Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Multiple Pulmonary Nodules

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

All Drugs and Chemicals

Anti-Infective Agents

Amino Acids

Fluorides

Fluorodeoxyglucose F18

Deoxyglucose

Radiopharmaceuticals

Protective Agents

Antimetabolites

Antiviral Agents

Glutamic Acid

Patients receive 18F-FSPG IV and, undergo a PET/CT scan over 30-60 minutes. Within 24 hours-14 days, patients receive 18F-FDG IV and undergo a second PET/CT scan over 30-60 minutes.

Computed Tomography

Fludeoxyglucose F-18

Fluorine F 18 L-glutamate Derivative BAY94-9392

Positron Emission Tomography

Mahima Goel

Carina M Aparici, MD

Carina M Aparici

This phase II trial studies how well 18F-FSPG positron emission tomography (PET)/computed tomography (CT) work in diagnosing early lung cancer in patients with lung nodules. PET imaging with an imaging agent called 18F-FDG is often used in combination with a PET/CT scanner to evaluate cancers. Giving 18F-FSPG before a PET/CT scan may work better in helping researchers diagnose early lung cancer in patients with lung nodules.

PRIMARY OBJECTIVES:

I. Comparison of fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) accumulation with fludeoxyglucose F-18 (18F-FDG) accumulation to assess whether (4S)-4-(3-18F-Fluoropropyl)-L-Glutamate (18F-FSPG)-PET is better at discriminating between benign and malignant nodules.

SECONDARY OBJECTIVES:

I. To develop and validate early lung cancer detection biomarkers that would directly impact the growing need to integrate imaging and non-invasive molecular diagnostics for indeterminate pulmonary nodules and allow physicians to avoid unnecessary invasive procedures in patients with benign lung disease.

OUTLINE:

Patients receive 18F-FSPG intravenously (IV) and, undergo a PET/CT scan over 30-60 minutes. Within 24 hours-14 days, patients receive 18F-FDG and undergo a second PET/CT scan over 30-60 minutes.

After completion of study, patients are followed up within 24-72 hours.

18F-FSPG PET/CT in Diagnosing Early Lung Cancer in Patients With Lung Nodules

18F-FSPG PET/CT and Integrated Biomarkers for Early Lung Cancer Detection in Patients With Indeterminate Pulmonary Nodules

18F-FSPG accumulation in lung nodules will be assessed. The observed FSPG specificity will be assessed against a fixed value of 75%.

Improved performance is defined as a p \< 0.05 increase in the C statistic determined using DeLong test for correlated receiver operating characteristic (ROC) curves.

Canary Foundation

Boston University

Andrei Iagaru

Associate Professor of Radiology (Nuclear Medicine)

Symptoms and General Pathology

Carcinoma, Non-Small-Cell Lung

Recurrence

Head and Neck Neoplasms

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Patients with Head and Neck or Non-Small Cell Lung Cancer who are Current or Former Smokers.

At Months 6, 12, 18, 24, 30, and 36, complete medical history will be recorded, and a physical exam will be performed by either a doctor or a nurse. At each of these visits, blood will be drawn for routine tests (about 3 teaspoons) and for research purposes (about 4 teaspoons). Also, a chest x-ray and a chest CT will be done at these visits.

Assessments

George Simon, MD

The goal of this research study is to look at how long individuals who have been treated for early stage NSCLC or HNSCC live without developing lung cancer. Another goal is to develop tools to help predict the likelihood of lung cancer occurrence in this population. This will be done by studying characteristics of tissue and bodily fluids (including blood).

Objectives:

* To assess the smoking-related disease-free survival in patients who are current or former smokers with a prior definitively-treated stage I/II lung or head and neck cancer.
* To develop a risk model to help predict the likelihood of lung cancer development both imaging and biomarker based in this high-risk population.

This study is known as the Vanguard Trial. When you enter this study, you will have a complete medical history (including smoking history) and physical exam, including measurement of height, weight, and vital signs (including blood pressure, heart rate, and temperature). You will have a performance status evaluation (a test looking at the ability to perform every day activities). You will have blood samples drawn for routine blood tests (about 3 teaspoons), to check your blood clotting function (about 1-2 teaspoons), and for research purposes (about 4 teaspoons). You will have a chest x-ray and a CT scan of your chest. Women who are able to have children must have a negative blood or urine pregnancy test. If you are currently a smoker, you will be given information on programs to help you quit smoking. Although you will be encouraged to quit smoking, you do not have to quit smoking or participate in these programs to be a part of this study.

