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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

ConditionsClinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Head and Neck Squamous Cell CarcinomaHypopharyngeal Squamous Cell CarcinomaLaryngeal Squamous Cell CarcinomaOropharyngeal Squamous Cell CarcinomaStage III Hypopharyngeal Carcinoma AJCC v8Stage III Laryngeal Cancer AJCC v8Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage IVA Hypopharyngeal Carcinoma AJCC v8Stage IVA Laryngeal Cancer AJCC v8Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage IVB Hypopharyngeal Carcinoma AJCC v8Stage IVB Laryngeal Cancer AJCC v8Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University

About this trial

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. Radiation therapy to this region can affect the blood vessels in the neck that supply blood to the brain. F-18 NaF and F-18 FDG are contrast agents that can be used together with PET/CT imaging to visualize areas inside the body. A PET scan is a procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. A CT scan is a procedure that uses a computer linked to an x-ray machine to make a series of detailed pictures of areas inside the body. The pictures are taken from different angles and are used to create 3-dimensional views of tissues and organs. Combining a PET scan with a CT scan can help make the image easier to interpret. PET/CT scans are hybrid scanners that combine both modalities into a single scan during the same examination. Imaging with F-18 NaF PET/CT may be as effective or more effective than the standard F-18 FDG PET/CT for assessing the effects radiation therapy has on blood vessels in the neck in patients with head and neck cancers.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Computed Tomography

    Procedure/Surgery

    Undergo PET/CT

  • Fludeoxyglucose F-18

    Other intervention

    Given F-18 FDG

  • Intensity-Modulated Proton Therapy

    Procedure/Surgery

    Undergo IMPT

  • Intensity-Modulated Radiation Therapy

    Radiation

    Undergo IMRT

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET/CT

  • Sodium Fluoride F-18

    Drug

    Given IV

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Arm I (F-18 NaF PET/CT)Experimental treatment 5 interventions
Group B: Arm II (F-18 NaF PET/CT)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Radiation-induced vascular complications

Will compare the presence and extent of radiation therapy (RT)-induced vascular complications between the two treatment modalities. The average standardized uptake volume (SUV) max and mean of fludeoxyglucose F-18 (FDG)- and sodium fluoride F-18 (NaF)-positron emission tomography (PET)/computed tomography (CT) scans pre- and post RT will be computed. Will assess the change in average SUVmax and SUVmean of FDG- and NaF-PET/CT scans pre- and post-RT. Will also assess the difference in average SUV mean between proton and photon RT. Will assess the difference in change in SUV mean between intensity-modulated radiation therapy (IMRT) and intensity-modulated photon therapy (IMPT) using a two-sample independent t-test or the Wilcoxon rank sum test for each SUVmean/max. A multivariable linear regression model with a backward elimination approach will be used to test the effect of clinicopathological variables on the change in SUVmax.

Time frame
Prior to and after undergoing radiation therapy, up to 6 months
2

Radiation-induced vascular inflammation following IMRT or IMPT

Will evaluate the presence and extent of radiation-induced vascular inflammation following IMRT versus IMPT. Will determine the correlation between the actual radiation dose and radiation-induced vascular inflammation, measured by the average SUVmax/mean, and will be done using Pearson's correlation or Spearman's correlation analysis, as appropriate.

Time frame
Baseline up to 6 months
3

Percentage volumetric dose

The percentage volumetric dose will be recorded to determine the correlation between the actual radiation dose and the radiation-induced vascular inflammation, measured by the average SUVmax/mean, and will be done using Pearson's correlation or Spearman's correlation analysis, as appropriate.

Time frame
Baseline up to 6 months

Secondary outcomes

1

Total brain FDG uptake

Will assess the association of total brain FDG uptake between the two scanning methods (FDG and NaF PET/CT). The total brain FDG uptake pre- and post-RT will be measured. Will assess the association between the average SUVmax/mean difference of FDG- and NaF-PET/CT scans and the total brain FDG uptake. Will be performed using Pearson's correlation or Spearman's correlation analysis, as appropriate.

Time frame
Baseline up to 6 months

Other outcomes

Sponsors and contacts

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Emory University

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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