Optimized Diffusion-Weighted Imaging for the Evaluation of Post-Treatment Squamous Cell Carcinoma in the Neck: Comparative Study With FDG PET/CT

Study Overview
=================
Brief Summary
-----------------
The investigators propose a longitudinal study evaluating post-treatment changes in patients with squamous cell carcinoma (SCC) of the neck using an innovative optimized diffusion-weighted imaging (DWI) pulse sequence to identify more accurately recurrent tumors as well as early non-responders to therapy.

Official Title
-----------------
Optimized Diffusion-Weighted Imaging for the Evaluation of Post-Treatment Squamous Cell Carcinoma in the Neck: Comparative Study With FDG PET/CT

Conditions
-----------------
Squamous Cell Carcinoma

Intervention / Treatment
-----------------
* Device: Diffusion-weighted imaging magnetic resonance imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically-proven newly diagnosis or recurrence as indicated by tissue diagnosis of T3 or T4 squamous cell carcinoma of the head and neck Must have had or be scheduled for standard-of-care surgical resection, radiation, and/or chemo-radiation of the diagnosed squamous cell carcinoma of the head and neck At least 18 years of age Patient must be able to understand and willing to sign a written informed consent document. Exclusion Criteria: Contraindications to MRI, including: MRI-incompatible implantable devices severe claustrophobia; and Pregnant and/or breastfeeding, with women of childbearing potential having a negative urine or serum pregnancy test

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DWI MRI<br>-The patients will undergo an optimized research neck DWI MRI, up to 3 weeks post-treatment and then a standard-of-care 3-month post-treatment FDG PET/CT examination. | Device: Diffusion-weighted imaging magnetic resonance imaging<br>* The research MRI study of the head and neck will be performed on a Siemens 3T MRI Scanner system<br>* Other names: DWI MRI;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apparent diffusion coefficient mean (ADCmean) | ADC=measure of the magnitude of diffusion (of water molecules) within tissue The primary tumor, suspicious lesion, and/or area of post-treatment change will be identified in anatomical images & then outlined in the ADC sequence, excluding areas of cystic change and necrosis. If there are multiple lesions, only the dominant lesion with the lowest ADC will be used for analysis A histogram analysis method will examine the distribution of ADC values within each region of interest (ROI) ADCmean will describe distribution of ADC measurements in tumor/non-tumor tissues & independent sample t-test will compare ADC measurements between the 2 groups | 2-3 weeks post-standard of care treatment | 
| Apparent diffusion coefficient lowest value in a tumor (ADCmin) | ADC=measure of the magnitude of diffusion (of water molecules) within tissue The primary tumor, suspicious lesion, and/or area of post-treatment change will be identified in anatomical images & then outlined in the ADC sequence, excluding areas of cystic change and necrosis. If there are multiple lesions, only the dominant lesion with the lowest ADC will be used for analysis A histogram analysis method will examine the distribution of ADC values within each region of interest (ROI) ADCmin will describe distribution of ADC measurements in tumor/non-tumor tissues & independent sample t-test will compare ADC measurements between the 2 groups | 2-3 weeks post-standard of care treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of non-responders to treatment as measured by DWI MRI as compared to the number of non-responders to treatment as measured by FDG PET/CT |  | 2-3 weeks post-standard of care treatment |