You will also have a bronchoscopy (tissue sample from the lung) at the beginning of this study for lab analysis. For this procedure, you will be given drugs to relax. Then, a local anesthetic will be sprayed in your nose and throat to numb those areas. A slim, flexible tube with a light will be placed through your nose or mouth and into your lungs. Tweezers will be fed through the tube to collect lung tissue (biopsy) samples from 6 different places in your lungs. During the bronchoscopy procedure, a complete inspection of the airways will be performed. Any suspicious areas that are seen under the white-light and autofluorescence bronchoscopy will be identified and more biopsies and brushings will be performed to evaluate whether any pre-cancerous tissue is present. You will also have a bronchial brushing next to each biopsy site. In a bronchial brushing, a small brush is fed through the tube into your lungs and a sample of lung tissue is gently scraped off. When the biopsies and brushings are done, you will have a bronchial lavage (bronchial washing). In the bronchial lavage, a small amount of water (about 4 tablespoons) is sprayed into your lungs and then suctioned out through the tube. This fluid is used to collect additional tissue and mucous samples. In addition, a sputum (saliva) sample will be taken and the inside of your cheek will be scraped (buccal sample).

If you have had HNSCC, you will also have a laryngoscopy. In a laryngoscopy, a lighted tube is placed down your throat and the larynx is checked. The back of your throat will be sprayed with an anesthetic before this procedure to make the procedure more comfortable.

While on study, you will return to the clinic for at least 3 years and for up to a total of 6 years. At Months 6, 12, 18, 24, 30, and 36, your complete medical history will be recorded, and you will have a physical exam by either a doctor or a nurse. At each of these visits, you will also have blood drawn for routine tests (about 3 teaspoons) and for research purposes (about 4 teaspoons). You will also have a chest x-ray and a chest CT at these visits. At Months 12, 24 and 36, you will have blood drawn (about 1-2 teaspoons) to check your blood-clotting function. If you think you may be pregnant, you will also have a urine or blood pregnancy test. In addition, you will have a bronchoscopy and provide sputum and buccal smear samples at your 12 month visit. If you have been treated for HNSCC you will have a laryngoscopy at 12 months.

You have the right to leave the study at any time. If you choose to stop participating in this study, you will be asked to return to the clinic for a final clinic visit. At this visit, your complete medical history will be recorded, and you will have a physical exam and blood drawn for routine tests (about 3 teaspoons) and for research purposes (about 4 teaspoons). Your study doctor will also ask you about your current smoking use, any medications you are taking, and how you are feeling (symptoms).

This research study includes two bronchoscopies done one year apart. These bronchoscopies are being done primarily for research purposes and are unlikely to provide information useful in your individual treatment. These bronchoscopies do have risks associated with them. These risks are described in section 4 of this informed consent document.

Recent research on early stage NSCLC indicates that adjuvant chemotherapy after surgery increases the length of time a person may survive and the length of time before cancer recurs. However, this adjuvant chemotherapy also has side effects that can be severe and in rare cases fatal. If you have had surgery for NSCLC and wish to receive adjuvant chemotherapy, you may only enroll in the Vanguard study after you have completed the adjuvant chemotherapy.

As part of this study you will provide samples of your lung tissue, saliva, blood, and scrapings from the inside of your cheek. Fluid and mucous collected during the bronchoscopies will also collected. These samples will be studied by scientists to learn about genes and proteins in people who have been treated for early NSCLC or HNSCC. The samples will also be used to grow cells and cultures that will be used to test chemotherapy drugs. These cells and cultures will also be used to learn about genes and proteins.

All M. D. Anderson researchers are trained in the importance of maintaining patient privacy. Your privacy will be protected by assigning you a number that will be used in place of your name on documents that are part of this study. A list that links your name with your study number will be stored in a restricted file that may be accessed only with a password. Only a few essential research personnel have access to this password.

At the end of the study you will not be automatically notified of the research findings. If you wish to learn about the results, however, you may request them from the principal investigator:

Principal Investigator: Waun Ki Hong, MD 1515 Holcombe Blvd., Unit 432 MD Anderson Cancer Center Houston, TX 77030

This is an investigational study. A total of about 50 individuals will take part in this study. Participants will be enrolled at M. D. Anderson and several other sites around the country.

Samples of lung tissue, saliva, blood, and scrapings from inside of cheek. Fluid and mucous collected during bronchoscopies.

Vanguard Study for Head and Neck Cancer or Non-Small Cell Lung Cancer (NSCLC) Patients

Vanguard Study Characterizing Occurrence of Recurrent or Second Primary Tumors in Patients With Prior History of Definitively Treated Stage I/II Head and Neck or Non-Small Cell Lung Cancer Who Are Current or Former Smokers

Smoking-related disease-free survival (S-DFS) defined as time from registration to the development of recurrence, smoking related SPT, or disease-specific death, whichever occurs first.

