Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Infections

Wounds and Injuries

Symptoms and General Pathology

Breast Neoplasms

Lung Neoplasms

Pneumonia

Radiation Pneumonitis

Communicable Diseases

Respiratory Tract Infections

Lung Diseases

Respiratory Tract Diseases

Lung Diseases, Interstitial

Lung Injury

Radiation Injuries

High fidelity functional lung imaging (HFFLI) is an improved method of measuring pulmonary function by analyzing 3-Dimensional (3D) motion. Using this technique, we are able to detect and localize pathological changes in the lung with sub-segmental resolution. The approach uses a unique cross-correlation analysis and non-linear optimization to reconstruct lung tissue motion from a small number of standard projections. All participants will undergo standard 4D Computed Tomography (CT), standard Cone Beam CT, research Low-dose Cinefluorography, and additional research Pulmonary Function Tests.

The initial 4DCT imaging obtained as part of a subject's planning CT for their standard radiation treatment.

4D Computed Tomography (CT)

Daily cone beam CT imaging at each radiation treatment visit, as part of standard care

Cone Beam CT

A series of images consisting of five six-second cinefluorographs (real time fluoroscopic movies, for a total each time of 30 seconds of fluoroscopy) of the lungs while the subject is breathing, each at precisely measured angles to the subject, on 4 different occasions.

Low-dose Cinefluorography

Pulmonary Function Testing (PFT) gives global functional data for the lungs as a whole, but is relatively insensitive to early pathological changes. It involves taking very deep breaths and exhaling as forcefully as possible.

Research PFTs will be conducted at 4 and 12-months post radiation therapy

Pulmonary Function Tests

Stephen Shiao

Karen Kearns

Stephen Shiao, MD, PhD

The purpose of this study is to to compare lung function data generated by applying High Fidelity Functional Lung Imaging (HFFLI) software to 4D CT, cone beam CT, and fluoroscopic images of the lungs breathing to determine whether different modalities of imaging provide similar data on lung movement and function. HFFLI may detect changes in lung function in patients undergoing External Beam Radiotherapy for cancer.

This study is designed to test a novel technology to examine early changes in the lung in hopes of identifying patients who may be at risk for radiation pneumonitis. Eligible subjects will undergo standard of care treatment with the use of the Varian TrueBeam system for radiation therapy of a cancer lesion in the chest. The imaging data acquired as part of usual standard of care for these patients is a pre-treatment 4D planning CT scan, and a daily cone beam CT at each radiation treatment visit. We will also obtain a series of images consisting of five six-second cinefluorographs (real time fluoroscopic movies, for a total each time of 30 seconds of fluoroscopy) of the lungs while the subject is breathing, each at precisely measured angles to the subject, on 4 different occasions. This study will compare lung function data generated by applying High Fidelity Functional Lung Imaging (HFFLI) software to 4D CT, cone beam CT, and fluoroscopic images of the lungs breathing to determine the degree of correlation between data generated from different imaging modalities. The study is open to adults over the age of 18, at any stage of cancer.

Novel Lung Imaging in Adults Undergoing Radiation Therapy to Assess for Radiation Pneumonitis

Novel High Fidelity Functional Lung Imaging in Adults Undergoing Radiation Therapy to Assess for Radiation Pneumonitis

As part of standard care, patients will have a cone beam CT on each day they receive radiation treatment. Treatment period varies.

Cedars-Sinai Medical Center

Assistant Professor

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Hodgkin Disease

Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hodgkin Lymphoma

Lymphosarcoma

Antineoplastic Agents

All Drugs and Chemicals

Bleomycin

Carbon Monoxide

Tests include; total lung capacity, vital capacity, functional residual capacity, forced vital capacity, forced expiratory volume in 1 second, carbon monoxide diffusing capacity, pulse oximetry before and after a 6 minute walk and Pulmonary Status and Dyspnea Questionnaire

Obtained at different time points during the study depending upon standard of care chemotherapy treatment

CAT Scan

Andrea K. Ng, MD, MPH

The purpose of this study is to find out the impact Bleomycin-containing chemotherapy, given with or without chest radiation therapy, on patients' lung function over time.

