Actively Recruiting
Assessment of Radiation-Induced Vascular Complications in Patients With Head and Neck Cancers Using F-18 NaF and F-18 FDG PET/CT Imaging
Led by Emory University · Updated on 2025-10-22
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether an investigational PET/CT scan using sodium fluoride F-18 (F-18 NaF) is as effective or more effective than the standard PET/CT scan using fludeoxyglucose F-18 (F-18 FDG) for assessing how radiation therapy affects blood vessels in the neck of patients with head and neck cancers. The study focuses on patients receiving radiation targeting tumors and nearby glands, as radiation can impact the blood vessels supplying the brain. Participants are assigned to one of two groups. One group receives intensity-modulated radiation therapy (IMRT) and the other receives intensity-modulated proton therapy (IMPT), both considered standard treatments. Each participant undergoes PET/CT scans using F-18 NaF within 28 days before starting radiation and again 12 weeks after completing radiation. These scans are compared to standard F-18 FDG PET/CT scans done at the same times. During the study, patients receive intravenous F-18 NaF and undergo PET/CT imaging before and after their radiation treatment. Researchers assess radiation-induced vascular complications and inflammation up to six months after therapy. They also measure brain glucose uptake to explore effects on brain function. After completing imaging and treatment, patients are followed up within one to five business days to monitor outcomes and safety.
CONDITIONS
Brief Title
Comparing an Investigational Scan (F-18 NaF PET/CT) to Standard of Care Imaging (F-18 FDG PET/CT) for Evaluating Vascular Complications in Patients Receiving Radiation Therapy for Head and Neck Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females 18 years of age and older
- Diagnosis of clinical stage III-IVb squamous cell carcinoma of the oropharynx (HPV-negative), larynx, or hypopharynx, or clinical stage I-III HPV-associated squamous cell carcinoma of the oropharynx
- Planned treatment with concurrent chemoradiotherapy per institutional standard of care
- Consent to participate on an IRB-approved protocol-specific consent form
- Women of childbearing potential must have a negative pregnancy test at baseline and during study visits and agree to use effective contraception throughout the study
- Women who are postmenopausal for at least one year, sterile, or hysterectomized are eligible
- Women who have undergone tubal ligation must undergo pregnancy testing during each study visit
You will not qualify if you...
- Adults unable to provide consent
- Pregnant women
- Prisoners
- Patients who had chemotherapy or radiotherapy within 4 weeks prior to study entry or have unresolved toxicities greater than grade 1 from earlier treatments
- Patients receiving other investigational agents or devices within 21 days before F-18 NaF administration
- Patients planned for immunotherapy during or between radiotherapy and post-radiotherapy PET/CT imaging
- History of allergic reactions to compounds similar to F-18 NaF or other study agents
- Uncontrolled illnesses including active infection, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting compliance
- Significant cardiovascular disease within 3 months before study entry, including recent myocardial infarction, arterial or cerebrovascular thromboembolism, angina requiring therapy, symptomatic peripheral vascular disease, severe congestive heart failure, or uncontrolled hypertension despite treatment
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 6 months
Participants receive F-18 NaF intravenously and undergo PET/CT scans within 28 days of each standard of care F-18 FDG PET/CT scan, once before starting radiation therapy and once 12 weeks after completing radiation therapy.
2 visits (in-person), one before radiation therapy and one 12 weeks after completion
Duration - 1 week
Participants are followed up within one to five business days after completion of the study intervention to assess outcomes.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Actively Recruiting
Research Team
A
Amol M. Takalkar, MD, MS, MBA, FACNM
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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