Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Minimally Invasive Echo-Endoscopic Lymph Node Evaluation and Biopsy

Endoscopic Ultrasound (EUS)

Minimally Invasive Echo-Bronchoscopic Lymph Node Evaluation and Biopsy

Endobronchial Ultrasound (EBUS)

Moishe Liberman, MD, PhD

The purpose of this study is determine if performing endobronchial ultrasound (EBUS) in addition to standard endoscopic ultrasound (EUS) can increase the precision and accuracy of staging esophageal cancer in comparison to EUS alone. The expectation is that EBUS can be used to biopsy lymph nodes that: (1) because of their position in the mediastinum would be inaccessible to EUS, or (2) would be inaccessible due to their position behind the esophageal tumor.

1. Problem:

   Endoscopic ultrasound techniques are becoming more and more popular. The safety of these technologies has been demonstrated on multiple occasions. These minimally invasive trans-luminal techniques do not require general anesthesia and can be performed, rapidly, accurately and at low cost. Endobronchial ultrasound (EBUS) has been used by pulmonologists and thoracic surgeons primarily for the staging, diagnosis and management of lung cancer. Its efficacy and safety has been demonstrated in multiple studies.

   EBUS is not currently utilized by most centers in the staging of esophageal cancer. To date, no study has explored the possible use of EBUS for peritumoral lymph node biopsy, nor for biopsy of any suspicious mediastinal lymph nodes, not accessible by EUS. At Notre Dame Hospital, Centre Hospitalier de L'Universite de Montreal, all patients diagnosed with esophageal cancer undergo complete EUS staging followed by EBUS during the same procedure, in order to examine all the lymph nodes near or far from the primary tumor amenable to EBUS guided trans-bronchial biopsy. This is important because it allows physicians to bypass the primary tumor and pass through the normal (non-cancerous) bronchial wall, eliminating any chances of tumoral contamination of the sample. In addition, this also provides a much more complete mediastinal staging as it allows biopsy of a population of lymph nodes non-accessible to EUS biopsy. Thus far, we have performed EBUS in six patients with esophageal cancer with upstaging of the N stage of the tumor in two of these patients (33%). There have been no morbidities and all patients have been discharged home on the day of the procedure. EBUS was therefore able to change the treatment strategy, without adding any morbidity, discomfort or additional procedural time for two out of six patients.

   The proposed project will be the first study ever to evaluate the impact of EBUS on esophageal cancer staging as well as on the choice of therapy. This study consists of a prospective cohort study with no placebo group, all patients will have EBUS and stages obtained with and without EBUS will be compared as well as changes to the treatment plan based on EBUS staging.
2. Objectives:

   * Examine the impact of adding EBUS to the gold standard work-up on esophageal cancer staging.
   * Examine the impact of adding EBUS to the gold standard work-up on the treatment plan for patients newly diagnosed with esophageal cancer.
3. Methodology:

   The study consists of a prospective cohort study. Each patient will serve as his/her own control. All patients currently undergoing esophageal cancer staging in the Division of Thoracic Surgery at the CHUM will be approached for enrolment into the study.

   EUS followed by EBUS will be performed during the EUS staging procedure. The order of procedures for all patients is as follows: (1) Flexible Esophagoscopy with endoluminal biopsy, (2) Radial EUS for T staging (3) Linear EUS for lymph node biopsy and N staging, (4) Flexible Bronchoscopy for evaluation of the left mainstem bronchus for tumor invasion, (5) Linear EBUS for trans-tracheal and trans-bronchial lymph node biopsy.

   All FNA samples will be evaluated using standard methods by cytopathologists at the CHUM. Results will be evaluated for: (A) positivity, (B) negativity (no tumor cells, positive lymphocytes), (C) inadequacy (no tumor cells, no lymphocytes). A minimum of two passes will be performed into each lymph node.

