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

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

This study is testing if a new type of imaging can better spot blood vessel problems in head and neck cancer patients getting radiation therapy compared to the usual imaging method.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Emory University (other)
• Drugs / interventions: chemotherapy, immunotherapy, Radiation
• Locations: 1 site (Atlanta, Georgia)
• Trial ID: NCT06914999 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with clinical stage I-III HPV-associated or stage III-IVb HPV-negative squamous cell carcinoma of the head and neck receiving radiation therapy.

Not a fit: Patients with non-squamous cell carcinomas or those not receiving radiation therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved imaging techniques that better assess vascular complications in head and neck cancer patients, potentially enhancing treatment outcomes.

How similar studies have performed: Other studies have shown promise in using advanced imaging techniques for assessing treatment effects in cancer patients, suggesting potential success for this approach.

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

Where this trial is running

Atlanta, Georgia

• Emory University Hospital Midtown — Atlanta, Georgia, United States (RECRUITING)

Study contacts

• Principal investigator: Amol M Takalkar, MD, MS, MBA, FACNM — Emory University
• Study coordinator: Amol M. Takalkar, MD, MS, MBA, FACNM

Conditions: Clinical Stage I HPV-Mediated Oropharyngeal Carcinoma AJCC v8, Clinical Stage II HPV-Mediated Oropharyngeal Carcinoma AJCC v8, Clinical Stage III HPV-Mediated Oropharyngeal Carcinoma AJCC v8, Head and Neck Squamous Cell Carcinoma, Hypopharyngeal Squamous Cell Carcinoma, Laryngeal Squamous Cell Carcinoma, Oropharyngeal Squamous Cell Carcinoma, Stage III Hypopharyngeal Carcinoma AJCC v8