NCT00867477

Brief Summary

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 positron emission tomography (PET) scan reading, and with respiratory symptoms questionnaire.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
163

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2009

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 23, 2009

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

August 28, 2014

Status Verified

August 1, 2014

Enrollment Period

5.4 years

First QC Date

March 20, 2009

Last Update Submit

August 27, 2014

Conditions

Gastrointestinal DiseaseEsophageal CancerLung Cancer

Keywords

Cancer of esophagusGastrointestineesophagus cancerPositron emission tomographyPET scanNitric oxideNONO Breathing TestRespiratory symptoms questionnaire

Outcome Measures

Primary Outcomes (1)

  • Comparison Patient's PMRR + Mean Exhaled NO Measurement

    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.

    Before starting radiation therapy (RT), after completing RT, and approximately 5 weeks later at completion of RT, and same day of restaging PET scan.

Study Arms (2)

Cohort 1: Esophagus Cancer

EXPERIMENTAL

Breathing Test + Respiratory Symptoms Questionnaire

Procedure: Breathing TestBehavioral: Respiratory Symptoms Questionnaire

Cohort 2: Lung Cancer

EXPERIMENTAL

Breathing Test + Respiratory Symptoms Questionnaire

Procedure: Breathing TestBehavioral: Respiratory Symptoms QuestionnaireProcedure: Pet Scan

Interventions

Breathing TestPROCEDURE

Exhale into NO breath analyzer for 10 seconds, repeated 3 times (before radiation therapy starts, after completing radiation therapy, and after scheduled PET scan).

Cohort 1: Esophagus CancerCohort 2: Lung Cancer
Respiratory Symptoms QuestionnaireBEHAVIORAL

3 page questionnaire about breathing and any symptoms experienced, at each of 2 NO breathing tests.

Also known as: survey
Cohort 1: Esophagus CancerCohort 2: Lung Cancer
Pet ScanPROCEDURE

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.

Cohort 2: Lung Cancer

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with pathologic diagnosis of esophagus cancer.
  • For the cohort 2, patients with the pathological diagnosis of lung cancer.
  • For the cohort 3, patients with any pathological diagnosis of a thoracic malignancy.
  • Patients must sign informed consent.
  • Patients who will receive concurrent chemotherapy and radiation therapy will be undergoing PET-scan for restaging between 25 and 75 days after radio therapy.
  • For Lung Cohort, patients who will receive concurrent chemotherapy and radiation therapy or greater or equal to 3 weeks of radiation therapy alone.
  • 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.

You may not qualify if:

  • Significant pleural effusion as evaluated by the attending Radiation Oncologist is excluded.
  • Patients who received thoracic radiotherapy prior to the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Gastrointestinal DiseasesEsophageal NeoplasmsLung Neoplasms

Interventions

Surveys and QuestionnairesMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Digestive System DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEsophageal DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthSpectrum AnalysisChemistry Techniques, Analytical

Study Officials

  • Thomas Guerrero, MD, PhD

    UT MD Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2009

First Posted

March 23, 2009

Study Start

March 1, 2009

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

August 28, 2014

Record last verified: 2014-08

Locations

US(1)