will use a Philips Azurion 7 C20 FlexMove system with Emboguide, 3D Segmentaion and Overlay tools. This enables the bronchoscopist to obtain a CT scan of the chest and also segment out the lesion(s) of interest and to overlap the 3-D image of the lesion on live fluoroscopy in all 3 dimensions.

During the ENB and RNB procedures, at least 1 full Xpert CT is obtained, mostly after completing the airway registration and advancing the guided catheter to the lesion of interest. Once the extended working channel and the locatable guide or The robotic articulating catheter is advanced to the lesion using ENB/Shape sensing guidance, the catheter is held at that position and patient is maintained in inspiratory breath hold and Cone Beam CT is used to obtain the Xpert CT that shows the lesion and surrounding lungs, chest and mediastinal structures in the surrounding area of the chest. This is then used to analyze the location of the lesion and the lesion of the extended working channel/robotic catheter and the biopsy instruments in relation to the lesion. The lesion is then segmented and EmboGuide + Overlay feature is used to project a 3D view of the lesion on the live fluoroscopic images in all three axis. This also allows the bronchoscopist to obtain Anterior-posterior, Lateral and oblique views at various angles while maintaining the 3D overlap.

Additional CT scans might be obtained intra-operatively if needed to guide the biopsy catheter appropriately towards the lesion.

Due to the live nature of the Cone Beam CT, it is much more capable of providing accurate guidance regarding the location of the lesion and the biopsy instruments. hence, in case of any discrepancy, information provided by Cone Beam CT is considered more reliable and used with higher confidence.

Rest of the steps involved in procedure are similar between the control and the interventional arm including the surgeon, type of biopsy instruments, use of peripheral Endobronchial Ultrasound and availability of on-site pathologist. The biopsy instruments include transbronchial needle for FNA, Single or triple needle brush and transbronchial forceps. Bronchoalveolar lavage is also obtained at the end via working channel.

All the patients undergoing biopsy of the peripheral/central lung lesions using ENB/RNB also undergo Convex EBUS guided mediastinal surveillance and EBUS-TBFNA of any Lymph Node that appears to be greater than 5 mm on EBUS exam.

My study aims to study the difference in diagnostic yield and sensitivity of electromagnetic navigational bronchoscopy with fixed angle catheter vs robotic shape sensing bronchoscopy with articulating catheter while using Cone Beam CT with segmentation, 3-D overlay and CT augmented fluoroscopy for diagnosis of peripheral and central lung lesions including lung nodules and masses which could not be directly accessed using just white light bronchoscope.

Cone Beam CT Guided Robotic Navigational Bronchoscopy

Comparing Diagnostic Yield of Real Time Cone Beam Computer Tomography Guided Electromagnetic Navigational Bronchoscopy With Cone Beam Computer Tomography Guided Robotic Navigational Bronchoscopy for Peripheral and Central Lung Lesions

Percentage of malignant lesions accurately diagnosed on biopsy

Percentage of correct underlying diagnosis

Will have a record of radiation dose from the Cone Beam CT data for both the arms.

Columbus Regional Health

Medical Director, Lung Institute and Section Chief, Pulmonary & Critical Care

Ernest Scalzetti, MD

The purpose of this study is to compare the features that the pathologist sees, when examining a lung tumor under the microscope, to the way that the tumor appears on the computed tomography (CT) scan. Features of the tumor may include abnormal blood vessels and areas in which tumor cells are dying. The samples that are taken during the needle biopsy contain information from one small part of the tumor. The investigators believe that they can show where in the tumor the samples came from, based on the CT scans during the biopsy procedure. If the investigators can accurately determine where in the tumor their samples came from, they can compare the features of that part of the tumor, as seen on the CT images, to the features of that part of the tumor as seen under the microscope. This research study also will give the investigators an idea of how much the biopsy samples are distorted in the process of preparing them for examination under the microscope.

Newer cross-sectional imaging methods allow improved visualization of anatomic detail-for example, high-resolution CT has a spatial resolution of less than 1 mm in all 3 dimensions. These imaging methods also provide a limited amount of physiologic information-for example, tumor perfusion as demonstrated by enhancement with intravenous contrast agents. Radiologic-pathologic correlation in the current era gives us the opportunity to work on a finer spatial scale and to take advantage of the additional physiologic information. Pathologic assessment of tissue has evolved at the same time. Tissue can be stained in the traditional way for microscopic evaluation but newer tools such as immunohistochemistry and, most recently, methods of molecular biology can be applied as well.

