PMRR-NO: Pulmonary Metabolic Radiation Response Versus Exhaled Nitric Oxide
NCT ID: NCT00867477
Last Updated: 2014-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
163 participants
INTERVENTIONAL
2009-03-31
2014-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Phase II Evaluation of Exhaled Nitric Oxide (NO)
NCT01392144
Using Imaging and Molecular Markers to Predict Tumor Response and Lung Toxicity in Lung Cancer
NCT00603057
A Study on Predictive Models and Clinical Outcome of Radiation Pneumonitis
NCT05448703
Breath Combined With CT for Diagnoses of Pulmonary Nodules
NCT04948047
Using Infrared Spectroscopy to Analyze Volatile Organic Compounds (VOCs) in the Breath of Patients With Lung Cancer
NCT06288646
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
SCREENING
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort 1: Esophagus Cancer
Breathing Test + Respiratory Symptoms Questionnaire
Breathing Test
Exhale into NO breath analyzer for 10 seconds, repeated 3 times (before radiation therapy starts, after completing radiation therapy, and after scheduled PET scan).
Respiratory Symptoms Questionnaire
3 page questionnaire about breathing and any symptoms experienced, at each of 2 NO breathing tests.
Cohort 2: Lung Cancer
Breathing Test + Respiratory Symptoms Questionnaire
Breathing Test
Exhale into NO breath analyzer for 10 seconds, repeated 3 times (before radiation therapy starts, after completing radiation therapy, and after scheduled PET scan).
Respiratory Symptoms Questionnaire
3 page questionnaire about breathing and any symptoms experienced, at each of 2 NO breathing tests.
Pet Scan
Between 40 and 50 days after the end of the radiation therapy. Ten (10) participants will receive a second PET scan within 2-7 days after the first PET scan in order to check reproducibility.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Breathing Test
Exhale into NO breath analyzer for 10 seconds, repeated 3 times (before radiation therapy starts, after completing radiation therapy, and after scheduled PET scan).
Respiratory Symptoms Questionnaire
3 page questionnaire about breathing and any symptoms experienced, at each of 2 NO breathing tests.
Pet Scan
Between 40 and 50 days after the end of the radiation therapy. Ten (10) participants will receive a second PET scan within 2-7 days after the first PET scan in order to check reproducibility.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. For the cohort 2, patients with the pathological diagnosis of lung cancer.
3. For the cohort 3, patients with any pathological diagnosis of a thoracic malignancy.
4. Patients must sign informed consent.
5. Patients who will receive concurrent chemotherapy and radiation therapy will be undergoing PET-scan for restaging between 25 and 75 days after radio therapy.
6. For Lung Cohort, patients who will receive concurrent chemotherapy and radiation therapy or greater or equal to 3 weeks of radiation therapy alone.
7. For the Lung Cohort, participation in a PET-scan for restaging between 40-50 days after radiotherapy is required. 10 patients will receive a second PET-scan within 2-7 days as a test for reproducibility.
Exclusion Criteria
2. Patients who received thoracic radiotherapy prior to the study.
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
M.D. Anderson Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Thomas Guerrero, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UT MD Anderson Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UT MD Anderson Cancer Center
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
UT MD Anderson Cancer Center website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2008-0632
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.