* The tests and procedures in this study are part of regular cancer care but this study offers more structured timing of these standard tests.
* Due to the potential lung toxicity associated with bleomycin-based chemotherapy, pulmonary function tests are routinely performed. Pulmonary function tests will be performed by a licensed, registered respiratory therapist and performed prior to the beginning of treatment, between the chemotherapy and radiation therapy (only for patients receiving both chemotherapy and radiation therapy), and at approximately 1 month, 6 months, 1 year and 2 years after the completion of all treatments.
* A CAT scan will be performed prior to the beginning of treatment, and approximately 1 month, 6 months, 1 year and 2 years after the completion of all treatments.
* A self-administered questionnaire will be performed on the days the patient is undergoing pulmonary function tests.

Pulmonary Function in Patients With Hodgkin's Disease Receiving Bleomycin-Based Chemotherapy

A Prospective Study of Pulmonary Function in Patients With Hodgkin's Disease Receiving Bleomycin-Based Chemotherapy With or Without Mediastinal Irradiation

Brigham and Women's Hospital

Dana-Farber Cancer Institute

Principal Investigator

Respiratory Tract Neoplasms

Thoracic Neoplasms

analysis of lung volume and diffusion capacity

Pulmonary function tests

assess the consequences of low doses of radiation delivered by the volumetric radiotherapy, on the respiratory capacity of patients treated for bronchopulmonary carcinoma, by a follow up of functional respiratory exploration.

Radiation therapy with or without chemotherapy is a stable treatment in the management of patients with localized smack cell bronchopulmonary cancers, or not to small cells not metastatic but not operable. Radiation therapy results in changes in respiratory function, as measured by respiratory function tests and represented primarily by spirometry, total body plethysmography, and the diffusion capacity of the alveolar-capillary membrane.

Although these tests are minimally invasive, few studies have investigated the implications of radiation therapy on lung function in patients treated for pulmonary neoplasia, while these patients are often already carriers of respiratory diseases and will receive further chemotherapy during their illness, subject to their general good condition, including respiratory. No method has been recognized as superior for measuring the consequences of radiation therapy on respiratory function. After chest radiotherapy alone, the decline in diffusion capacity is estimated at 10-34%. New irradiation techniques have emerged over the last decade, in particular dynamic arc therapy. This innovative technology, combined with image-guided irradiation processes, ensures high-precision, short-term treatment, but exposes virtually all of the lungs to irradiation, although at very low doses, the objective consequences of which on respiratory functional explorations have never been reported.

The aim of this study is therefore to assess the consequences of low doses of radiation delivered by this recent technology, volumetric therapy, on the respiratory capacity of patients treated with radiotherapy within the framework of of bronchopulmonary carcinoma.

Follow-up of Pulmonary Radiotoxicity for Bronchopulmonary Cancer.

Follow-up of Pulmonary Toxicity by Respiratory Functional Tests of Patients Treated With Dynamic Cancer ARCtherapy for Bronchopulmonary Cancer.

All collected data that underlie results in a publication

diminution of 20% or more of the diffusion capacity at 3 months

University Hospital, Brest

Dimercaprol

Chelating Agents

These high-risk subjects will undergo screening for lung cancer. All subjects will undergo all listed interventions

This is a collection of sputum (mucous) you cough up. Three morning samples will be collected at one time. Sputum will be collected at baseline, year 1, year 2 and year 5.

Sputum sample

A series of different breathing tests designed to measure lung function and to determine the presence or absence of chronic obstructive pulmonary disease will be performed at baseline.

A CT scan uses x-rays to take detailed pictures of the chest. Performed at baseline, year 2 and year 5. If nodules are present, CT scans will be performed every 3 months for the first year of the study.

Computerized tomography (CT) scan of the chest

Collect cells from the inside of the cheek. Samples will be collected at baseline and yearly to year 5.

Buccal epithelium collection

A cytobrush is used to remove cells on the surface of the inside of the nose. Samples will be collected at baseline and yearly to year 5.

Nasal brushings

A flexible tube with a light and a camera will be inserted through the nose or mouth, and into the lungs to look at the airway. Bronchial tissue will be obtained.

Bronchoscopy

During a bronchoscopy, a flexible tube with a light and a camera is passed through the mouth or nose into the lungs and fluid is squirted into a small part of the lung and collected for examination. Bronchoscopies will be performed at baseline and at year 5.

Bronchoalveolar lavage

A venous blood sample will be collected for testing of biomarkers and other relevant tests. Blood will be taken at baseline and yearly to year 5.

Blood sample collection

Urine will be collected for routine urine tests at baseline and yearly to year 5.

Urine sample

A questionnaire about the patient's health, medical, and smoking history. Administered at baseline and yearly to year 5. Data will be taken from patient interviews and from the medical record.

