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

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

NCT ID: NCT06108089

Condition: Head and Neck Cancer
Hypoxia
Magnetic Resonance Imaging
Cancer Neck

Conditions: Official terms:
Head and Neck Neoplasms
Hypoxia

Conditions: Keywords:
hypoxia
precision medicine
imaging biomarker
prognosis

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: [18F]MISO-PET/CT
Description: 18F]MISO-PET/CT will be acquired in each patient as the standard of references of tumor hypoxia.
Arm group label: patients treated with CRT
Arm group label: patients treated with primary surgical resection.

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.

Detailed description: 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.

Criteria for eligibility:

Study pop:
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

Sampling method: Probability Sample
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Utah

Address:
City: Salt Lake City
Zip: 84112
Country: United States

Status: Recruiting

Contact:
Last name: Olivia Pratt

Phone: 801-585-6142
Email: u0447662@utah.edu

Investigator:
Last name: Yoshimi Anzai, MD, MPH
Email: Principal Investigator

Start date: June 28, 2024

Completion date: December 1, 2025

Lead sponsor:
Agency: University of Utah
Agency class: Other

Collaborator:
Agency: Huntsman Cancer Institute
Agency class: Other

Source: University of Utah

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06108089