Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Multiple Pulmonary Nodules

Solitary Pulmonary Nodule

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

All Drugs and Chemicals

Antibodies

Autoantibodies

Immunoglobulins

Douglas W Johnson, MD

Recent studies have shown that low-dose chest CT scans can detect lung cancers in high-risk populations (age \>50yo, \>30 pack-years of tobacco use), and can lower cancer mortality. Unfortunately, the vast majority of "positive" findings on these CT scans are benign (\>95%). Currently, an inordinate amount of expensive follow-up testing is required for these patients to try to prove who among them truly has a cancer.

Several new emerging non-invasive and potentially cheaper tests are now being investigated to help differentiate patients with cancers versus just benign lung nodules. These new tests include a new type of sputum analysis, a breath analysis, a blood test measuring certain tumor markers, a blood test looking for auto-antibodies, and a standard PET/CT scan. Each of these tests have different sensitivity and specificity rates when looking for lung cancer, and it is unclear which test is best.

This study will employ a panel of all 5 of these non-invasive tests on an initial cohort of 50 patients with recently diagnosed lung cancer to try to measure the sensitivity of the tests. A follow-on study will then perform the same panel of tests on 300 lung nodule patients to see which test, or combination of tests, gives the best overall accuracy in terms of predicting who really has lung cancer. It is hoped that the use of such a panel could lead to dramatically decreased need for expensive and morbid invasive testing for this population.

The study revolves around specifying the exact signatures and accuracy associated with discriminating between benign and malignant SPNs for each of the biomarkers in the specific high risk cohort under the NLST screening protocol. To help identify and quantify these signatures, we will evaluate specifically the volatile signature in the exhaled breath, the accuracy of LuCED sputum detection, the profile of tumor markers and the specifications of auto-antibodies through immunoassays and Orbitrap technology, and the PET/CT in patients already diagnosed with lung cancer.

Non-Invasive Biomarkers For Early Detection Of Lung Cancers

NON-INVASIVE BIOMARKERS FOR EARLY DETECTION OF LUNG CANCERS: ELEMENT 1: NON-RANDOMIZED PHASE II EVALUATION AND VALIDATION IN NEWLY DIAGNOSED LUNG CANCER PATIENTS

Douglas W. Johnson MD, FACR

Principal Investigator

Radiation -Thirty to forty (30-40) patients will receive a DR standard of care chest exam using the DRX Plus detector and a DE exam. Each DE patient exam includes high energy and low energy image exposures using the investigational device. These images are used by the DE console software to generate additional DE images (e.g. bone and soft tissue).

Radiation - Fifteen to twenty (15-20) patients will receive a DR standard of care chest exam using the DRX Plus detector, and a DT exam. Each DT patient exam includes a scout image (chest PA) and a DT scan using the investigational DT SW. The DT scan is used by the DT console software to generate tomographic images.

Radiation - Eleven (11) phantoms of various anatomy will be imaged with linear tomography (LT) as predicate and DT for investigational.

Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure. Phantoms were imaged using linear tomography and digital tomography.

Radiation

Narinder Paul, MD

The purpose of this study is to evaluate the imaging performance of Dual Energy and Digital Tomosynthesis (DE-DT) application against the commercially available predicate devices.

The acquisition system will consist of using site equipment including the CARESTREAM DRX-Evolution x-ray system, and the predicate CARESTREAM DRX Plus detector and the investigational DE-DT application.

DE Study Design Thirty to forty (30-40) patients will receive a DR standard of care chest exam using the DRX Plus detector and a DE exam. Each DE patient exam includes high energy and low energy image exposures using the investigational device. These images are used by the DE console software to generate additional DE images (e.g. bone and soft tissue).

DT Study Design Fifteen to twenty (15-20) patients will receive a DR standard of care chest exam using the DRX Plus detector, and a DT exam. Each DT patient exam includes a scout image (chest PA) and a DT scan using the investigational DT SW. The DT scan is used by the DT console software to generate tomographic images.

11 phantoms of various anatomy will be imaged with linear tomography (LT) as predicate and DT for investigational.