   Patients will be discharged on the same day, as their procedure. Results will be discussed with them in a follow-up clinic appointment with their thoracic surgeon within 3 weeks of the procedure. Any procedure-related morbidity will be documented in the post-procedural period as well as at their follow-up appointment.
4. Expected Results:

We believe that by adding EBUS to the gold standard work up and staging of esophageal cancer, we can make a significant difference in esophageal cancer staging. This may also significantly change the choice of therapy.

Endobronchial Ultrasound (EBUS) for Nodal Staging in Esophageal Cancer

C.E.T.O.C. - CHUM Endoscopic Tracheobronchial and Oesophageal Center

Marcel and Rolande Gosselin Chair in Thoracic Surgical Oncology

Fonds de la Recherche en Santé du Québec

Centre de Recherche du Centre Hospitalier de l'Université de Montréal

Centre hospitalier de l'Université de Montréal (CHUM)

Symptoms and General Pathology

Cysts

Pancreatic Cyst

Pancreatic Diseases

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

The investigators are testing a new method called confocal laser endomicroscopy to see if it can detect pre-cancerous abnormalities in the lining of the cysts found in your pancreas. This will involve using a very thin fiber-shaped microscope which will be passed through a needle during the EUS procedure.

The investigators will do the standard EUS procedure. If a cyst is seen in the pancreas during EUS, the investigators will administer a special dye called fluorescein through the IV, and then use the new fiber-shaped microscope to take pictures of the lining of the cysts.

Michael B. Wallace, MD

Confocal laser endomicroscopy (CLE) is a novel and highly promising imaging method for that allows in vivo imaging of the mucosal layer at resolution of approximately 1 micron. Cellular and sub-cellular structures as well as capillaries and single red blood cells can be visualized. CLE is now well established as a highly accurate method for distinguishing neoplasia in the gastrointestinal tract lumen via endoscopy. A major new breakthrough is the development of sub-millimeter CLE probes that can be passed via an image guided needle (nCLE) into solid organs and cysts.

It is hypothesized that nCLE will help distinguish the benign, premalignant and malignant cystic lesions of pancreas by visualizing the cellular lining of the cysts, thereby, avoiding unnecessary surgery in patient with benign cysts and guiding to early and effective surgical removal of high risk neoplastic lesions.

A prototype minimal risk nCLE system has been developed that can be passed via standard endoscopic ultrasound needles into the pancreas but FDA clearance for in vivo use is not expected until late 2010. The investigators propose to evaluate this prototype nCLE system in vivo during endoscopic ultrasound (EUS), as an initial pilot study.

Hypothesis: the confocal laser endomicroscopy imaging of the nCLE can differentiate between non-mucinous, mucinous non- malignant and malignant pancreatic cysts in vivo and has increased sensitivity compared to endoscopic ultrasound-fine needle aspiration (EUS-FNA) tissue sampling. In this pilot study the investigators will primarily evaluate technical feasibility and interobserver agreement.

1. In patients undergoing EUS for suspected pancreatic cysts, the investigators will evaluate the key nCLE image features of non mucinous, mucinous, and malignant pancreatic cystic neoplasms (PCN).
2. The investigators will estimate the initial image quality, feasibility, and interobserver agreement of nCLE
3. The investigators will establish the preliminary accuracy of nCLE to be used for planning a larger comparative trial

Confocal Endomicroscopy of Pancreatic InVivo

Detection of Neoplastic Pancreatic Cysts Using Probe Based Confocal Laser Endomicroscopy: A Prospective in Vivo Study

Mauna Kea Technologies

Mayo Clinic

Michael B. Wallace, MD MPH

Ear, Nose, and Throat Diseases

Adenocarcinoma

Deglutition Disorders

Cryotherapy employs thermal ablation to treat esophageal cancer and BE. Ablation is achieved by intracellular disruption and ischemia that is produced by freeze-thaw cycles using liquid nitrogen or carbon dioxide

Cryotherapy

EGD is a diagnostic procedure that allows the physician to diagnose and treat problems in the upper gastrointestinal (UGI) tract. The doctor uses a long, flexible, lighted tube called an endoscope.