Questionnaire-data collection

Eric Grogan, MD

This screening study will address the lack of molecular strategies for the early detection of lung cancer and integrate those with epidemiological and imaging strategies.

The hypothesis is that the repeated measure of biomarkers of risk obtained from the molecular analysis of biological specimens including those from bronchoscopy (bronchial brushings and biopsies) may contribute to the refinement of high-risk populations and allow an earlier clinical diagnosis.

The goal of the investigators study is to provide screening for lung cancer in a high-risk population. In this prospective cohort it will be tested whether repeated measure of biomarkers of risk allows early detection of lung cancer.

It is proposed to test the hypotheses in a screening study of high risk individuals (characterized by an established prediction rule). The expected prevalence of lung cancer in this high risk group is estimated to be 2% per year. All individuals benefit from clinic visit, low-dose Chest CT, spirometry and auto-fluorescence bronchoscopy at baseline, Chest CT, follow-up doctor visit, and auto-fluorescence bronchoscopy at least at year 2 and 5.

Sputum, Blood, Urine, Nasal brushings, Buccal cells, Bronchical washings, Bronchioalveolar lavage brushings, Endobronchial biopsies

Nashville Early Diagnosis Lung Cancer Project

Blood, sputum, urine, nasal washings, buccal epithelium, endobronchial tissue, and bronchioalveolar washings are examined for biomarkers present in patients who develop lung cancer compared with those patients who do not develop lung cancer. Baseline and yearly screening results will be compared in the two groups.

Blood, sputum, urine, nasal washings, buccal epithelium, endobronchial tissue, and bronchioalveolar washings are examined for presently unknown biomarkers that occur in patients with lung cancer and in patients who do not have lung cancer but who may be at further increased risk of lung cancer.

Endobronchial tissue will be examined under a microscope for presence of changes in the cells that are abnormal but which are not invasive cancer.

Inclusion criteria for those patients who, based on their biomarker profile, are at increased risk of invasive lung cancer and who may benefit from clinical trials that will study chemoprevention strategies for lung cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Novel Lung Imaging in Adults Undergoing Radiation Therapy to Assess for Radiation Pneumonitis	NCT02735746	Lung Cancer Breast Cancer Mediastinum Les... Radiation Pneum...	4D Computed Tom... Cone Beam CT Low-dose Cinefl... Pulmonary Funct...	18 Years -	Cedars-Sinai Medical Center
Pulmonary Function in Patients With Hodgkin's Disease Receiving Bleomycin-Based Chemotherapy	NCT00165438	Hodgkin's Disea...	Pulmonary Funct... CAT Scan	18 Years -	Dana-Farber Cancer Institute
Follow-up of Pulmonary Radiotoxicity for Bronchopulmonary Cancer.	NCT03931356	Cancer, Lung Radiotherapy; C...	Pulmonary funct...	18 Years -	University Hospital, Brest
Novel Lung Imaging in Adults Undergoing Radiation Therapy to Assess for Radiation Pneumonitis	NCT02735746	Lung Cancer Breast Cancer Mediastinum Les... Radiation Pneum...	4D Computed Tom... Cone Beam CT Low-dose Cinefl... Pulmonary Funct...	18 Years -	Cedars-Sinai Medical Center
Novel Lung Imaging in Adults Undergoing Radiation Therapy to Assess for Radiation Pneumonitis	NCT02735746	Lung Cancer Breast Cancer Mediastinum Les... Radiation Pneum...	4D Computed Tom... Cone Beam CT Low-dose Cinefl... Pulmonary Funct...	18 Years -	Cedars-Sinai Medical Center
Pulmonary Function in Patients With Hodgkin's Disease Receiving Bleomycin-Based Chemotherapy	NCT00165438	Hodgkin's Disea...	Pulmonary Funct... CAT Scan	18 Years -	Dana-Farber Cancer Institute
Nashville Early Diagnosis Lung Cancer Project	NCT01475500	Lung Cancer	Sputum sample Pulmonary funct... Computerized to... Buccal epitheli... Nasal brushings Bronchoscopy Bronchoalveolar... Blood sample co... Urine sample Questionnaire-d...	55 Years - 80 Years	Vanderbilt-Ingram Cancer Center
Pulmonary Function in Patients With Hodgkin's Disease Receiving Bleomycin-Based Chemotherapy	NCT00165438	Hodgkin's Disea...	Pulmonary Funct... CAT Scan	18 Years -	Dana-Farber Cancer Institute

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