United States Department of Defense

M.D. Anderson Cancer Center

Substance Related Disorders

Behaviors and Mental Disorders

Tobacco Use Disorder

Substance-Related Disorders

Chemically-Induced Disorders

Mental Disorders

Psychotic Disorders

Antipyretics

Anti-Inflammatory Agents

Antirheumatic Agents

Fibrinolytic Agents

Analgesics

Platelet Aggregation Inhibitors

Aspirin

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Patients receive acetylsalicylic acid PO QD for 12 months.

Patients receive placebo PO QD for 12 months.

Laboratory Biomarker Analysis

Placebo

Bernardo Bonanni

This randomized phase II trial studies acetylsalicylic acid compared to placebo in treating high-risk patients with subsolid lung nodules. A nodule is a growth or lump that may be malignant (cancer) or benign (not cancer). Chemoprevention is the use of drugs to keep cancer from forming or coming back. The use of acetylsalicylic acid may keep cancer from forming in patients with subsolid lung nodules.

PRIMARY OBJECTIVES:

I. The evaluation of the effect of aspirin (acetylsalicylic acid) as a chemopreventive agent for lung cancer.

SECONDARY OBJECTIVES:

I. The modulation of biological markers after treatment and the correlation of these findings with modification of lung nodules diameters.

II. The per-lesion analysis including the evaluation of lung nodule density before and after treatment, the number and size of non target lesions including solid nodules and evaluation of response according to modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive acetylsalicylic acid orally (PO) once daily (QD) for 12 months.

ARM II: Patients receive placebo PO QD for 12 months.

After completion of study treatment, patients are followed up for 1 month.

Acetylsalicylic Acid Compared to Placebo in Treating High-Risk Patients With Subsolid Lung Nodules

A Randomized Phase II Trial of Low Dose Aspirin Versus Placebo in High-Risk Individuals With CT-Detected Subsolid Lung Nodules

Difference (12 month-baseline) in the sum of longest diameters of baseline target nodules.

Difference (12 month-baseline) in the sum of baseline target nodules diameters

Difference (12 month-baseline) in lesion volume

Difference (12 month-baseline) in lesion density

Difference (12 month-baseline) in biomarker concentration

Difference (12 month-baseline) of the score on a scale (scale from -20 to +30 which measure the risk of lung cancer. Higher values indicate higher risk. A value\<0 is considered negative, a value ≥0 positive for lung cancer).

National Cancer Institute (NCI)

1 tablet of aspirin 100 mg a day for one year

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

United States

Italy

Region of Enrollment

Sum of longest diameters of baseline target nodules

Sum of diameters of baseline target nodules

Baseline lesion volume

Baseline lesion density

Scale from -20 to +30 which measure the risk of lung cancer. Higher values indicate higher risk. A value\<0 is considered negative, a value ≥0 positive for lung cancer.

Circulating biomarkers and miRNA risk score

Circulating Thromboxane

Circulating Prostaglandin E metabolite (PGEM) normalized to uCr concentration

Circulating Leukotriene E4 normalized to uCr concentration

Circulating High sensitive CRP

Dr. Therese Bevers / Clinical Cancer Prevention Department

Change in the Sum of Longest Diameters of Baseline Target Nodules (Person-specific Analysis)

Change in the Sum of Baseline Target Nodules Diameters (Per Nodules Analysis)

Change in Lesion Volume

Change in Lesion Density

Modulation of Thromboxane B2

Modulation of Prostaglandin E Metabolites (Normalized to Urinary Creatinine Concentration)

Modulation of Leukotriene E4 (Normalized to Urinary Creatinine Concentration)

Modulation of High Sensitive CRP

Modulation of miRNA Prediction Risk Score

Overall Study

This study is an observational study. There is no intervention.

Biomarker (not used as an intervention)

Duncan Whitney, PhD

The purpose of the research study is to develop a new, more sensitive, and less invasive test for diagnosing lung cancer at an earlier stage, when it can more easily be cured. The investigators hypothesize that certain genes are expressed differently in current and former smokers who have lung cancer, and this difference in gene expression may be a biomarker for lung cancer.

Allegro Diagnostics is funding this multi-center study to validate and extend a new diagnostic tool measuring global gene expression in airway epithelial cells obtained at routine bronchoscopy in suspect lung cancer patients. The test, which is highly sensitive and specific for lung cancer, measures the levels of expression of genes in cells brushed from the large bronchi during diagnostic bronchoscopy. Similar brushings of epithelial cells from the nose will be analyzed to determine if gene expression in these cells can be used as a screening tool in subjects who may have now or be at risk for developing lung cancer in the future.