We are interested in radiologic-pathologic correlation in lung tumors. Tumors are known to be heterogeneous; we want to develop an approach that will allow us to explore their spatial organization. We cannot rely on surgical resection to provide tissue for pathologic evaluation, because the majority of lung lesions never come to resection. For example, only \~15% of lung cancer patients are surgical candidates. The remainder would be lost to the classical approach that depends on surgery. Percutaneous needle biopsy provides an alternative means of tissue sampling. This is a safe, effective and commonly used way to obtain samples of tissue ("core samples") from any given lung mass. The pathologist can process these core samples in the same way as a surgical specimen.

Correlation of X-ray and Pathology With Needle Biopsy of Lung Tumors

Pilot Study of Radiologic-Pathologic Correlation in Lung Tumors Based on Core Needle Biopsy

State University of New York - Upstate Medical University

Image guided Video-assisted thoracoscopic surgery (VATS) in either one of two hybrid operating rooms and Fine Needle Aspiration (FNA) under fluoroscopy.

Standard video-assisted thoracoscopic surgery (VATS) in operating room and Fine Needle Aspiration (FNA) in pathology frozen section room.

Image guided placement of a fiducial consisting of a needle directed placement of a T-Bar next to the target lesion in order to lead the surgeon to the lung region to be removed

Image guided Video-Assisted Thoracic Surgery (VATS) resection

Standard of Care Video-Assisted Thoracic Surgery (VATS) resection

Video-Assisted Thoracic Surgery

Julianne S Barlow

Raphael Bueno, MD

Julianne Barlow

To evaluate workflow and outcomes of iVATS and standard VATS for small pulmonary nodules. The outcomes of the patients will be evaluated separately as there will be no direct comparison of the two arms.

This is a prospective phase II clinical study to evaluate iVATS and standard VATS for small pulmonary nodules. We have successfully completed and published a phase I/pilot study with 25 patients demonstrating safety and optimal procedural workflow for combining image-guidance with VATS. This phase II clinical study will further expand upon the safety and feasibility of this procedure. Additionally, this data will be used to design a phase III comparison study between iVATS and standard VATS.

Image Guided VATS vs. VATS Resection

Image Guided VATS Resection vs. VATS Resection of Lung Lesions

To collect imaging data from pre-operative and post-operative CT scans for quantitative analysis from both arm.

The time (in min.) from incision to close

The time from patient ready for surgery to placement of t-bar

Time (in min) from induction to incision made

Length of hospital stay (in days) in both arms

The radiation exposure (mSV) in the iVATS arm

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Percutaneous Image Guided Video-Assisted Thoracic Surgery (VATS) Resection of Lung Lesions	NCT01847209	Lung Cancer	Video-Assisted ...	18 Years -	Brigham and Women's Hospital
A Multi-Center Trial of the ProLung Test™	NCT01566682	Solitary Pulmon... Multiple Pulmon...		18 Years -	Fresh Medical Laboratories
Image - Navigated Resection of Lung Nodules	NCT04702165	Lung Diseases	lung resection ...	21 Years -	Navigation Sciences, Inc.
Cone Beam CT Guided Robotic Navigational Bronchoscopy	NCT05358041	Lung Nodule Lung Mass Lung Cancer	Robotic Broncho...	18 Years -	Columbus Regional Health
Correlation of X-ray and Pathology With Needle Biopsy of Lung Tumors	NCT00638625	Lung Neoplasm		18 Years -	State University of New York - Upstate Medical University
Image Guided VATS vs. VATS Resection	NCT03623958	Lung Cancer	Image guided Vi... Video-Assisted ...	18 Years -	Brigham and Women's Hospital
Image Guided VATS vs. VATS Resection	NCT03623958	Lung Cancer	Image guided Vi... Video-Assisted ...	18 Years -	Brigham and Women's Hospital
Correlation of X-ray and Pathology With Needle Biopsy of Lung Tumors	NCT00638625	Lung Neoplasm		18 Years -	State University of New York - Upstate Medical University

Spots Global Cancer Trial Database for lung mass

Every month we try and update this database with for lung mass 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 mass

Every month we try and update this database with for lung mass 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 mass 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.