Clinical Evaluation of CARESTREAM Dual Energy and Digital Tomosynthesis

1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.

Carestream Health, Inc.

Radiation -Thirty to forty (30-40) patients will receive a DR standard of care chest exam using the DRX Plus detector and a DE exam. Each DE patient exam includes high energy and low energy image exposures using the investigational device. These images are used by the DE console software to generate additional DE images (e.g. bone and soft tissue).

Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure.

Predicate & Invest. DE - Human Subjects

Radiation - Fifteen to twenty (15-20) patients will receive a DR standard of care chest exam using the DRX Plus detector, and a DT exam. Each DT patient exam includes a scout image (chest PA) and a DT scan using the investigational DT SW. The DT scan is used by the DT console software to generate tomographic images.

Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure.

Predicate & Invest. DT - Human Subjects

Radiation - Eleven (11) phantoms of various anatomy will be imaged with linear tomography (LT) as predicate and DT for investigational.

Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure.

Predicate & Invest. DT - Phantom Images

Total

> 18 years

Age, Customized

unknown

Sex/Gender, Customized

37 live human DE cases, 18 live human DT cases, 11 phantom images.

Susan Pate, RN, MS, RAC, Senior Clinical Manager

224 image ratings from 7 radiologist readers (32 images rated x 7 readers) for Predicate \& Invest. DE - Human Subjects arm above.

Radlex Scale for Diagnostic Quality Ratings - DE Predicate PA Chest

Radlex Scale for Diagnostic Quality Ratings - DE Investigational Composite

Radlex Scale for Diagnostic Quality Ratings - DE Investigational High Energy

Radlex Scale for Diagnostic Quality Ratings - DE Investigational Low Energy

119 image ratings from 7 radiologist readers (17 images rated x 7 readers) for Predicate \& Invest. DT Reference 1 - PA Chest arm above.

Radlex Scale for Diagnostic Quality Ratings - DT Reference 1- PA Chest

119 image ratings from 7 radiologist readers (17 images rated x 7 readers) for Predicate \& Invest. DT Reference 2 - PA and LAT Chest arm above.

Radlex Scale for Diagnostic Quality Ratings - DT Reference 2 - PA and LAT Chest

119 image ratings from 7 radiologist readers (17 images rated x 7 readers) for DT Investigational - Scout \& DT Volume.

Radlex Scale for Diagnostic Quality Ratings - DT Investigational - Scout & DT Volume

77 phantom image ratings from 7 radiologist readers (11 images rated x 7 readers) for Predicate \& Invest. DT - Phantom Images arm above.

Radlex Scale for Diagnostic Quality Ratings - LT Predicate Phantom Images

Radlex Scale for Diagnostic Quality Ratings - DT Investigational Phantom Images

Overall Study

Digestive System Diseases

Gland and Hormone Related Diseases

Heart and Blood Diseases

Blood and Lymph Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Pancreatic Neoplasms

Aneurysm

Aortic Aneurysm

Aortic Aneurysm, Abdominal

Liver Neoplasms

Lymphadenopathy

Kidney Neoplasms

Adrenal Gland Neoplasms

Neoplasms, Adnexal and Skin Appendage

Vascular Diseases

Aortic Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Liver Diseases

Lymphatic Diseases

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Adrenal Gland Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pancreatic Cancer

The Case Group will target consenting 141 participants from the cases with indeterminate but potentially significant findings (E3/E4s) other than pulmonary nodules.

The Pulmonary Nodules Case Group will comprise 119 cases with E3/E4 ECFs characterized as pulmonary nodules.

The E1 Control Group will be drawn from the 866 E1 ECF cases from ACRIN 6664 to create a cohort of 260 E1 ECF cases. The Control Group for comparison with the Case Group and the Pulmonary Nodules Case Group will be selected at the Biostatistics and Data Management Center (BDMC). The BDMC will match E1 141 controls to the 141 case-group participants with indeterminate but potentially significant findings (E3/E4s). The BDMC will also match 119 E1 controls to the 119 E3/E4 pulmonary nodules cases. Controls will be matched by site, age caliper (5 years), and sex where possible.

