Infections

Symptoms and General Pathology

All Conditions

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Empyema

Fibrosis

Pleural Effusion, Malignant

Pleural Effusion

Tuberculosis

Tuberculosis, Pleural

Pleurisy

Communicable Diseases

Mycobacterium Infections

Bacterial Infections

Gram-Positive Bacterial Infections

Mycoses

Bacterial Infections and Mycoses

Pleural Diseases

Respiratory Tract Diseases

Pleural Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Suppuration

Inflammation

Respiratory Tract Infections

Tuberculosis, Extrapulmonary

Shen Gwan Han, MD

Connective tissue growth factor (CTGF) is known to be a fibrogenic cytokine, it could be expressed in various fibrosis diseases. But, recent research showed that CTGF also be considered to be a tumor suppressive gene. The expression of CTGF protein is higher in normal Type I and II alveolar epithelial cells than metastatic tumor cells. CTGF appears to be a suppressor of lung tumor invasion and in metastasis and the decreased CTGF expression in tumor tissues was associated with advanced tumor stage, lymph node metastasis, early postoperative relapse and shorter patient survival.

CTGF can be expressed in many human organs such as heart, brain, placenta, liver, muscle, kidney, peritoneal mesothelial cells and lung but did not known in the pleura. The CTGF protein is present in the peritoneal cavity and is increased during peritonitis. Considering pleural cavity comes from the same origin of mesenchyma with peritoneum, pericardium and fallopian tube, we aim to evaluate whether the CTGF expression increase in the pleurisy patients including the parapneumonic effusion and the TB pleurisy.

The diagnosis of TB pleurisy depends on the effusion TB culture and pleural biopsy. Unfortunately the sensitivity of TB culture was only 20-30%. So most patients must receive invasive pleural biopsy. Adenosine deaminase(ADA) was developed as a screening test but should not be considered an alternative test to culture and biopsy. The sensitivity of ADA might vary from 32%-100% and the cutoff value also vary from 26 to 70 IU/L. We should develop a method to alternate the culture and biopsy . Therefore, our technologist Jao-Jia chu will develop the CTGF ELISA kit for this specific aim. If CGTF might increase expression in pleuritis but decrease in pleural metastasis, it might be a potential method help to differentiate lymphocytic pleural effusion between TB pleurisy and malignancy.

Connective tissue growth factor (CTGF, also known as CCN2) is a member of the CCN family. Cysteine-rich 61(Cyr61) is known as CCN1, and nephroblastoma over-expressed (Nov, known as CCN3) as well as Wisp-1/elm1( CCN4),Wisp-2/rCop1(CCN5), and Wisp-3 (CCN6)1. The CTGF is a secretory growth factor that bind with integrins on the cell surface and was first identified as a mitogen isolated from the medium of human umbilical vein endothelial cells2. CTGF can be expressed in many human organs such as heart, brain, placenta, liver, muscle, kidney, and lung and may have many biologic functions3. CTGF stimulate the proliferation of fibroblast and vascular endothelial cells. The level of CTGF protein is increased in patients with various fibrotic human disease including renal failure, hepatic fibrosis in biliary atresia, systemic scleroderma and vascular atherosclerosis4.

Recent research revealed the expression of CTGF protein was high in the normal lung epithelium and moderate to high in stage I lung adenocarcinoma cells5. But the expression of CTGF was reduced in low grade metastatic respiratory epithelial tumor cells. The CTGF expression was associated with the suppression of human lung cancer cell metastasis in a mouse model and the reduced CTGF expression was also associated with clinical metastasis and patient survival5. The expression of CTGF protein was statistically significantly higher in normal lung type I and II epithelial cells than in the majority of metastatic adenocarcinoma specimens revealed that the level of CTGF protein decreases during clinical disease when cells acquire the ability to grow at metastatic site6. CTGF appears to be a suppressor of lung tumor invasion and metastasis and the decreased CTGF expression in tumor tissues was associated with advanced tumor stage, lymph node metastasis, early postoperative relapse, and shorter patient survival. Connective tissue growth factor acts as an independent prognostic marker in colorectal cancer and giomas and inhibits metastasis7,8

Comparison the Level of CTGF Protein and Related Cytokine in Pleural Effusion

Comparison the Level of CTGF Protein and Related Cytokine in Pleural Effusion Among Tuberculous Pleurisy and Malignant Pleural Effusion Patients

Ton General Hospital

Taichung Veterans General Hospital

Blood and Lymph Conditions

Immune System Diseases

Granuloma

Lymphoproliferative Disorders

Lymphatic Diseases

Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation

Procedure performed with Conventional Computed Tomography (CT) image guidance

Cone-beam computed tomography (CT)

Conventional Computed Tomography (CT)

Bradford Wood, M.D.

Background:

- Procedures that use medical tools in or near a possible abnormality in the body often use computed tomography (CT) scans to locate the abnormality and guide the path that a needle will take to collect a sample of tissue. Xperguide and electromagnetic (EM) tracking are two new procedures being studied to help guide the needle. Xperguide is software that uses CT images to help the doctor choose the needle path. EM tracking uses special medical tools with miniature coils that act like a Global Positioning Satellite (GPS) device to show the location of the needle in the body. Xperguide and EM tracking have been used in humans and have good results, but they have not been compared with each other and regular CT to determine whether they are better than the standard approach.

