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NCT Number: NCT06108089

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Utah

Salt Lake City, Utah, 84112, United States

Location status: Recruiting

Location contact

Olivia Pratt

CONTACT

[email protected]

801-585-6142

Yoshimi Anzai, MD, MPH

PRINCIPAL_INVESTIGATOR

About this study

The objectives of this feasibility study are; 1) To obtain pilot data for a full-scale study and measure the distribution of parameters of the hypoxia MR (perfusion, diffusion, oxygenation, and acidosis) imaging, 2) To assess association of various hypoxia MR metrics with outcome, response to chemoradiotherapy (CRT) determined by 3 months post CRT FDG-PET/CT. 3) The metrics developed on hypoxia MRI wil be validated against F-18 FMISO-PET/CT and whole specimen IHC (immunohistochemistry). The data obtained from this pilot study will allow us to measure the effect size (difference in hypoxia MR metrics between responder and non-responder) for a larger, full-scale diagnostic study in the future, as well as to determine which hypoxia MR parameters have a strong association with desired outcome (response to CRT) in the future study.

The long-term objective of this research is to evaluate hypoxia MR phenotype that can be incorporated into treatment planning for IMRT (intensity-modulated radiotherapy), identify subregions of tumor hypoxia, and predict response to chemoradiotherapy (CRT) in newly diagnosed head and neck squamous cell carcinoma. The investigators will develop hypoxia MRI using a widely available MRI platform that allows broad patients access to novel hypoxia MRI. The investigators will evaluate the accuracy of the prediction of response to CRT using quantitative variables derived from hypoxia MR at the baseline as well as early interval changes between the baseline and 2 weeks of intra-treatment MR scans. Response to CRT will be determined by 3 months post-treatment FDG-PET/CT.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[18F]MISO-PET/CT

Diagnostic Test

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

Primary outcomes

  1. The correlation of hypoxia volume between hypoxia MR and F18-FMISO PET

    Time frame: 1 year

    the correlation of the percentages of hypoxia volume on hypoxia MR and F18-FMISO PET as the standard references

Secondary outcomes

  1. The correlation of hypoxia volume between hypoxia MR and IHC with hypoxia biomarkers

    Time frame: 1 year

    Percent volume of the hypoxic subregion measured on both hypoxia MR and IHC

  2. Response to chemoradiotherapy

    Time frame: 1 year

    Correlation with hypoxia phenotype identified on hypoxia MR with response to chemoradiotherapy determined by pre and 3 month post treatment FDG-PET/CT as the standard clinical practice. Those patients with equivocal FDG-PET/CT will be followed clinically and conventional CT or MR imaging up to 1 year.

Study contacts

Contact information is provided by the study sponsor or research team.

Nousheen Alasti

CONTACT

[email protected]

(801)585-6142

Olivia Pratt

CONTACT

[email protected]

(801)585-6142

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • Huntsman Cancer Institute

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 30, 2023
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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