Airway Epithelium Gene Expression: AEGIS IDE

Airway Epithelium Gene Expression in the Diagnosis of Lung Cancer: AEGIS IDE

Patients may be followed at 12 months post bronchoscopy to finalize diagnosis if diagnosis had not previously been confirmed. The biomarker score will be compared to the standard diagnosis to evaluate the sensitivity, specificity, and negative predictive values of the biomarker.

University of Pennsylvania

Columbia University

Temple University

Indiana University

University of Alabama at Birmingham

University of Missouri-Columbia

Louisiana State University Health Sciences Center in New Orleans

University of Wisconsin, Madison

Medical University of South Carolina

National Jewish Health

Overlake Hospital Bellevue WA

Pulmonary and Allergy Associates of New Jersey

Pulmonary Associates of Arizona

William Jennings Bryan Dorn VA Medical Center

Virginia Commonwealth University

Jamaica Hospital Medical Center

North Florida/South Georgia Veterans Health System

Steward St. Elizabeth's Medical Center of Boston, Inc.

University of California, Davis

Yale University

The Cleveland Clinic

Allegro Diagnostics, Corp.

Phenylalanine

All subjects are given 1 microgram \[D10\]phe before and after consuming Brussels sprouts once daily for 7 consecutive days.

Subjects are given \~150 g of Brussels sprouts once daily for 7 consecutive days.

Brussel Sprouts

Subjects are given 1 microgram of deuterated phenanthrene \[D10\]phe at baseline and after 7 days of Brussels sprout consumption. Urine is collected for 6 hours after each dose.

Deuterated Phenanthrene

Naomi Fujioka, MD

To determine whether glucobrassicin-rich Brussels sprouts can favorably modify the metabolism of the polycyclic aromatic hydrocarbon deuterated phenanthrene (\[D10\]phe) in current and former smokers

Subjects will be given 1 microgram of \[D10\]phe, and all urine will be collected for 6 h afterwards to quantify baseline levels of \[D10\]phenanthrene tetraol (\[D10\]pheT) and \[D10\]phenanthrols (\[D10\]HOP). Within 3 days of this baseline measurement, subjects will consume 200 micromoles of glucobrassicin in the form of raw Brussels sprouts (\~200-300 grams) at the study center once daily for 7 consecutive days. Urine will be collected for 24 h after vegetable consumption on days 3 ± 1 and 6 of the feeding intervention for 3,3'-diindolylmethane (DIM) quantification. On day 7 of the feeding intervention, a second dose of 1 microgram of \[D10\]phe will be administered at the study center after vegetable consumption, followed by another 6 h urine collection.

Glucobrassicin-Brussel Sprout Effect on D10 Phe Metabolism

Assessing the Effect of Glucobrassicin-Rich Brussels Sprouts on the Metabolism of Deuterated Phenanthrene: Developing Food-Based Chemoprevention of Tobacco-Related Lung Cancer

Urinary DIM will be quantified after Brussels sprout consumption on day 3 and day 6 of the feeding intervention for urinary DIM quantification

Compare level of urinary \[D10\]phenanthrene tetraol before and after 7 days of Brussels sprout consumption.

Compare level of urinary \[D10\]phenanthrene phenanthrols before and after 7 days of Brussels sprout consumption.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
18F-FSPG PET/CT in Diagnosing Early Lung Cancer in Patients With Lung Nodules	NCT03824535	Cigarette Smoke... Current Smoker Former Smoker Multiple Pulmon... Pulmonary Nodul...	Computed Tomogr... Fludeoxyglucose... Fluorine F 18 L... Positron Emissi...	45 Years -	Stanford University
Vanguard Study for Head and Neck Cancer or Non-Small Cell Lung Cancer (NSCLC) Patients	NCT00352391	Head and Neck C... Lung Cancer	Assessments	18 Years -	M.D. Anderson Cancer Center
Acetylsalicylic Acid Compared to Placebo in Treating High-Risk Patients With Subsolid Lung Nodules	NCT02169271	Current Smoker Former Smoker Multiple Pulmon... Tobacco Use Dis...	Aspirin Laboratory Biom... Placebo	50 Years -	National Cancer Institute (NCI)
Airway Epithelium Gene Expression: AEGIS IDE	NCT00746759	Lung Cancer	Biomarker (not ...	21 Years -	Allegro Diagnostics, Corp.
Glucobrassicin-Brussel Sprout Effect on D10 Phe Metabolism	NCT02999399	Smoking	Brussel Sprouts Deuterated Phen...	18 Years - 99 Years	Masonic Cancer Center, University of Minnesota

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