Novel Hypoxia Imaging for Head and Neck Cancer: Imaging Phenotype for Personalized Treatment
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Utah
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
1. Patients with newly diagnosed advanced-stage HNC with a primary tumor larger than 3 cm that are treated with CRT (chemoradiotherapy) 2. Patients with newly diagnosed localized HNC that are primarily treated with surgical resection for whole specimen IHC
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
[18F]MISO-PET/CT
Diagnostic test18F\]MISO-PET/CT will be acquired in each patient as the standard of references of tumor hypoxia.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: patients treated with CRT1 intervention
Group B: patients treated with primary surgical resection.1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
1 yearSecondary outcomes
1
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
Time frame
1 year2
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.
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Utah
Lead sponsor
Huntsman Cancer Institute
Collaborator
Source ClinicalTrials.gov