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NCT06108089Recruiting

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

Source: ClinicalTrials.gov · Last updated 5 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
20 (estimated)
First submitted
5 Oct 2023
Start date
28 Jun 2024
Primary completion date
1 Dec 2027
Lead sponsor
University of Utah
NCT number
NCT06108089

What you commit to

  • Study type: Observational
  • Planned participants: 20
  • From 28 Jun 2024 to the primary completion date, 1 Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with pacemaker, spinal stimulator, or cochlear implant that are not MR compatible or any other metallic objects in the body
  • Patients who had been treated for HNC, either surgery, radiation therapy, or chemotherapy
  • Patients who obtained outside FDG-PET/CT prior to initial treatment

Other illness

  • Patients with thyroid, skin, sinonasal, and salivary gland cancer.
  • Patients with uncontrolled diabetes

Other

  • Pregnant patients
  • Patients with claustrophobia
  • Abnormal kidney function defined as estimated glomerular filtration rate (eGRF) \< 30 mL/min/1.73 m2

Who the study is looking for

  • Newly diagnosed HNSCC (head and neck squamous cell carcinoma) by biopsy or fine needle aspiration originating from the oral cavity, larynx, hypopharynx, nasopharynx, and oropharynx
  • Patients are scheduled to undergo chemoradiotherapy or surgery
  • Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Utah
Coordinator of this site? Confirm its status
Salt Lake CityUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.