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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Utah
University of Utah
RECRUITING
Salt Lake City
Contact Information
Primary
Olivia Pratt
u0447662@utah.edu
(801)585-6142
Backup
Nousheen Alasti
Nousheen.Alasti@hsc.utah.edu
(801)585-6142
Time Frame
Start Date: 2024-06-28
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 20
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of Utah
Collaborators: Huntsman Cancer Institute

This content was sourced from clinicaltrials.gov