Using Functional Image and Circulating Molecular Markers to Predict Tumor Control and Thoracic Toxicity in Treatment of Lung Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Indiana University
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Investigate predictive models for long-term tumor control and late treatment lung toxicity by using FDG-PET-CT, V/Q SPECT-CT and blood test during the course of radiation therapy.
Study Overview
Brief Summary
This study is designed to apply various scans such as functional imaging, Fluorodeoxyglucose_Positron Emission Tomography (FDG-PET), 62Cu-ETS (Copper) PET, Ventilation/Perfusion Single Photon Emission Computerized Tomography (V/Q SPECT), cardiac magnetic resonance imaging (MRI), Tc-99m HMPAO SPECT/CT, and pulmonary function tests before, during and after treatment to see if it predicts how well the treatment works for your cancer and how well your lungs function 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 also perform blood tests in this study to look for markers in your blood to see if it helps them determine your risk of developing side effects from radiation to the lungs. They will also measure your health-related quality of life before, during and after treatment. 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.
Detailed Description
Primary aims:
- To determine if tumor metabolic activity plus volume measured by 18F-FDG PET/CT and tissue/tumor perfusion measured by 62Cu-ETS-PET before and during treatment predicts CT tumor response 3 months after completion of treatment and 1 and 2 year local-regional progression-free survival.
- To determine if functional imaging based lung dose-volume histograms (DVH) more accurately predict changes in diffusion capacity of lung for carbon monoxide (DLCO) compared to the DVH based on simulating CT. Degree of lung toxicity will also be documented by functional scans such as Tc-99m HMPAO imaging.
- To determine if baseline level, or changes in blood markers such as TGFß1 measured during the course of radiation, predict changes in DLCO.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Investigate predictive models for long-term tumor control and late treatment lung toxicity by using FDG-PET-CT, V/Q SPECT-CT and blood test during the course of radiation therapy.
Time Frame: Up to 5 years after radiation completion
Investigate predictive models for long-term tumor control and late treatment lung toxicity by using FDG-PET-CT, V/Q SPECT-CT and blood test during the course of radiation therapy. As secondary analysis, demographic and baseline clinical variables will be added to the model to determine if they add predictive value.
Secondary Outcomes
No secondary outcomes reported
Investigators
Tim Lautenschlaeger
Assistant Professor of Radiation Oncology
Indiana University