Magnetic Resonance (MR) Imaging & Blood Biomarkers for Head and Neck Cancer

Study Overview
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Brief Summary
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The goal of this research study is to find out if using additional MRIs and biomarker testing can help researchers learn to predict how the tumor may change during radiation therapy. Biomarkers are found in the blood/tissue and may be related to participant's reaction to treatment. Biomarker testing in the study may include genetic biomarkers. This is an investigational study. MRIs on this study are performed using FDA-approved and commercially available methods. Having added scans and blood tests is investigational. Up to 100 participants will be enrolled in this study (up to 80 patients and up to 20 healthy volunteers in another part of the study). All will take part at MD Anderson.

Detailed Description
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PRIMARY OBJECTIVES: I. To assess the prognostic value of pretreatment volumetric tumor growth velocity (TGV), weekly tumor kinetics (TK), and blood biomarkers of mucosal head and neck cancers during radiation therapy (RT), using magnetic resonance imaging (MRI). SECONDARY OBJECTIVES: I. To assess functional imaging kinetics as a marker of tumor locoregional control. II. To correlate blood biomarkers with tumor kinetics during treatment. III. To generate preliminary data for future trials. OUTLINE: Patients undergo MRI scans and collection of blood samples for biomarker testing pre-radiation therapy, weekly during radiation therapy, and at 2-3 months post-radiation therapy. After completion of study, patients are followed up weekly.

Official Title
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Quantification of Tumor Imaging Kinetics and Blood Biomarkers in Head and Neck Cancer Patients

Conditions
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Cutaneous Squamous Cell Carcinoma of the Head and Neck, Healthy Subject, Head and Neck Cancer

Intervention / Treatment
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* Procedure: Biospecimen Collection
* Procedure: Magnetic Resonance Imaging
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Biopsy proven diagnosis of squamous cell carcinoma (SCC) of head and neck mucosa. Clinical evidence should be documented, and may consist of imaging, endoscopic evaluation, palpation, and should be sufficient to estimate the size of the primary for purposes of T staging No distant metastases, based on routine staging workup Consent for blood collection for biomarker analysis No head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2 Dispositioned to curative intent radiotherapy For females of child-bearing age, a negative pregnancy test Exclusion Criteria: Previous radiation treatment for head and neck mucosal primary cancers within the past 5 years (i.e. oropharynx, nasopharynx, hypopharynx, larynx, and oral cavity) Pregnant or breast-feeding females Contraindications to magnetic resonance (MR) imaging (e.g. implanted metallic prostheses, defibrillators, or stimulators) History of claustrophobia Contraindications to gadolinium contrast (e.g. kidney dysfunction)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (MRI, blood sample collection)<br>Patients undergo MRI scans and collection of blood samples for biomarker testing pre-radiation therapy, weekly during radiation therapy, and at 2-3 months post-radiation therapy. | Procedure: Biospecimen Collection<br>* Undergo collection of blood samples<br>Procedure: Magnetic Resonance Imaging<br>* Undergo MRI scan<br>* Other names: Nuclear Magnetic Resonance Imaging;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor growth velocity (TGV) | TGV is the calculated daily increase in tumor size from diagnosis to immediately before first radiotherapy (RT) treatment as measured via magnetic resonance imaging (MRI). Will use graphs and descriptive statistics to evaluate the relationship between TGV, tumor kinetics (TK), and circulating tumor cells (CTCs) with response. | Baseline and up to 2-3 months after completion of radiation therapy | 
| Change in TK | Tumor kinetics is the weekly decrease or increase in tumor volume after initiation of radiotherapy, evaluated using MRI. Will also use generalized linear mixed models (GLMMs) to evaluate TK over time and to assess whether a difference exists between patients with complete response (CR) and those without CR. Will use graphs and descriptive statistics to evaluate the relationship between TGV, TK, and CTCs with response. | Baseline up to 2-3 months after radiation therapy | 
| Change in Blood Biomarkers of Mucosal Head and Neck Cancers During Radiation Therapy (RT) | Will use GLMMs to evaluate CTCs over time and to assess whether a difference exists between patients with CR and those without CR. Will use graphs and descriptive statistics to evaluate the relationship between TGV, TK, and CTCs with response. | Baseline and up to 2-3 months after completion radiation treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Locoregional control | Locoregional control is defined as 2-year disease-free survival (DFS). Proportional hazards models will be created to examine the trajectory and intercept of TK and CTCs during radiation therapy with DFS. Time-varying covariates longitudinal modeling will be used to assess the relationship between TK and CTCs. | From date of first treatment to date of death, disease progression or recurrence, whichever occurs first, assessed up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Head and Neck Cancer, Magnetic resonance imaging, MRI, Biomarker testing, Blood draws, Questionnaires, Surveys