Esophagogastroduodenoscopy (EGD)

EUS is a procedure that allows a doctor to obtain images and information about the digestive tract and the surrounding tissue and organs, including the lungs. Ultrasound testing uses sound waves to make a picture of internal organs.

Endoscopic ultrasound (EUS)

Vladimir M Kushnir, MD

Thomas G Hollander, RN

Esophageal adenocarcinoma (EAC) is one of the few cancers with a rising incidence in the United States, with an estimated 17,000 new cases diagnosed in 2012. Most patients with esophageal cancer present with tumors which are not amenable to surgery and are treated with chemotherapy and radiation. The most common and bothersome symptoms from esophageal cancer is dysphagia (difficulty swallowing). Chemotherapy and radiation are effective in shrinking tumors and allowing patients with EAC to swallow more easily; however it usually takes 1-2 months for swallowing to improve with this treatment.

Another method of shrinking esophageal tumors and allowing for better swallowing is endoscopic spray cryotherapy (freezing the tumor from inside the esophagus with the aid of an endoscope); cryotherapy is a well established method for treating cancerous and pre-cancerous esophageal disease. This is a particularly attractive treatment option, as patients with esophageal cancer usually undergo endoscopy on several occasions before starting treatment in order to biopsy and evaluate the tumor.

The goal of this study is to evaluate the effectiveness of cryotherapy in treating EAC related dysphagia in patients who are getting ready to start chemotherapy and radiation.

In order to do this the investigators are planning to invite patients who are already undergoing endoscopy for pre-chemotherapy evaluation of known EAC. Patients would undergo cryotherapy after the diagnostic portion of the endoscopy has been completed. After the cryotherapy patients will be contacted by phone in order to evaluate change in symptoms, 2 and 4 weeks after cryotherapy.

Endoscopic spray cryotherapy (EC) is a novel modality for destruction of tissue in the gastrointestinal tract. EC involves the endoscopic application of cryogen \[liquid nitrogen (LN)\], which destroys tissue by rapid freezing and slow thawing. Immediate effects from tissue freezing include failure of cellular metabolism, membrane damage and local ischemia. Delayed effects may include apoptosis of cancer cells and immune mediated tumor destruction. EC has been used for the treatment of mucosal EAC and palliation of malignant dysphagia since 2007 in multiple tertiary centers, including Washington University in St Louis, with positive results. EC is an attractive modality for the palliation of malignant dysphagia in EAC due to the fact that newly diagnosed patients undergo upper endoscopy (EGD) and endoscopic ultrasound (EUS) as part of initial staging; thus EC could be delivered at the time of the staging endoscopy, without burdening the patient with an additional procedure. However, prospective studies on the efficacy of EC in the short term palliation of malignant dysphagia in EAC have not been performed.

Thus, the goal of this pilot study is to evaluate the effectiveness of EC in the short term palliation of malignant dysphagia in patients with unresectable EAC.

Cryotherapy for Malignant Dysphagia in Patients With Advanced Esophageal Cancer

Palliation of Malignant Dysphagia With Spray Cryotherapy in Patients With Advanced Esophageal Cancer: A Pilot Study

Results of the re-staging PET-CT will be abstracted from the medical record to document presence or absence of a pathologic complete response

Results of the surgical explant will be abstracted from the medical record to document presence or absence of a pathologic complete response.

Hunter Holmes Mcguire Veteran Affairs Medical Center

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Endocrine Gland Neoplasms

Endocrine System Diseases

Pancreatic Cancer

Immunologic Factors

Alberto Larghi, MD

Carolina Gualtieri

Guido Costamagna, MD, Prof.

