Novel Hypoxia Imaging for Head and Neck Cancer: Imaging Phenotype for Personalized Treatment

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT06108089
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • [18F]MISO-PET/CT — DIAGNOSTIC_TEST
    18F\]MISO-PET/CT will be acquired in each patient as the standard of references of tumor hypoxia.

Study Details

Tumor hypoxia is one of the physiological factors for treatment resistance and likely contributes to poor overall survival among patients with head and neck cancer (HNC). Identifying hypoxic features of HNC may allow the personalizing treatment plan. The investigators propose multiparametric Hypoxia MR (HMR) imaging using diffusion, perfusion, and oxygenation as non-invasive, in-vivo imaging components of a hypoxia phenotype. Assessing the hypoxia phenotypes' expression will be critically important for characterizing and predicting CRT response among patients with advanced HNC. A prospective cohort study will be conducted used multiparametric MR (MPMR) imaging correlated with treatment response assessed by 3 months fluorodeoxyglucose-positron emission tomography (FDG-PET). The image analysis approach will be developed to incorporate FDG-PET and quantitative MRI characteristics of tumor (ADC, oxygen-enhanced T1 and T2\* maps, and volume transfer constant (Ktrans) to facilitate 3D visualization of multiparametric information. This proposed study's overarching goal is to develop and validate multiparametric HMR imaging using 18F - (fluoromisonidazole) FMISO-PET and immunohistochemistry (IHC) as the standard of references.

Key Dates

Start date
Jun 28, 2024
Status verified
Aug 2024
Primary completion
Dec 1, 2025
Completion
Dec 1, 2025

Study Design

Enrollment
20 participants (estimated)

Arms

  • Arm: patients treated with CRT
    Two hypoxia MR scans will be performed, one at pre-treatment and one at 2 weeks into CRT. Patients receive FMISO-PET/CT scans prior to the initiation of CRT.
  • Arm: patients treated with primary surgical resection.
    Hypoxia MR scan and FMISO-PET/CT scan will be performed prior to the treatment (surgery). Surgical specimen of excised primary tumor will undergo IHC staining.

Primary Outcome Measure

The correlation of hypoxia volume between hypoxia MR and F18-FMISO PET [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of UtahSalt Lake CityUtah84112
Olivia Pratt
[email protected]
801-585-6142
Yoshimi Anzai, MD, MPH (PRINCIPAL_INVESTIGATOR)

Find similar trials in Salt Lake City, UT

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
University of Utah· Salt Lake City, UT

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