RecruitingEarly Phase 1NCT06914999

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


Sponsor

Emory University

Enrollment

20 participants

Start Date

Dec 3, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a specialized bone scan (F-18 NaF PET/CT — a type of nuclear imaging that highlights bone activity) to standard imaging for detecting and monitoring cancer in the bones of people with head and neck cancer undergoing radiation and chemotherapy. **You may be eligible if...** - You are 18 or older - You have squamous cell carcinoma of the throat (HPV-negative), voice box, or lower throat at stage III–IVb — OR — HPV-positive throat cancer at stage I–III - You are receiving standard chemoradiotherapy (radiation combined with chemotherapy) as your primary treatment - You are able to provide consent **You may NOT be eligible if...** - You have had chemotherapy or radiation within the past 4 weeks - You are currently enrolled in another investigational treatment trial - You are pregnant - You are unable to consent (including prisoners) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREComputed Tomography

Undergo PET/CT

OTHERFludeoxyglucose F-18

Given F-18 FDG

PROCEDUREIntensity-Modulated Proton Therapy

Undergo IMPT

RADIATIONIntensity-Modulated Radiation Therapy

Undergo IMRT

PROCEDUREPositron Emission Tomography

Undergo PET/CT

DRUGSodium Fluoride F-18

Given IV


Locations(1)

Emory University Hospital Midtown

Atlanta, Georgia, United States

View Full Details on ClinicalTrials.gov

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NCT06914999


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