Trials / Recruiting

RecruitingNCT06914999

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

Assessment of Radiation-Induced Vascular Complications in Patients With Head and Neck Cancers With PET/CT Imaging

Status: Recruiting
Phase: EARLY_Phase 1
Study type: Interventional
Enrollment: 20 (estimated)

Sponsor: Emory University · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography	Undergo PET/CT
OTHER	Fludeoxyglucose F-18	Given F-18 FDG
PROCEDURE	Intensity-Modulated Proton Therapy	Undergo IMPT
RADIATION	Intensity-Modulated Radiation Therapy	Undergo IMRT
PROCEDURE	Positron Emission Tomography	Undergo PET/CT
DRUG	Sodium Fluoride F-18	Given IV

Timeline

Start date: 2024-12-03
Primary completion: 2026-08-31
Completion: 2027-08-31
First posted: 2025-04-07
Last updated: 2025-10-22

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT06914999. Inclusion in this directory is not an endorsement.