This early phase I trial compares sodium fluoride F-18 (F-18 NaF) positron emission tomography (PET)/computed tomography (CT) to the standard of care imaging scan (and fludeoxyglucose F-18 \[F-18 FDG\] PET/CT) for assessing the effects radiation therapy has on the blood vessels in the neck in patients with head and neck cancers. For people with cancers in the head and neck, doctors often use radiation to target both the tumor and nearby glands. Radiation therapy to this region can affect the blood vessels in the neck that supply blood to the brain. F-18 NaF and F-18 FDG are contrast agents that can be used together with PET/CT imaging to visualize areas inside the body. A PET scan is a procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. A CT scan is a procedure that uses a computer linked to an x-ray machine to make a series of detailed pictures of areas inside the body. The pictures are taken from different angles and are used to create 3-dimensional views of tissues and organs. Combining a PET scan with a CT scan can help make the image easier to interpret. PET/CT scans are hybrid scanners that combine both modalities into a single scan during the same examination. Imaging with F-18 NaF PET/CT may be as effective or more effective than the standard F-18 FDG PET/CT for assessing the effects radiation therapy has on blood vessels in the neck in patients with head and neck cancers.
PRIMARY OBJECTIVES: I. To determine the role of FDG- and NaF-PET in assessing radiation-induced vascular complications by comparing baseline and follow-up scans in patients with head and neck cancer. II. To assess the presence and extent of radiation-induced vascular inflammation following proton versus (vs) photon radiation therapy (RT) in patients with head and neck cancer. III. To determine the correlation between inflammation and actual radiation dose received to the vasculature to assess the effects of dose response. SECONDARY OBJECTIVE: I. To determine the effect of radiation-induced vascular inflammation (possibly atherosclerosis) on global brain function as measured by FDG-PET. OUTLINE: Patients are assigned to 1 of 2 arms. ARM I: Patients receive F-18 NaF intravenously (IV) and undergo PET/CT within 28 days of each standard of care (SOC) F-18 FDG PET/CT on study, once prior to initiation of SOC intensity-modulated radiation therapy (IMRT) and once 12 weeks after completion of SOC IMRT. ARM II: Patients receive F-18 NaF IV and undergo PET/CT within 28 days of each SOC F-18 FDG PET/CT on study, once prior to initiation of SOC intensity-modulated proton therapy (IMPT) and once 12 weeks after completion of SOC IMPT. After completion of study intervention, patients are followed up within one to five business days.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
20
Undergo PET/CT
Given F-18 FDG
Undergo IMPT
Undergo IMRT
Undergo PET/CT
Given IV
Emory University Hospital Midtown
Atlanta, Georgia, United States
RECRUITINGRadiation-induced vascular complications
Will compare the presence and extent of radiation therapy (RT)-induced vascular complications between the two treatment modalities. The average standardized uptake volume (SUV) max and mean of fludeoxyglucose F-18 (FDG)- and sodium fluoride F-18 (NaF)-positron emission tomography (PET)/computed tomography (CT) scans pre- and post RT will be computed. Will assess the change in average SUVmax and SUVmean of FDG- and NaF-PET/CT scans pre- and post-RT. Will also assess the difference in average SUV mean between proton and photon RT. Will assess the difference in change in SUV mean between intensity-modulated radiation therapy (IMRT) and intensity-modulated photon therapy (IMPT) using a two-sample independent t-test or the Wilcoxon rank sum test for each SUVmean/max. A multivariable linear regression model with a backward elimination approach will be used to test the effect of clinicopathological variables on the change in SUVmax.
Time frame: Prior to and after undergoing radiation therapy, up to 6 months
Radiation-induced vascular inflammation following IMRT or IMPT
Will evaluate the presence and extent of radiation-induced vascular inflammation following IMRT versus IMPT. Will determine the correlation between the actual radiation dose and radiation-induced vascular inflammation, measured by the average SUVmax/mean, and will be done using Pearson's correlation or Spearman's correlation analysis, as appropriate.
Time frame: Baseline up to 6 months
Percentage volumetric dose
The percentage volumetric dose will be recorded to determine the correlation between the actual radiation dose and the radiation-induced vascular inflammation, measured by the average SUVmax/mean, and will be done using Pearson's correlation or Spearman's correlation analysis, as appropriate.
Time frame: Baseline up to 6 months
Total brain FDG uptake
Will assess the association of total brain FDG uptake between the two scanning methods (FDG and NaF PET/CT). The total brain FDG uptake pre- and post-RT will be measured. Will assess the association between the average SUVmax/mean difference of FDG- and NaF-PET/CT scans and the total brain FDG uptake. Will be performed using Pearson's correlation or Spearman's correlation analysis, as appropriate.
Time frame: Baseline up to 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.