Recruiting
Early Phase 1

F-18 NaF PET/CT vs. F-18 FDG PET/CT

Sponsor:

Emory University

Code:

NCT06914999

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Computed Tomography

Fludeoxyglucose F-18

Intensity-Modulated Proton Therapy

Intensity-Modulated Radiation Therapy

Positron Emission Tomography

Study Details

Brief 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.

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

Study ID

NCT06914999

Start date

Dec 3, 2024

Status verified date

Oct, 2025

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Arm I (F-18 NaF PET/CT)

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 IMRT and once 12 weeks after completion of SOC IMRT.

experimental: Arm II (F-18 NaF PET/CT)

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 IMPT and once 12 weeks after completion of SOC IMPT.

Interventions

Computed Tomography

Undergo PET/CT

Fludeoxyglucose F-18

Given F-18 FDG

Intensity-Modulated Proton Therapy

Undergo IMPT

Intensity-Modulated Radiation Therapy

Undergo IMRT

Positron Emission Tomography

Undergo PET/CT

Sodium Fluoride F-18

Given IV

Primary outcome measure

  • Radiation-induced vascular complications [ Time Frame: Prior to and after undergoing radiation therapy, up to 6 months ]
  • Radiation-induced vascular inflammation following IMRT or IMPT [ Time Frame: Baseline up to 6 months ]
  • Percentage volumetric dose [ Time Frame: Baseline up to 6 months ]

Central Contacts and Locations

Central contacts

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

404-712-4843amol.madan.takalkar@emory.edu

Locations

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Nashwa M. Jarkas

404-727-2193nashwa.jarkas@emory.edu

Principal Investigator:

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

More Information

Sponsor

Emory University

Last update posted

Oct 22, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2025-10-22.