Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
NCT06914999

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

Led by Emory University · Updated on 2025-10-22

20

Participants Needed

1

Research Sites

143 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

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.

CONDITIONS

Official 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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years 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
  • Receiving curative-intent, organ preservation (non-surgical) treatment with concurrent chemoradiotherapy per institutional standard of care
  • Radiation therapy delivered per institutional standard of care
  • Ability to provide informed consent using an IRB-approved consent form
  • Women of childbearing potential must have a negative pregnancy test at baseline and follow-up visits
  • Women of childbearing potential must agree to use at least one approved contraception method 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 at each study visit
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent
  • Pregnant women
  • Prisoners
  • Chemotherapy or radiotherapy within 4 weeks prior to study entry or unresolved adverse events greater than grade 1 from treatments given more than 4 weeks earlier
  • Receiving other investigational agents or devices within 21 days before F-18 NaF administration
  • Planned to receive immunotherapy during radiotherapy or between radiotherapy and post-radiation PET/CT imaging
  • History of allergic reactions to compounds similar to F-18 NaF or other study agents
  • Uncontrolled illnesses such as active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social conditions limiting compliance
  • Significant cardiovascular disease within 3 months prior to study entry including myocardial infarction, arterial or cerebrovascular thromboembolism, angina requiring therapy, symptomatic peripheral vascular disease, New York Heart Association class 3 or 4 heart failure, or uncontrolled grade ≥ 3 hypertension despite treatment

AI-Screening

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Trial Site Locations

Total: 1 location

1

Emory University Hospital Midtown

Atlanta, Georgia, United States, 30308

Actively Recruiting

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Research Team

A

Amol M. Takalkar, MD, MS, MBA, FACNM

CONTACT

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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