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

Launched by EMORY UNIVERSITY · Apr 1, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new type of imaging test called F-18 NaF PET/CT, which may help doctors better assess how radiation therapy affects blood vessels in the neck of patients with head and neck cancers. The standard imaging test currently used is called F-18 FDG PET/CT. By comparing these two imaging methods, researchers hope to find out if the new test can provide more accurate information about any vascular complications that may arise from radiation treatment.

To participate in this trial, patients need to be 18 years or older and have specific types of head and neck cancers that are at certain stages. They must also be receiving radiation therapy as part of their treatment plan. Participants will receive both imaging tests and will be monitored to see how effective each is in showing changes in the blood vessels after radiation therapy. Importantly, the trial is still recruiting patients, and those interested should discuss with their doctors to see if they qualify and learn more about what being part of the study entails.

Gender

ALL

Eligibility criteria

• 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