Recruiting

Hypoxia Imaging

Sponsor:

University of Utah

Code:

NCT06108089

Conditions

Head and Neck Cancer

Hypoxia

Magnetic Resonance Imaging

Cancer Neck

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

[18F]MISO-PET/CT

Study Details

Brief summary:

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

Head and Neck Cancer

Hypoxia

Magnetic Resonance Imaging

Cancer Neck

Study ID

NCT06108089

Start date

Jun 28, 2024

Status verified date

Aug, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Pregnant patients
  • Patients with claustrophobia
  • 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 with thyroid, skin, sinonasal, and salivary gland cancer.
  • Abnormal kidney function defined as estimated glomerular filtration rate (eGRF) < 30 mL/min/1.73 m2
  • Patients with uncontrolled diabetes
  • Patients who obtained outside FDG-PET/CT prior to initial treatment

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

[18F]MISO-PET/CT

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Olivia Pratt

(801)585-6142u0447662@utah.edu

Nousheen Alasti

(801)585-6142Nousheen.Alasti@hsc.utah.edu

Locations

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Olivia Pratt

801-585-6142u0447662@utah.edu

Principal Investigator:

Yoshimi Anzai, MD, MPH

More Information

Sponsor

University of Utah

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Keywords

  • hypoxia
  • precision medicine
  • imaging biomarker
  • prognosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2026-08-05.