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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT06914999
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
  • Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
  • Clinical Stage III HPV-Mediated (p16-Positive) 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
  • Stage III Laryngeal Cancer AJCC v8
  • Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8
  • Stage IVA Hypopharyngeal Carcinoma AJCC v8
  • Stage IVA Laryngeal Cancer AJCC v8
  • Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8
  • Stage IVB Hypopharyngeal Carcinoma AJCC v8
  • Stage IVB Laryngeal Cancer AJCC v8
  • Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Computed Tomography — PROCEDURE
    Undergo PET/CT
  • Fludeoxyglucose F-18 — OTHER
    Given F-18 FDG
  • Intensity-Modulated Proton Therapy — PROCEDURE
    Undergo IMPT
  • Intensity-Modulated Radiation Therapy — RADIATION
    Undergo IMRT
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT
  • Sodium Fluoride F-18 — DRUG
    Given IV

Study Details

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.

Key Dates

Start date
Dec 3, 2024
Status verified
Oct 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Arm I (F-18 NaF PET/CT)
    Patients receive F-18 NaF IV and undergo PET/CT within 28 days of each SOC F-18 FDG PET/CT on study, once prior to initiation of SOC IMRT and once 12 weeks after completion of SOC IMRT.
  • Experimental: Arm II (F-18 NaF PET/CT)
    Patients receive F-18 NaF IV and undergo PET/CT within 28 days of each SOC F-18 FDG PET/CT on study, once prior to initiation of SOC IMPT and once 12 weeks after completion of SOC IMPT.

Primary Outcome Measure

Radiation-induced vascular complications [ Time Frame: Prior to and after undergoing radiation therapy, up to 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Emory University Hospital MidtownAtlantaGeorgia30308
Nashwa M. Jarkas
[email protected]
404-727-2193
Amol M. Takalkar, MD, MS, MBA, FACNM (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Emory University Hospital Midtown· Atlanta, GA

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