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
4 other identifiers
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Dec 2024
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 3, 2024
CompletedFirst Submitted
Initial submission to the registry
April 1, 2025
CompletedFirst Posted
Study publicly available on registry
April 7, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
October 22, 2025
October 1, 2025
1.7 years
April 1, 2025
October 20, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
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.
Prior to and after undergoing radiation therapy, up to 6 months
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.
Baseline up to 6 months
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.
Baseline up to 6 months
Secondary Outcomes (1)
Total brain FDG uptake
Baseline up to 6 months
Study Arms (2)
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.
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.
Interventions
Undergo PET/CT
Given F-18 FDG
Undergo IMRT
Undergo PET/CT
Given IV
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amol M Takalkar, MD, MS, MBA, FACNM
Emory University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Masking Details
- For the purposes of this study, will contour the ascending aorta, arch of the aorta, carotid arteries, and descending aorta but these structures will not be a part of the treatment planning process and will be blinded to the treating physician.
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 1, 2025
First Posted
April 7, 2025
Study Start
December 3, 2024
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 31, 2027
Last Updated
October 22, 2025
Record last verified: 2025-10