Diffusion MRI for the Assessment of Response during Chemoradiation Treatment in Patients with Head and Neck Squamous Cell Cancer That Is Metastatic to the Lymph Nodes

Status: closed to accrual

This phase IV trial develops magnetic resonance imaging (MRI) techniques to assess the response of the chemotherapy-radiation (chemoradiation) treatment in patients with head and neck squamous cell cancer that has spread to the lymph nodes (metastatic). Positron emission tomography (PET) uses radiation and MRI uses magnetic fields to create images to provide information about the structure, function, and metabolism (level of activity and use of nutrients) of different tissues in the body. The purpose of this trial is to improve the way in which the treatment response of tumors is assessed, which may benefit future patients with head and neck squamous cell cancer.

Inclusion Criteria

ARM I: Treatment-naive head and neck squamous cell carcinoma (HNSCC) patients with metastatic lymph nodes prior to surgery or chemoradiation therapy
ARM I: Age 18 or older
ARM I: Subjects will be asked to verbalize understanding of the key elements, for non-English speaking patients, institutional translation services will be utilized
ARM II: Treatment-naive HNSCC patients with metastatic lymph nodes who will undergo standard-of-care chemoradiation therapy
ARM II: Age 18 or older
ARM II: Subjects will be asked to verbalize understanding of the key elements, for non-English speaking patients, institutional translation services will be utilized

Exclusion Criteria

ARM I: Subjects without capacity to consent will not be enrolled
ARM II: Subjects without capacity to consent will not be enrolled
Subjects who have the following contraindications to MRI: * Electrical implants such as cardiac pacemakers or perfusion pumps * Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial heart, valves with steel parts, metal fragments, shrapnel, bullets, tattoos near the eye, or steel implants * History of seizures * Patients with glomerular filtration rate (GFR) < 15 ml/min/1.73m^2 or who are on dialysis will be excluded from the study
Subjects who are pregnant

PRIMARY OBJECTIVES:

I. To optimize diffusion MRI methods for assessment of cell viability, metabolism and perfusion. (Arm I)

II. To assess the feasibility of using diffusion MRI metrics at the early stages of treatment for prediction of chemoradiation treatment response. (Arm II)

OUTLINE: Patients are assigned to 1 of 2 arms.

ARM I: Patients receive fludeoxyglucose F-18 intravenously (IV) and gadobutrol IV and then undergo a PET/diffusion MRI (dMRI) scan over 1 hour at baseline (prior to any treatment). Within 3 days, patients undergo a dMRI scan over 1 hour.

ARM II: Patients receive gadobutrol IV and then undergo a dMRI scan over 1 hour at baseline. Patients then repeat the same dMRI scan over 1 hour at 2, 4, and 6 weeks during standard of care chemoradiation therapy.

After completion of study, patients are followed up periodically.

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Diffusion MRI for the Assessment of Response during Chemoradiation Treatment in Patients with Head and Neck Squamous Cell Cancer That Is Metastatic to the Lymph Nodes

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