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PMRR-NO: Pulmonary Metabolic Radiation Response Versus Exhaled Nitric Oxide | Clinical Trials | Clareo Health

COMPLETEDPhase 2NCT00867477

PMRR-NO: Pulmonary Metabolic Radiation Response Versus Exhaled Nitric Oxide

The goal of this clinical research study is to use a new breathing test that measures the amount of nitric oxide (NO) you exhale. Researchers want to compare your "NO" levels to the amount of inflamma...

Lead sponsor: M.D. Anderson Cancer Center•1 U.S. locations•View source on ClinicalTrials.gov

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Lead Sponsor

M.D. Anderson Cancer Center

Lung Cancer Cohort: NO Breathing Test: If you agree to take part in this study, you will have a breathing test performed before starting radiation therapy, weekly during radiation therapy and, about 6 weeks after the end of radiation therapy on the same day of your restaging PET scan. The breathing test measures how much NO you exhale while breathing. To complete this test, you will exhale into a device called an "NO breath analyzer" for 10 seconds. You will repeat this test 3 times. The results of this test will give researchers information about possible inflammation in your lungs. The results of this test will be compared to the results of your PET scan. For the first exhaled NO testing session, and any session in which you produce a high enough NO level, you will have the NO breath test repeated up to 4 times. The staff will ask you to exhale at different speeds during these repeated sessions, in order to learn where in your lungs the NO is coming from. Respiratory Symptoms Questionnaire: At each visit when you have NO breathing tests, you will be asked to complete a questionnaire about your breathing and any symptoms you may be having. A research assistant will be able to help you with completing the questionnaire. It should take about 10 minutes to complete the questionnaire. PET scans: After completing your radiation therapy, you will receive a PET scan as part of this study. The PET scan will be scheduled for you between 40 and 50 days after the end of the radiation therapy. A study staff member will call you with the PET scan date. Ten (10) participants will receive a second PET scan within 2-7 days after the first PET scan in order to check reproducibility. For up to 6 hours before the PET scan, you must not eat or drink anything except water. A small tube will be placed in your arm, and you will receive an injection of a very small amount of a mildly radioactive sugar material into your bloodstream. The radioactive nature of this injected material allows the scanner to "see" it in certain places in your body. After the injection, you will need to rest quietly until it is time for the scan. The amount of rest time may vary, but be prepared to wait for between 45 and 90 minutes. During the scan, you will lie flat on your back on a table. The scan itself may last up to 1 hour. Length of Study: You will remain on study for up to 7 months. After you have completed the breathing tests, blood draws, questionnaires, and PET scans, your participation on this study will be over. This is an investigational study. The device (called an NO breath analyzer) used in this study is FDA approved and commercially available for measuring exhaled NO levels in patients with asthma. The use of the PET scan and blood test to check lung inflammation is also investigational. Up to 150 patients (up to 47 with lung cancer) will take part in this study. All will be enrolled at MD Anderson. Esophageal Cancer Cohort: NO Breathing Test: If you agree to take part in this study, you will have a breathing test performed before starting radiation therapy, about 5 weeks later after radiation therapy is complete (at the end of radiation therapy), and the same day of your restaging PET scan. The breathing test measures how much NO you exhale while breathing. To complete this test, you will exhale into a device called an "NO breath analyzer" for 10 seconds. You will repeat this test 3 times. The results of this test will give researchers information about possible inflammation in your lungs. The results of this test will be compared to the results of your PET scan. For the first exhaled NO testing session, and any session in which you produce a high enough NO level, you will have the NO breath test repeated up to 4 times. The staff will ask you to exhale at different speeds during these repeated sessions, in order to learn where in your lungs the NO is coming from. Respiratory Symptoms Questionnaire: At each visit when you have 3 NO breathing tests, you will be asked to complete a questionnaire about your breathing and any symptoms you may be having. A research assistant will be able to help you with completing the questionnaire. It should take about 10 minutes to complete the questionnaire. Length of Study: After you have completed the breathing tests and the questionnaires, your participation on this study will be over. This is an investigational study. The device (called an NO breath analyzer) used in this study is FDA approved and commercially available for measuring exhaled NO levels in patients with asthma. Its use in patients with esophageal cancer is investigational. The optional SPECT scans using 99m Tc-HMPAO are an FDA approved standard imaging method for infection and/or inflammation. Up to 150 patients (up to 93 with esophageal cancer) will take part in this study. All will be enrolled at MD Anderson.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: August 28, 2014Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE2

Enrollment163

Start dateMar 2009

Last updatedAug 28, 2014

Condition

Gastrointestinal Disease Esophageal Cancer Lung Cancer

Locations shown

UT MD Anderson Cancer Center

Houston, Texas

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 28, 2014Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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