Objectives:

- To compare the results of Xperguide, electromagnetic tracking, and regular computed tomography during a guided percutaneous procedure.

Eligibility:

- Individuals at least 18 years of age who are required to have a CT-guided percutaneous procedure.

Design:

* Participants will be screened with a physical examination and medical history, and the results of any previous imaging studies will be examined before study enrollment.
* After a pilot phase, the study will involve two phases to compare the results of the different procedures. The first phase will involve comparing Xperguide to CT, and the second will involve comparing Xperguide to EM tracking.
* Phase 1 participants will be assigned to one of two procedure groups: Group 1 will have Xperguide, and Group 2 will have regular CT. Participants who are scheduled to have repeated procedures (like a biopsy before and after chemotherapy) will be randomized for the first procedure and the second procedure will be done using the other method.
* Phase 2 participants will be assigned to one of two procedure groups: Group 1 will have Xperguide, and Group 2 will have EM tracking. Participants who are scheduled to have repeated procedures (like a biopsy before and after chemotherapy) will be randomized for the first procedure and the second procedure will be done using the other method.
* Standard post-procedure followup care will be given after the study procedure is completed.

PR(SqrRoot) CIS

This is a phase II prospective randomized trial comparing a novel navigation method, Xperguide to conventional CT and electromagnetic tracking (EM) during percutaneous image guided procedures. Xperguide is a navigation tool that utilizes a cone beam CT (CBCT) obtained in the angiography suite overlaid on fluoroscopy for needle guidance during image guided procedures. The needle entry point and path are planned on the CBCT and the determined path is overlaid on fluoroscopy image for real time guidance.

SPECIFIC AIMS/OBJECTIVES

1. The primary aims are:

   a. Pilot trial:

   i. To familiarize operators with outcome measures allowing for fair comparison in the subsequent study

   b. Main trial will have 2 phases with similar outcomes criteria and aims (below):

   i. comparing Xperguide to conventional imaging (superiority design):

ii. comparing Xperguide to EM tracking (equivalence design):

1. To compare the accuracy of final device tip position and path (vector)
2. To compare the number of repositioning maneuvers
3. To compare the radiation dose
4. To compare rates of definitive pathological diagnosis and response rate per EASL criteria for ablations

METHODS/METHODOLOGY

For non-vascular image guided interventions, patients undergoing biopsies and ablations procedures requiring CT guidance are eligible for inclusion and randomization. An initial pilot study will be done in which each operator will perform at least 5 cases using Xperguide completing the case report forms. This will ensure experience with outcome measures and fair comparison in the subsequent study. Once one of the operators reaches the minimal required cases, the main trial will begin for that operator. However every other operator must each complete the minimal number of cases with the case report forms to enroll patients in the main trial. Initially, we will compare Xperguide with conventional CT with several cohorts of patients mainly: lung biopsies, and ablations, kidney biopsies/ablations and other abdominal biopsies/ ablations. In ablations of large lesions, Xperguide composite ablation software can provide input on the expected ablation zones. Each probe will be positioned in the same manner as any biopsy needle following steps described in section 4. If this specific composite ablation module of the

software is not commercially released and FDA cleared at the time of the study, then this software will only be used on protocol to help the physician determine ideal needle positioning for complete ablation. Once consent is obtained the participant is randomized to either conventional imaging or Xperguide. In addition, if it is known that the patient is participating in a trial which requires a repeat (paired, pre and post treatment) procedure of the same site, then the randomization will determine which modality is used for guidance at the first visit and the other modality will automatically be used for the second procedure. In these cases, if the patient gives consent they will be randomized to one of two categories:

1. Xperguide for the initial procedure and conventional CT for the 2nd procedure
2. Conventional CT for the initial procedure and Xperguide for the 2nd procedure

Then in the second phase of the trial, Xperguide will be compared to EM tracking for biopsies and ablations requiring CT guidance, in an equivalence study. Once consent is obtained, the participant will be randomized into EM tracking or Xperguide. The patients would be divided into different cohorts depending on the anatomic site of the interventions i.e. lung, kidney, liver and other abdomen. If the patients are participating in a trial requiring paired procedures (i.e. pre and post treatment), the randomization will determine which modality is used for the initial procedure and the other modality will be used for the second procedure. In summary there will be two potential categories:

1. EM tracking for the initial procedure and Xperguide for the 2nd procedure
2. Xperguide for the initial procedure and EM tracking for the 2nd procedure

If a patient has a lesion that is only visible on PET-CT/MR, or demonstrates heterogenous PET-CT/MR uptake, there will be a separate cohort of PET-CT/MR guided biopsies and ablations using Xperguide vs EM tracking. There is also the need for a cohort for ablations with complimentary use of ultrasound at the discretion of the operator in order to conform to our standard of care at the NIH.

