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

This study is currently recruiting participants.
Verified April 2013 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00867477
First received: March 20, 2009
Last updated: April 23, 2013
Last verified: April 2013
History of Changes
  Purpose

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 inflammation in your lungs, as measured using a PET scan reading, and with respiratory symptoms questionnaire.


Condition Intervention Phase
Gastrointestinal Disease
Esophageal Cancer
Lung Cancer
 Procedure: Breathing Test
Behavioral: Respiratory Symptoms Questionnaire
Procedure: Pet Scan
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Biomarker Study Comparing the Pulmonary Metabolic Radiation Response Versus Exhaled Nitric Oxide in Patients Who Receive Thoracic Radiotherapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Comparison Patient's PMRR + Mean Exhaled NO Measurement [ Time Frame: Before starting radiation therapy (RT), after completing RT, and approximately 5 weeks later at completion of RT, and same day of restaging PET scan. ] [ Designated as safety issue: No ]
    Association between exhaled nitric oxide (NO) and PMRR (pulmonary metabolic radiation response). FDG-PET imaging (to determine PMRR) and exhaled NO assessed three times on same day of PET imaging.


Estimated Enrollment: 150
Study Start Date: March 2009
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1: Esophagus Cancer
Breathing Test + Respiratory Symptoms Questionnaire
 Procedure: 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).
Behavioral: Respiratory Symptoms Questionnaire
3 page questionnaire about breathing and any symptoms experienced, at each of 2 NO breathing tests.
Other Name: survey
Experimental: Cohort 2: Lung Cancer
Breathing Test + Respiratory Symptoms Questionnaire
 Procedure: 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).
Behavioral: Respiratory Symptoms Questionnaire
3 page questionnaire about breathing and any symptoms experienced, at each of 2 NO breathing tests.
Other Name: survey
Procedure: 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.

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  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with pathologic diagnosis of esophagus cancer.
  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:

  1. Significant pleural effusion as evaluated by the attending Radiation Oncologist is excluded.
  2. Patients who received thoracic radiotherapy prior to the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00867477

Contacts
Contact: Thomas Guerrero, MD, PhD 713-563-2300

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Thomas Guerrero, MD, PhD            
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Thomas Guerrero, MD, PhD UT MD Anderson Cancer Center
  More Information

Additional Information:
UT MD Anderson Cancer Center website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00867477     History of Changes
Other Study ID Numbers: 2008-0632
Study First Received: March 20, 2009
Last Updated: April 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Cancer of esophagus
Gastrointestine
esophagus cancer
Positron emission tomography
PET scan
 Nitric oxide
NO
NO Breathing Test
Respiratory symptoms questionnaire

Additional relevant MeSH terms:
Esophageal Diseases
Esophageal Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Lung Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Nitric Oxide
 Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 18, 2013