Pancreatic ductal adenocarcinoma (PDAC) complexity, where genetic, stromal, and immunological factors all interact with each other, is responsible for the overall poor response of PDAC to chemotherapeutic agents, making this a lethal disease. The investigators hypothesize that: (i) dissection of genetic, stromal, and immunological factors on endoscopic ultrasound fine needle biopsy (EUS-FNB) tissue samples from unresectable PDAC patients' will allow to determine prognostic factors in this patient population; (ii) treatment response and acquisition of tumor chemotherapy resistance could be related to genetic heterogeneity between the primary and metastatic sites and alteration of the molecular profile under drug' selection pressure.

Genetic, Microenvironmental, and Immunological Factors in Unresectable Pancreatic Ductal Adenocarcinoma

To assess the impact of comprehensive genetic, stromal, and immunological factors on PFS defined as the time from the date of trial entry until disease progression or relapse.

To assess the impact of comprehensive genetic, stromal, and immunological factors on Overall survival defined as the length of time (in days) between the treatment date and the date of death.

Catholic University of the Sacred Heart

Professor

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Cervical Mediastinoscopy

The gold standard techniques to assess the extent of disease and decide on therapy for patients with lung cancer consists of cervical mediastinoscopy, which is a surgical procedure which entails an incision in the neck and the removal of lymph nodes from around the airway. Endobronchial ultrasound (EBUS) and endoscopic ultrasound (EUS) are new, non-surgical techniques that have been available for the past several years and are proving invaluable in lung cancer evaluation. These techniques are minimally invasive and can be performed without surgery.

To date, there have been no head-to-head studies on the same group of patients using both the old and new techniques. The study will consist of a study which compares traditional staging techniques in lung cancer patients to new, less invasive techniques.

The significance of the proposed project is tremendous. If the new strategies prove to be equivalent (or superior) to traditional techniques, these techniques will be considered the new gold-standard tests. This will change the way lung cancer is evaluated. An equivalent or superior result will also significantly impact on patient care, cost and morbidity due to the speed, convenience and lack of operating room requirement as well as the lack of general anesthesia.

1. Problem:

   The gold standard techniques to stage and diagnose the mediastinum in patients with lung cancer consist of cervical mediastinoscopy (CM). CT, PET and PET-CT scans have improved the radiological staging of the mediastinum; however these techniques are unable to provide a tissue diagnosis and are inaccurate. Endobronchial ultrasound (EBUS) and endoscopic ultrasound (EUS) have been available for the past few years and are proving invaluable in the diagnosis and staging of the mediastinum. These techniques rely on imaging of mediastinal lymph nodes (LN) through the airway (EBUS) and the esophagus (EUS) using miniaturized ultrasound probes mounted on the tip of flexible bronchoscopes (EBUS) and esophagoscopes (EUS). Once a LN is visualized and identified using either of these techniques, a needle is passed through the airway (EBUS) or esophageal (EUS) wall into the LN and biopsies are performed. These minimally invasive trans-luminal techniques do not require general anesthesia and can be performed safely, rapidly, accurately and at low cost.

   Due to the cost, inconvenience and risks associated with traditional surgical mediastinal diagnosis and staging, many physicians are foregoing tissue diagnosis of the mediastinum, resulting in incomplete pre-operative staging for patients. The endoscopic techniques are quickly replacing traditional techniques in some centers; however, when replacing a gold standard test with a new modality, one must first prove equivalence in safety and efficacy. Until such a study is completed, we do not have compelling data to be able to offer these techniques as equivalent alternatives to patients. The proposed project will be the first head-to-head comparison of both endobronchial (EBUS) and endoscopic ultrasound (EUS) in addition to transluminal biopsy with gold standard invasive surgical staging techniques in the diagnosis and staging of NSCLC.
2. Objectives:

   * Define and compare the sensitivity, specificity, positive predictive value, negative predictive value, likelihood ratio and accuracies between traditional and minimally invasive mediastinal diagnostic and staging techniques for lung cancer.
   * Compare morbidity, convenience, cost and efficiencies between traditional and minimally invasive diagnostic strategies.
   * Examine the impact on decisions regarding changes in treatment plans (neoadjuvant chemoradiotherapy, prevention of thoracotomy) based on minimally invasive mediastinal staging compared to conventional staging strategies.
3. Methodology:

