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Comparing F-18 NaF PET/CT to F-18 FDG PET/CT for Head and Neck Cancer

This study is comparing a new imaging scan, F-18 NaF PET/CT, to the standard scan, F-18 FDG PET/CT, to see how radiation therapy affects blood vessels in the neck of people with head and neck cancers. Radiation therapy can sometimes impact these blood vessels, which supply blood to the brain. Researchers want to understand if F-18 NaF PET/CT can better show these changes. You may be eligible if you are 18 or older and have certain types of head and neck squamous cell carcinoma, including HPV-associated oropharyngeal cancer. The study aims to see if the new scan can more accurately detect vascular complications and inflammation caused by radiation. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 20 participants. It compares two different imaging approaches in patients receiving either intensity-modulated radiation therapy (IMRT) or intensity-modulated proton therapy (IMPT).
What's involved
You would receive F-18 NaF intravenously and undergo PET/CT scans within 28 days of your standard F-18 FDG PET/CT scans, both before and about 12 weeks after your radiation therapy.
Compensation
Not stated in the trial record.
Follow-up
After completing the study interventions, participants will have a follow-up within one to five business days. Researchers will also measure vascular complications and inflammation for up to 6 months.

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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

Recruiting
EARLY_PHASE1Ages 18+InterventionalDiagnostic
Emory University
~20 participants
Updated 2025-10-22 on ClinicalTrials.gov
What's tested:Computed TomographyFludeoxyglucose F-18Intensity-Modulated Proton TherapyIntensity-Modulated Radiation TherapyPositron Emission TomographySodium Fluoride F-18

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Radiation-induced vascular complications
Measured over Prior to and after undergoing radiation therapy, up to 6 months
+2 more outcomes measured

Conditions

Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Head and Neck Squamous Cell Carcinoma
Hypopharyngeal Squamous Cell Carcinoma
Laryngeal Squamous Cell Carcinoma
Oropharyngeal Squamous Cell Carcinoma
Stage III Hypopharyngeal Carcinoma AJCC v8
Stage III Laryngeal Cancer AJCC v8
Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Stage IVA Hypopharyngeal Carcinoma AJCC v8
Stage IVA Laryngeal Cancer AJCC v8
Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Stage IVB Hypopharyngeal Carcinoma AJCC v8
Stage IVB Laryngeal Cancer AJCC v8
Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8

Explore related trials

Head and Neck Squamous Cell CarcinomaHypopharyngeal Squamous Cell CarcinomaLaryngeal Squamous Cell CarcinomaOropharyngeal Squamous Cell Carcinoma

Where it's being run

1 sites across 1 states
Georgia1

Study leadership

  • Amol M Takalkar, MD, MS, MBA, FACNM · PRINCIPAL_INVESTIGATOR · Emory University

Who to contact

Amol M. Takalkar, MD, MS, MBA, FACNM
[email protected]
404-712-4843
Email the study team

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Eligibility criteria

Inclusion

Males and females 18 years of age and older
Diagnosis of clinical stage III-IVb (American Joint Committee on Cancer \[AJCC\] 8th edition) squamous cell carcinoma of the oropharynx (human papillomavirus \[HPV\]-negative), larynx, or hypopharynx, or clinical stage I-III (AJCC 8th edition) HPV-associated squamous cell carcinoma of the oropharynx receiving curative-intent, organ preservation (non-surgical)
Treatment with concurrent chemoradiotherapy per institutional standard of care at the discretion of Medical Oncology. RT is delivered per institutional standard of care at the discretion of Radiation Oncology
Patients must give protocol-specific consent on an Institutional Review Board (IRB)-approved consent form prior to completion of protocol-specific testing/procedures
Women are eligible to participate in the study if they meet one of the following criteria:
Females of childbearing potential (FCBP) must have a negative pregnancy test at baseline and follow-up visit. Women of childbearing potential must undergo pregnancy testing during each study visit and agree to use at least one of the following methods of contraception throughout the study duration:
Oral contraceptives, transdermal contraceptives, injectable or implantable methods, intrauterine devices, and/or vaginal ring
Women who are postmenopausal (for at least one year), sterile, or hysterectomized;
Women who have undergone tubal ligation will be required to undergo pregnancy testing during each study visit

Exclusion

Adults who are unable to consent
Pregnant women
Prisoners
Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier (i.e., have residual toxicities \> grade 1)
Patients who are receiving any other investigational agents or an investigational device within 21 days before administration of the F-18 NaF for the pre-RT PET/CT imaging
Patients planned to receive any immunotherapy agent during their radiotherapy or in the interval between radiotherapy and post-RT PET/CT imaging
History of allergic reactions attributed to compounds of similar chemical or biological composition to F-18 NaF or other agents used in the study
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Significant cardiovascular disease (eg, myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism) within 3 months prior to study entry; angina requiring therapy; symptomatic peripheral vascular disease; New York Heart Association class 3 or 4 congestive heart failure; or uncontrolled grade \>= 3 hypertension (diastolic blood pressure \>= 100 mmHg or systolic blood pressure \>= 160 mmHg) despite antihypertensive therapy

What this trial measures

  • Radiation-induced vascular complicationsPrior to and after undergoing radiation therapy, up to 6 months

    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.

  • Radiation-induced vascular inflammation following IMRT or IMPTBaseline up to 6 months

    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.

  • Percentage volumetric doseBaseline up to 6 months

    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.