Actively Recruiting

Age: 18Years +
All Genders
NCT06108089

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

Led by University of Utah · Updated on 2024-08-12

20

Participants Needed

1

Research Sites

74 weeks

Total Duration

On this page

Sponsors

U

University of Utah

Lead Sponsor

H

Huntsman Cancer Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Newly diagnosed head and neck squamous cell carcinoma confirmed by biopsy or fine needle aspiration from the oral cavity, larynx, hypopharynx, nasopharynx, or oropharynx
  • Scheduled to undergo chemoradiotherapy or surgery
  • Able and willing to provide informed consent according to federal and institutional guidelines
Not Eligible

You will not qualify if you...

  • Pregnant patients
  • Claustrophobia
  • Presence of pacemaker, spinal stimulator, cochlear implant not compatible with MRI, or any other metallic objects in the body
  • Prior treatment for head and neck cancer including surgery, radiation, or chemotherapy
  • Thyroid, skin, sinonasal, or salivary gland cancer
  • Abnormal kidney function with estimated glomerular filtration rate below 30 mL/min/1.73 m2
  • Uncontrolled diabetes
  • Patients who had FDG-PET/CT outside the study before initial treatment

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Utah

Salt Lake City, Utah, United States, 84112

Actively Recruiting

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Research Team

O

Olivia Pratt

CONTACT

N

Nousheen Alasti

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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