Hanna M. Zafar, MD, MHS

The ACRIN 7151 trial will use medical records abstraction data from participants with extracolonic findings (ECFs) reported from the ACRIN 6664 National CT Colonography Trial to: 1) measure incidence of diagnostic imaging, hospitalization, and interventional procedures associated with ECFs reported on computed tomography colonography (CTC), delineated by type of ECF; 2) determine potential predictors of follow-up diagnostic imaging, hospitalization, and interventional procedures, delineated by type of ECF; and 3) evaluate the clinical/pathologic diagnoses associated with indeterminate but potentially significant ECFs. These data can be used to incorporate ECFs into existing models on the cost-effectiveness of CTC in colorectal cancer screening and can potentially be used to develop guidelines for the reporting and management of ECFs.

The original ACRIN 6664 National CT Colonography Trial included 15 participating sites and a total study data set of 2531 participants. The target study data set for the ACRIN 7151 trial is 520 participants, assigned to one of three cohorts: an E3/E4 Case Group (n = 141) excluding pulmonary nodules, an E3/E4 Pulmonary Nodules Case Group (n = 119), and an E1 Control Group (n = 260) (see Section 8.6). Medical records will be collected by the site from their institutions and from the primary care provider identified by the participant during the ACRIN 6664 trial. Initial record collection will comprise the six months following CTC for all cohorts. Additional medical record collection (from other primary care providers, specialists, and hospitals, and for extended time periods) may be necessary for primary endpoint determination. ECFs are categorized according to the original radiology read of the CTC during the ACRIN 6664 trial.

Extracolonic Findings on Computed Tomography (CT) Colonography

Incidence and Significance of Extracolonic Findings on CT Colonography: Retrospective Analysis of "National CT Colonography Trial" Data

Estimate the rates of follow-up diagnostic imaging, hospitalization, and interventional procedures commonly associated with ECFs within six months of receiving CTC for all three cohorts (E3/E4, pulmonary nodules, and E1). Compare the rates of medical utilization among participants with indeterminate but potentially significant ECFs (E3/E4s) and participants with pulmonary nodules, to participants with no ECFs (E1s).

Categorize the outcome of potentially clinically significant findings detected by CTC into resolved and unresolved, significant and insignificant at six-months post-examination based on medical record abstraction among participants with indeterminate but potentially clinically significant ECFs (E3/E4s) and participants with pulmonary nodules. Estimate the relationship between participant characteristics and clinically significant findings for participants with E3/E4 ECFs and participants with pulmonary nodules.

Estimate the relative risk of confirmed clinically significant findings within six months of receiving CTC among participants with indeterminate but potentially significant ECFs (E3/E4s) and participants with pulmonary nodules, compared with participants with no ECFs (E1s).

Determine potential predictors associated with increased likelihood of receiving follow-up diagnostic imaging, hospitalization, and interventional procedures within six months of receiving CTC among participants with indeterminate but potentially significant ECFs (E3/E4s), including participants with pulmonary nodules.

Estimate differences in cost associated with common expected follow-up diagnostic imaging, hospitalizations, and interventional procedures within six months of receiving CTC among participants with indeterminate but potentially significant ECFs (E3/E4s) and participants with pulmonary nodules, compared with participants with no ECFs (E1s).

American College of Radiology Imaging Network

Patients will receive an injection of indocyanine green (ICG) 1 day prior to surgery. Near infrared fluorescence imaging (NIFI) will be used to identify pulmonary nodules during the surgical biopsy and/or resection procedure.

The NIFI system will be evaluated for its ability to 1) visualize nodules and their margins 2) differentiate between benign and malignant nodules and 3) identify additional undiagnosed nodules after receiving an injection of indocyanine green 1 day prior to planned surgery.

near infrared fluorescence imaging (NIFI)

Indocyanine Green will be administered intravenously 1 day prior to NIFI.

