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

NCT06108089 | Recruiting DMC

• 1 other identifier: 107380
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

hypoxia; precision medicine; imaging biomarker; prognosis

Outcome Measures

Primary Outcomes (1)

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

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

  1 year

Secondary Outcomes (2)

• The correlation of hypoxia volume between hypoxia MR and IHC with hypoxia biomarkers

  1 year

• Response to chemoradiotherapy

  1 year

Study Arms (2)

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.

Diagnostic Test: [18F]MISO-PET/CT

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.

Diagnostic Test: [18F]MISO-PET/CT

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.

patients treated with CRT; patients treated with primary surgical resection.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

1. Patients with newly diagnosed advanced-stage HNC with a primary tumor larger than 3 cm that are treated with CRT (chemoradiotherapy) 2. Patients with newly diagnosed localized HNC that are primarily treated with surgical resection for whole specimen IHC

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead
• Huntsman Cancer Institute: collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

Related Publications (1)

• Roberts J, Kim SE, Kholmovski EG, Hitchcock Y, Richards TJ, Anzai Y. The arterial input function: Spatial dependence within the imaging volume and its influence on 3D quantitative dynamic contrast-enhanced MRI for head and neck cancer. Magn Reson Imaging. 2023 Sep;101:40-46. doi: 10.1016/j.mri.2023.03.016. Epub 2023 Apr 7.

  PMID: 37030177 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms; Hypoxia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yoshimi Anzai, M.D.

  University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivia Pratt

CONTACT

(801)585-6142; u0447662@utah.edu

Nousheen Alasti

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Professor of Radiology

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 30, 2023
• Study Start: June 28, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 12, 2024

Record last verified: 2024-08

Locations

US (1)