Fludeoxyglucose F-18-PET in Planning Lung Cancer Radiation Therapy

Study Overview
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Brief Summary
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This trial studies how well fludeoxyglucose F-18 - positron emission tomography (PET) works in planning radiation therapy in participants with early non-small cell lung cancer, early stage lung cancer, or cancer that has spread to lungs from other parts of the body. Using PET in addition to the standard computed tomography to plan radiation therapy for cancer may help doctors to maximize the dose to the cancer and minimize the dose to normal tissues.

Detailed Description
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PRIMARY OBJECTIVE: To determine the maximum inter-fraction variability of fludeoxyglucose F-18 (18-F FDG)-PET activity of thoracic tumor treatment volumes through a 5-fraction stereotactic body radiation therapy (SBRT) course as it relates to the planning feasibility of emission-guided radiation therapy, or biologically-guided radiation therapy (BgRT). SECONDARY OBJECTIVES: I. To compare similar inter-fraction variability of FDG-PET activity for non-thoracic SBRT target volumes for the purpose of determining the feasibility of BgRT. II. To compare dosimetric endpoints for primary tumor coverage and dose to organs at risk between conventional SBRT planning and simulated BgRT, or emission-guided radiation therapy planning for thoracic and non-thoracic targets. III. To compare dosimetry for primary tumor coverage and dose to organs at risk between adaptive cone beam computed tomography (CT) planning, and simulated adaptive emission-guided radiation therapy (BgRT) planning for thoracic and non-thoracic targets. IV. To compare variability of 18-F FDG-PET in patients undergoing immunotherapy simultaneously during SBRT, or within 4 weeks of SBRT treatment with patients undergoing SBRT but not receiving immunotherapy. OUTLINE: Participants receive fludeoxyglucose F-18 intravenously (IV) and after 60 minutes undergo PET within 4 weeks of the first planned SBRT fraction, prior to the second planned fraction, and prior to the fifth planned fraction.

Official Title
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A Pilot Study of FDG-PET Variability to Establish Biology-Guided Treatment Planning Feasibility for Stereotactic Body Radiation Therapy

Conditions
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Stage I Lung Cancer, Stage I Non-Small Cell Lung Cancer AJCC v7, Stage IA Non-Small Cell Lung Carcinoma AJCC v7, Stage IB Non-Small Cell Lung Carcinoma AJCC v7, Stage II Lung Cancer, Stage II Non-Small Cell Lung Cancer AJCC v7, Stage IIA Non-Small Cell Lung Carcinoma AJCC v7, Stage IIB Non-Small Cell Lung Carcinoma AJCC v7

Intervention / Treatment
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* Drug: Fludeoxyglucose F-18
* Procedure: Positron Emission Tomography (PET)
* Radiation: Stereotactic Body Radiation Therapy (SBRT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are offered radiotherapy using a 5-fraction stereotactic body radiation therapy course, at the recommendation of the treating radiation oncologist Patients with early non-small cell lung carcinoma, or clinically-diagnosed early stage lung cancer, or pulmonary metastases Patients with a limited (1-5) number of metastatic foci outside of the thorax who are candidates for consolidative treatment with SBRT Patient with either a single focus or multiple foci (multi-isocentric planning) of disease in the thorax amenable to SBRT with at least one focus with at least 1.5 cm or larger in its largest diameter Patients who are planned to receive either chemotherapy, targeted therapy, immunotherapy, or no additional cancer-directed drug therapy Exclusion Criteria: Prior radiation therapy which would provide significant dose overlap with the planned target volume(s) delivered within 30 days of enrollment or registration Major invasive surgical procedure occurring between the first treatment-eligible PET/CT examination and end of radiotherapy that would affect the treatment target region Patients with minimal FDG-avidity localized to the planned treatment target (e.g. maximum standardized uptake value [SUV] < 4.0) Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (FDG-PET, SBRT)<br>Participants receive fludeoxyglucose F-18 IV and after 60 minutes undergo positron emission tomography (PET) within 4 weeks of the first planned stereotactic body radiation therapy (SBRT) fraction, prior to the second planned fraction, and prior to the fifth planned fraction. | Drug: Fludeoxyglucose F-18<br>* Given IV<br>* Other names: Fluorine-18 2-Fluoro-2-deoxy-D-Glucose;Procedure: Positron Emission Tomography (PET)<br>* Undergo FDG-PET<br>* Other names: Proton magnetic resonance spectroscopic imaging;Radiation: Stereotactic Body Radiation Therapy (SBRT)<br>* Undergo SBRT<br>* Other names: Stereotactic ablative body radiation therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in metabolic tumor volumes measuring inter-fraction variability of fludeoxyglucose F-18-PET (FDG) - positron emission tomography (PET) activity of thoracic stereotactic body radiation therapy (SBRT) target volumes | Metabolic tumor volumes across the treatment continuum, i.e. pre-treatment, before second fraction and before the last fraction of treatment, will be compared. The observed % change from baseline will be calculated at all time points for all 15 patients and for every tumor treated with SBRT. | Up to 6 weeks from study start | 
| Change in total lesion glycolysis values measuring inter-fraction variability of fludeoxyglucose F-18-PET (FDG) - positron emission tomography (PET) activity of thoracic stereotactic body radiation therapy (SBRT) target volumes | Total lesion glycolysis values across the treatment continuum, i.e. pre-treatment, before second fraction and before the last fraction of treatment, will be compared. The observed % change from baseline will be calculated at all time points for all 15 patients and for every tumor treated with SBRT. | Up to 6 weeks from study start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in metabolic tumor volumes measuring inter-fraction variability of fludeoxyglucose F-18-PET (FDG) - positron emission tomography (PET) activity of non-thoracic stereotactic body radiation therapy (SBRT) target volumes | Metabolic tumor volumes across the treatment continuum, i.e. pre-treatment, before second fraction and before the last fraction of treatment, will be compared. The observed % change from baseline will be calculated at all time points for all 15 patients. | Up to 6 weeks from study start | 
| Change in total lesion glycolysis values measuring inter-fraction variability of fludeoxyglucose F-18-PET (FDG) - positron emission tomography (PET) activity of non-thoracic stereotactic body radiation therapy (SBRT) target volumes | Total lesion glycolysis values across the treatment continuum, i.e. pre-treatment, before second fraction and before the last fraction of treatment, will be compared. The observed % change from baseline will be calculated at all time points for all 15 patients. | Up to 6 weeks from study start |