AzTrials
AzTrials

Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Early 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

A Early Phase 1 study testing Computed Tomography, Fludeoxyglucose F-18 and Intensity-Modulated Proton Therapy in people with Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, run by Emory University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Computed Tomography, Fludeoxyglucose F-18 and Intensity-Modulated Proton Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
3 Dec 2024to 31 Aug 2027
Phase
Early Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

404-712-4843

amol.madan.takalkar@emory.edu

United States1 site, 1 recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

    Nashwa M. Jarkas, 404-727-2193, nashwa.jarkas@emory.edu

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

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
Computed Tomography, Fludeoxyglucose F-18, Intensity-Modulated Proton Therapy, Intensity-Modulated Radiation Therapy, Positron Emission Tomography
Medical subject headings
Oropharyngeal Neoplasms, Squamous Cell Carcinoma of Head and Neck, Hypopharyngeal Neoplasms, Laryngeal Neoplasms, Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo PET/CT

  • Fludeoxyglucose F-18Other

    Also called 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18

    Given F-18 FDG

  • Intensity-Modulated Proton TherapyProcedure or surgery

    Also called IMPT

    Undergo IMPT

  • Intensity-Modulated Radiation TherapyRadiation

    Also called IMRT, Intensity modulated radiation therapy (procedure), Intensity Modulated RT, Intensity-Modulated Radiotherapy

    Undergo IMRT

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET/CT

  • Sodium Fluoride F-18Drug

    Also called 18 F-NaF, F-18 NaF, Fluorine F 18 Sodium Fluoride, NaF F18

    Given IV

Study groups in NCT06914999
Study groupRoleWhat they receive
Arm I (F-18 NaF PET/CT)ExperimentalPatients 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.
Receives: Procedure: Computed Tomography; Other: Fludeoxyglucose F-18; Radiation: Intensity-Modulated Radiation Therapy; Procedure: Positron Emission Tomography; Drug: Sodium Fluoride F-18
Arm II (F-18 NaF PET/CT)ExperimentalPatients 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.
Receives: Procedure: Computed Tomography; Other: Fludeoxyglucose F-18; Procedure: Intensity-Modulated Proton Therapy; Procedure: Positron Emission Tomography; Drug: Sodium Fluoride F-18

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Radiation-induced vascular complications

    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.

    Measured: Prior to and after undergoing radiation therapy, up to 6 months

  2. Radiation-induced vascular inflammation following IMRT or IMPT

    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.

    Measured: Baseline up to 6 months

  3. Percentage volumetric dose

    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.

    Measured: Baseline up to 6 months

Secondary outcomes (1)

  1. Total brain FDG uptake

    Will assess the association of total brain FDG uptake between the two scanning methods (FDG and NaF PET/CT). The total brain FDG uptake pre- and post-RT will be measured. Will assess the association between the average SUVmax/mean difference of FDG- and NaF-PET/CT scans and the total brain FDG uptake. Will be performed using Pearson's correlation or Spearman's correlation analysis, as appropriate.

    Measured: Baseline up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2025
  2. Study start3 Dec 2024
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06914999
Sponsor's protocol ID
STUDY00008261
Other IDs
NCI-2025-00404, STUDY00008261, H-N Ca Patients, P30CA138292
Status last verified
Oct 2025
First submitted
1 Apr 2025
Last updated
22 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in