NCT06108089 Novel Hypoxia Imaging for Head and Neck Cancer: Imaging Phenotype for Personalized Treatment
| NCT ID | NCT06108089 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Utah |
| Condition | Head and Neck Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-06-28 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2024-06-28 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Yoshimi Anzai, M.D.
PRINCIPAL INVESTIGATOR
University of Utah
Frequently Asked Questions
Who can join the NCT06108089 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06108089 currently recruiting?
Yes, NCT06108089 is actively recruiting participants. Contact the research team at u0447662@utah.edu for enrollment information.
Where is the NCT06108089 trial being conducted?
This trial is being conducted at Salt Lake City, United States.
Who is sponsoring the NCT06108089 clinical trial?
NCT06108089 is sponsored by University of Utah. The principal investigator is Yoshimi Anzai, M.D. at University of Utah. The trial plans to enroll 20 participants.
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