Non-Small Cell Lung Cancer Clinical Trial
Official title:
Using Functional Image and Circulating Molecular Markers to Predict Tumor Response and Lung Toxicity in Treatment of Lung Cancer
Verified date | October 2019 |
Source | University of Michigan Rogel Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Successful treatment of non-small cell lung cancer with radiation therapy requires that the
physicians determine exactly where the tumor is in your body and protect your normal tissue.
This study is designed to apply functional imaging, Fluorodeoxyglucose-Positron Emission
Tomography (FDG-PET) and Ventilation/Perfusion Single Photon Emission Computerized Tomography
(V/Q SPECT), before treatment and then again during treatment to see if it helps predict how
well the treatment works for your cancer and how well your lung functions during treatment. A
Computerized Tomography (CT) will also be performed along with both of these procedures to
help the researchers see clearly where your cancer or your healthy lung is located.
The researchers are also doing blood tests in this study to look for markers in your blood
and to see if it helps them in determining your risk of developing side effects from
radiation to the lungs. The researchers hope that this study will help them in the future to
design radiation treatment plans that provide the best treatment for each individual patient.
Status | Completed |
Enrollment | 115 |
Est. completion date | March 2015 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologically confirmed Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC) clinically diagnosed providing that FDG-PET is positive. - Stage I to III lung cancer requiring definitive irradiation with or without chemotherapy. - Patients with a locoregional tumor recurrence following surgery will be eligible provided they meet other eligibility criteria. - Patients must be 18 years of age or older. - Female patients with reproductive capability must be willing to use effective contraception - Patients must sign an informed consent form for study. Exclusion Criteria: - Malignant pleural or pericardial effusion. - Pregnancy - Lactation - Patients with diabetes mellitus, with uncontrolled fasting blood glucose level (above 200 mg/dl) - Inability to lie flat for the duration of PET/CT and V/Q SPECT (approximately 45 minutes for each study) - Prisoners are excluded from this study. |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan Rogel Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary aim of this study is to investigate predictive models for long-term tumor control and late treatment lung toxicity by using FDG-PET-CT, V/Q SPECT-CT and blood tests during the course of radiation therapy. | During treatment with radiation at 40-50 Gy and up to 5 yrs after radiation completed |
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