Status:
RECRUITING
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
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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\...
Detailed Description
PRIMARY OBJECTIVES: I. 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....
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
Key Trial Info
Start Date :
December 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06914999
Start Date
December 3 2024
End Date
August 31 2027
Last Update
October 22 2025
Active Locations (1)
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1
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308