RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-06-28
Study Completion:2025-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06108089

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Patients are scheduled to undergo chemoradiotherapy or surgery
  3. * Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
  1. * Pregnant patients
  2. * Patients with claustrophobia
  3. * Patients with pacemaker, spinal stimulator, or cochlear implant that are not MR compatible or any other metallic objects in the body
  4. * Patients who had been treated for HNC, either surgery, radiation therapy, or chemotherapy
  5. * Patients with thyroid, skin, sinonasal, and salivary gland cancer.
  6. * Abnormal kidney function defined as estimated glomerular filtration rate (eGRF) \< 30 mL/min/1.73 m2
  7. * Patients with uncontrolled diabetes
  8. * Patients who obtained outside FDG-PET/CT prior to initial treatment

Contacts and Locations

Study Contact

Olivia Pratt
CONTACT
(801)585-6142
u0447662@utah.edu
Nousheen Alasti
CONTACT
(801)585-6142
Nousheen.Alasti@hsc.utah.edu

Principal Investigator

Yoshimi Anzai, M.D.
PRINCIPAL_INVESTIGATOR
University of Utah

Study Locations (Sites)

University of Utah
Salt Lake City, Utah, 84112
United States

Collaborators and Investigators

Sponsor: University of Utah

  • Yoshimi Anzai, M.D., PRINCIPAL_INVESTIGATOR, University of Utah

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-28
Study Completion Date2025-12-01

Study Record Updates

Study Start Date2024-06-28
Study Completion Date2025-12-01

Terms related to this study

Keywords Provided by Researchers

  • hypoxia
  • precision medicine
  • imaging biomarker
  • prognosis

Additional Relevant MeSH Terms

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