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Compares treatment options for Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal...
Official title 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
ClinicalTrials.gov ID: NCT06914999
What this study is testing
What is Sodium Fluoride F-18?
Sodium Fluoride F-18 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for clinical stage i hpv-mediated (p16-positive) oropharyngeal carcinoma ajcc v8.
Also referred to as 18 F-NaF, F-18 NaF.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Treatment with concurrent chemoradiotherapy per institutional standard of care at the discretion of Medical Oncology. RT is delivered per...
- Patients must give protocol-specific consent on an Institutional Review Board (IRB)-approved consent form prior to completion of protocol-specific...
- Women are eligible to participate in the study if they meet one of the following criteria:
You likely can't join 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...
- Patients who are receiving any other investigational agents or an investigational device within 21 days before administration of the F-18 NaF for the...
- Patients planned to receive any immunotherapy agent during their radiotherapy or in the interval between radiotherapy and post-RT PET/CT imaging
See the full eligibility 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...
- 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...
- 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
- 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...
- 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...
- Significant cardiovascular disease (eg, myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism) within 3 months prior to study entry; angina requiring therapy; symptomatic peripheral vascular...
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.