Indocyanine Green

Inderpal Sarkaria, MD

This research study will evaluate how Near Infrared Fluorescence imaging (NIFI) with indocyanine green (ICG) contrast dye can assist in the identification and diagnosis of lung nodules during surgery. NIFI is an intraoperative imaging technology that utilizes a coupled camera/fluorophore (ICG) system to fluoresce tissues of interest. Intravenous ICG is a fluorophore with a long-standing high safety profile.

This research study is a pilot test of the effectiveness of a near infrared fluorescence imaging (NIFI) system in the detection and diagnosis of pulmonary nodules. Patients selected for enrollment in this study will be adults (≥18 years) that have been scheduled for surgical biopsy and/or resection of a primary lung nodule identified by prior imaging. Patients will receive an injection of indocyanine green (ICG) contrast dye one day prior to their surgery. Intraoperatively, the NIFI system will be used to visualize and characterize the fluorescence patterns given off by these lung nodules, as well as look for additional undiagnosed nodules. These nodules will then be resected and receive histological characterization, as per standard of care. The NIFI system will be evaluated for its ability to 1) visualize nodules and their margins 2) differentiate between benign and malignant nodules and 3) identify additional undiagnosed nodules.

Near Infrared Fluorescence Imaging With Indocyanine Green

A Pilot Trial of Near Infrared Fluorescence Imaging With Indocyanine Green in the Detection and Diagnosis of Neoplastic Pulmonary Nodules

University of Pittsburgh

Cryo biopsy

Felix JF Herth, MD, PhD

Ralf Eberhardt, MD

Felix JF Herth, MD, Phd

To proof the feasibility and safety of EBUS guided transbronchial cryo biopsies in peripheral lung lesions

Solitary pulmonary nodule are a diagnostic dilemma. Nowadays not only the basic tissue diagnosis is necessary, molecular signals are state of the art. Therefore more tissue is necessary. With a cryoprobe the amount of tissue is increased compared to the classical forceps biopsy.

Until now, the use of the cryoprobe ism´t show in peripheral lung tissue.

EBUS Guided Cryo Biopsy of Solitary Pulmonary Nodules

Number of Participants with Adverse Events as a Measure of Safety Detailed analysis of number of Pneumothoraces and number of bleeding complication

Diagnostic yield of the different biopsy techniques in establishing a specific diagnosis of the lesion

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Non-Invasive Biomarkers For Early Detection Of Lung Cancers	NCT01580332	Lung Cancer		18 Years -	Baptist Cancer Institute
Clinical Evaluation of CARESTREAM Dual Energy and Digital Tomosynthesis	NCT02531646	Solitary Pulmon...	Radiation	18 Years -	Carestream Health, Inc.
Extracolonic Findings on Computed Tomography (CT) Colonography	NCT01465425	Solitary Pulmon... Multiple Pulmon... Renal Neoplasms Adrenal Gland N... Aortic Aneurysm... Liver Neoplasms Adnexal and Ski... Lymphadenopathy Pancreatic Neop...		50 Years -	American College of Radiology Imaging Network
Near Infrared Fluorescence Imaging With Indocyanine Green	NCT02851368	Solitary Pulmon...	near infrared f... Indocyanine Gre...	18 Years -	University of Pittsburgh
Clinical Evaluation of CARESTREAM Dual Energy and Digital Tomosynthesis	NCT02531646	Solitary Pulmon...	Radiation	18 Years -	Carestream Health, Inc.
EBUS Guided Cryo Biopsy of Solitary Pulmonary Nodules	NCT01221493	Yield of Cryo B... Solitary Pulmon...	Cryo biopsy	40 Years - 80 Years	Heidelberg University
Extracolonic Findings on Computed Tomography (CT) Colonography	NCT01465425	Solitary Pulmon... Multiple Pulmon... Renal Neoplasms Adrenal Gland N... Aortic Aneurysm... Liver Neoplasms Adnexal and Ski... Lymphadenopathy Pancreatic Neop...		50 Years -	American College of Radiology Imaging Network

Spots Global Cancer Trial Database for solitary pulmonary nodules