ELIGIBILITY

Subjects are eligible if:

1. they are over 18 years of age
2. they are scheduled for image guided procedure
3. the lesion is not superficial (deeper than 3cm)

Subjects are excluded if:

1. they have an altered mental status that precludes understanding or consenting for the procedure
2. they are unable to hold reasonably still on a procedure table for the length of the procedure
3. they are unable to hold their breath if the procedure will be performed with conscious sedation and without general anesthesia
4. their gross body weight is over 375 pounds which the upper limit of the CT and

angiography tables

REQUIRED SAMPLE SIZE

A pilot study will be performed to ensure operator experience with Xperguide and EM tracking, for fair comparison. In the pilot study each operator must perform 5 cases with Xperguide completing the case report forms. There are 5 potential operators therefore a maximum of 25 patients (if all 5 operators participate to the fullest).

The first phase of the main trial comparing Xperguide with conventional CT was powered (for sample size) with a standard superiority design aimed to statistically establish that Xperguide is better than conventional CT (defined as requiring fewer needle repositioning efforts). These calculations yield a total sample size of 60 patients with 20 patients per anatomical site.

For the second phase of the trial comparing Xperguide to EM tracking, a two sided equivalence design (based on accuracy and number of needle repositioning) was used for sample size considerations, and yielded 192 patients. Therefore 16 patients per modality per anatomical site will be randomized with two additional cohorts for PET-CT/MR procedures and composite ablations.

Number of Participants: 277

Recruitment Time Frame: 4 years

Number of sites: 1

Type of Study: prospective randomized clinical trial after an initial pilot period

Comparing Xperguide vs. Conventional Methods During Percutaneous Image Guided Procedures

Prospective Randomized Trial Comparing Navigation With Xperguide vs. Conventional Methods During Percutaneous Image Guided Procedures

To compare the accuracy of the biopsy needle between the software guidance and conventional CT. The accuracy of the needle position was calculated in millimeters by using the difference between the x,y,z coordinates of the tip of the actual needle before specimen collection. Actual and planned needle paths were compared using coordinates and measured in millimeters.

Comparing the accuracy of the path the biopsy needle took to get to the site

Comparing radiation doses to determine if there is a change in the dose between the two interventions

To compare the number of times the needle must be repositioned during the guidance of the needle to the biopsy.

Definitive pathologic diagnosis was defined as an adequate specimen as judged by the pathologist and a diagnosis confirmed by surgery or clinical follow-up.

National Institutes of Health Clinical Center (CC)

Cone Beam CT

Conventional CT

Pilot participants were enrolled to familiarize operators with performing Xperguide procedures.

Pilot Arm

Procedures performed with Xperguide without randomization to familiarize operators.

PILOT

Total

Age, Categorical

Sex: Female, Male

Bradford Wood, MD

Participants enrolled in the PILOT Arm were not randomized to the Cone Beam CT or Conventional CT Arms and were not included in the analysis. PILOT Participants were enrolled to familiarize operators with performing Xperguide procedures.

Comparing the Accuracy of Final Device Tip Position

Convetional CT

Accuracy of Final Device Path (Vector)

Radiation Doses Between Xperguide and Conventional CT

Compare the Number of Repositioning Maneuvers

Rates of Definitive Pathologic Diagnosis

Overall Study

Skin and Connective Tissue Diseases

Lung Neoplasms

Breast Neoplasms

Any subject who has pleural fluid buildup from lung cancer, breast cancer, or lung infection

Carmmen Garcia

Luz Cuaboy

Jason Akulian, MD

Jason Akulian

Research with biospecimens such as blood, tissue, or body fluids can help researchers understand how the human body works. Researchers can make new tests to find diseases, understand how treatments work, or find new ways to treat a disease. The purpose of this study is to collect biospecimens for research from patients with known or suspected lung cancer. The information learned from the biospecimens may be used in future treatments. The purpose of this protocol is to create a pleural fluid registry for use in future studies.

UNC Pleural Fluid Registry

University of North Carolina Pleural Fluid Registry

There is no plan to share IPD with other researchers.

Biological specimens and corresponding clinical data from subjects will be collected during standard of care procedures and medical record abstraction to support the creation of a pleural fluid registry.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison the Level of CTGF Protein and Related Cytokine in Pleural Effusion	NCT00313066	Tuberculosis Tuberculous Ple... Malignant Pleur... Empyema		18 Years -	Taichung Veterans General Hospital
Comparing Xperguide vs. Conventional Methods During Percutaneous Image Guided Procedures	NCT01287013	Infection Cancer Neoplasm Empyema Granuloma	Cone-beam compu... Conventional Co...	18 Years - 100 Years	National Institutes of Health Clinical Center (CC)
UNC Pleural Fluid Registry	NCT05620329	Lung Cancer Lung Infection Breast Cancer Malignant Pleur... Empyema		18 Years -	UNC Lineberger Comprehensive Cancer Center
UNC Pleural Fluid Registry	NCT05620329	Lung Cancer Lung Infection Breast Cancer Malignant Pleur... Empyema		18 Years -	UNC Lineberger Comprehensive Cancer Center

Spots Global Cancer Trial Database for empyema

Every month we try and update this database with for empyema 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 empyema

Every month we try and update this database with for empyema 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 empyema 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.