Fludeoxyglucose F-18-PET in Planning Lung Cancer Radiation Therapy
A Pilot Study of FDG-PET Variability to Establish Biology-Guided Treatment Planning Feasibility for Stereotactic Body Radiation Therapy
4 other identifiers
interventional
19
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Apr 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2018
CompletedFirst Posted
Study publicly available on registry
April 11, 2018
CompletedStudy Start
First participant enrolled
April 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 19, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 19, 2019
CompletedOctober 18, 2023
October 1, 2023
11 months
March 20, 2018
October 17, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
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
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
Up to 6 weeks from study start
Study Arms (1)
Diagnostic (FDG-PET, SBRT)
EXPERIMENTALParticipants 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.
Interventions
Given IV
Undergo FDG-PET
Undergo SBRT
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
- RefleXion Medicalcollaborator
- National Cancer Institute (NCI)collaborator
- National Institutes of Health (NIH)collaborator
Study Sites (1)
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kristin Higgins, MD
Emory University Hospital/Winship Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 20, 2018
First Posted
April 11, 2018
Study Start
April 13, 2018
Primary Completion
March 19, 2019
Study Completion
March 19, 2019
Last Updated
October 18, 2023
Record last verified: 2023-10