Clinical trial · Observational
Novel Hypoxia Imaging for Head and Neck Cancer: Imaging Phenotype for Personalized Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Neck | — | UNRESOLVED | — |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Hypoxia | — | UNRESOLVED | — |
| Magnetic Resonance Imaging | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18F]MISO-PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- patients treated with CRT
- description
- 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.
- interventionNames
- Diagnostic Test: [18F]MISO-PET/CT
- label
- patients treated with primary surgical resection.
- description
- 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.
- interventionNames
- Diagnostic Test: [18F]MISO-PET/CT
Primary outcomes (1)
- measure
- The correlation of hypoxia volume between hypoxia MR and F18-FMISO PET
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDRoberts 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. PMID 37030177