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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06108089
• Other study ID #: 107380
• Status: Not yet recruiting
• Start date: April 1, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: March 2024
• Source: University of Utah
• Contact: Suyi Nui
• Phone: 801-585-1021
• Email: Suyi.Niu[@]hsc.utah.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Neck
• Head and Neck Cancer
• Head and Neck Neoplasms
• Hypoxia
• Magnetic Resonance Imaging

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Huntsman Cancer Institute

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The correlation of hypoxia volume between hypoxia MR and IHC with hypoxia biomarkers	Percent volume of the hypoxic subregion measured on both hypoxia MR and IHC	1 year
Secondary	Response to chemoradiotherapy	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.	1 year