   The study design consists of a prospective comparison of diagnostic test findings on a consecutive case series with each subject serving as his or her own control. In order to do this, we will enroll N subjects (N=166), and will subject each of the subjects to K procedures (K=3). One of those procedures, the "traditional" one (K-1), is considered to be the gold standard for comparison. We will compare the diagnostic findings from the K-2 and K-3 alternative procedures (EBUS and EUS, respectively) with the gold standard across the N subjects. We will compare them singly and in combination with the gold standard. All patients with a new or suspected diagnosis of lung cancer will be prospectively enrolled in the study. All patients will undergo standard mediastinal staging, EBUS and EUS in the operating room, during one procedure. Patients will be included in the study if they meet one of the following criteria: (A) Lung lesion with mediastinal lymphadenopathy and/or positive PET scan in the mediastinum, (B) Lung lesion without mediastinal lymphadenopathy or positive PET scan in the mediastinum. Sample size has been calculated to be 166 patients.

   Results of traditional staging techniques will be considered as the "gold standard" tests for mediastinal diagnosis and staging. These tests will be used as the standard to which other modalities and combinations of modalities are compared. Data will be collected and analyzed as a whole (all patients with mediastinal LN sampling) and separately based on pre-biopsy diagnosis, post-biopsy diagnosis, mediastinal LN size (CT scan), LN station and PET avidity. Sensitivity, specificity, positive and negative predictive values, likelihood ratios and accuracies will be calculated and used to compare EUS and EBUS (transluminal strategy) to traditional staging, EUS to EBUS, EUS to traditional staging and EBUS to traditional staging. Subanalysis based on pre-biopsy patient and imaging (CT and PET) characteristics as well as ultrasound imaging characteristics during biopsy will be used to develop predictive models for minimally invasive mediastinal diagnosis, in order to better define patients at increased or decreased likelihood of successful diagnosis using these techniques. ROC curves will be constructed and used to discriminate results between diagnostic tests.

   The primary focus of this project and the hypothesis for which the sample size calculations were designed around is whether or not minimally invasive trans-luminal mediastinal LN biopsy is as accurate as traditional "gold standard" techniques in the diagnosis and staging of the mediastinum. Sensitivity, specificity, positive predictive value, negative predictive value and accuracy will be calculated for both strategies (minimally invasive and traditional) and compared. Receiver operating curves will be used to compare the two strategies at differing sensitivity and 1-specificity values. Relative operating characteristic curves will be used to compare the two strategies at different true positive and false positive rates. The study is estimated to be completed in three years. Sample size calculation has determined that 166 patients are required for the study. The thoracic surgery division at the CHUM estimates that accrual will be approximately 1.5 patients per week (6 patients/month).
4. Expected Results:

We expect to find that minimally invasive mediastinal LN staging and diagnosis is not only equivalent in terms of accuracy to traditional staging strategies, but is actually superior. This superiority is possible, secondary to the additional LN basins accessible via these techniques.

Minimally Invasive, Diagnosis and Staging of Lung Cancer

Minimally Invasive, Trans-Luminal Diagnosis and Staging of Lung Cancer: A Prospective Head-to-Head Comparison With Traditional Gold Standard Diagnostic Techniques

Define and compare the sensitivity, specificity, positive predictive value, negative predictive value, likelihood ratio and accuriacies between traditional and minimally invasive mediastinal diagnostic and staging techniques for lung cancer.

Compare morbidity, convenience, cost and efficiencies between traditional and minimally invasive diagnostic strategies.

Society of University Surgeons

High-risk for Pancreatic Cancer: Patients with 2 or more relatives with pancreatic cancer and a first degree relationship with at least one of the relatives with pancreatic cancer.

