Comparing two imaging techniques for assessing blood vessel effects in head and neck cancer patients receiving radiation therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early phase I trial evaluates the effectiveness of sodium fluoride F-18 (F-18 NaF) PET/CT imaging compared to the standard fludeoxyglucose F-18 (F-18 FDG) PET/CT imaging in assessing radiation-induced vascular complications in patients with head and neck cancers. The study aims to determine the role of these imaging techniques in identifying vascular inflammation and its correlation with radiation dose received. Patients will undergo both imaging methods before and after radiation therapy to monitor changes in vascular health. The trial will also explore the impact of radiation-induced vascular inflammation on brain function.

Why it matters

Who can join: the full rules

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

Where it's running

• Emory University Hospital Midtown
  Atlanta, Georgia, United States Recruiting

Study contacts

• Principal investigator: Amol M Takalkar, MD, MS, MBA — Emory University
• Study coordinator: Amol M. Takalkar, MD, MS, MBA
• Email: amol.madan.takalkar@emory.edu
• Phone: 404-712-4843

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Camonsertib added to precise radiation therapy for recurrent head and neck cancer

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• Comparing radiation therapy alone or with cisplatin for advanced head and neck cancer after surgery

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• Adding chemotherapy or chemo-immunotherapy to standard salvage surgery for advanced head and neck cancer

  This trial tests whether giving chemotherapy alone or chemotherapy plus the immunotherapy cemiplimab before salvage surgery helps people with PD-L1–positive recurrent or persistent head and neck squamous cell carcinoma.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.