Ultrasound scope will be passed through the participant's mouth into their stomach and their pancreas will be evaluated completely by the ultrasound scope. If an abnormality is found in their pancreas, a biopsy may be performed to obtain a diagnosis.

Aamir Dam, M.D.

The purpose of this study is to find out whether Endoscopic Ultrasound (EUS) can detect early stage pre-cancerous or cancerous changes in the pancreas in patients at high-risk for the development of pancreatic cancer. Endoscopic refers to the use of an instrument called an endoscope - a thin, flexible tube with a tiny video camera and light on the end. Ultrasound refers to an imaging technique that uses sound waves to produce pictures. EUS in this research study is a method of combining endoscopy and ultrasound imaging to obtain high quality images of the pancreas.

Protocol for High-Risk Assessment, Screening, and Early Detection of Pancreatic Cancer

Protocol for High-Risk Assessment, Screening, and Early Detection of Pancreatic Cancer at Moffitt Cancer Center and Lehigh Valley Hospital

To determine whether targeted screening of these high-risk individuals using Endoscopic Ultrasound (EUS) at regular intervals can detect precancerous pancreas changes or early stage asymptomatic pancreatic cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Endobronchial Ultrasound (EBUS) for Nodal Staging in Esophageal Cancer	NCT01038544	Esophageal Canc...	Endoscopic Ultr... Endobronchial U...	18 Years -	Centre hospitalier de l'Université de Montréal (CHUM)
Confocal Endomicroscopy of Pancreatic InVivo	NCT01035008	Pancreatic Cyst...	Endoscopic Ultr...	18 Years -	Mayo Clinic
Cryotherapy for Malignant Dysphagia in Patients With Advanced Esophageal Cancer	NCT02606396	Esophageal Aden...	Cryotherapy Esophagogastrod... Endoscopic ultr...	18 Years -	Hunter Holmes Mcguire Veteran Affairs Medical Center
Genetic, Microenvironmental, and Immunological Factors in Unresectable Pancreatic Ductal Adenocarcinoma	NCT05248750	Pancreas Cancer		18 Years - 80 Years	Catholic University of the Sacred Heart
Genetic, Microenvironmental, and Immunological Factors in Unresectable Pancreatic Ductal Adenocarcinoma	NCT05248750	Pancreas Cancer		18 Years - 80 Years	Catholic University of the Sacred Heart
Cryotherapy for Malignant Dysphagia in Patients With Advanced Esophageal Cancer	NCT02606396	Esophageal Aden...	Cryotherapy Esophagogastrod... Endoscopic ultr...	18 Years -	Hunter Holmes Mcguire Veteran Affairs Medical Center
Endobronchial Ultrasound (EBUS) for Nodal Staging in Esophageal Cancer	NCT01038544	Esophageal Canc...	Endoscopic Ultr... Endobronchial U...	18 Years -	Centre hospitalier de l'Université de Montréal (CHUM)
Minimally Invasive, Diagnosis and Staging of Lung Cancer	NCT01011595	Lung Cancer	Cervical Medias... Endobronchial U... Endoscopic Ultr...	18 Years -	Centre hospitalier de l'Université de Montréal (CHUM)
Protocol for High-Risk Assessment, Screening, and Early Detection of Pancreatic Cancer	NCT01662609	Pancreatic Canc...	Endoscopic Ultr...	30 Years -	H. Lee Moffitt Cancer Center and Research Institute
Minimally Invasive, Diagnosis and Staging of Lung Cancer	NCT01011595	Lung Cancer	Cervical Medias... Endobronchial U... Endoscopic Ultr...	18 Years -	Centre hospitalier de l'Université de Montréal (CHUM)
Confocal Endomicroscopy of Pancreatic InVivo	NCT01035008	Pancreatic Cyst...	Endoscopic Ultr...	18 Years -	Mayo Clinic

Spots Global Cancer Trial Database for endoscopic ultrasound (eus)