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

Study Visits:

If participant is found to be eligible to take part in this study, participant will have the
following tests and procedures performed.

If participant is receiving chemotherapy before radiation therapy, blood (about 3 teaspoons)
will be drawn for biomarker testing before participant starts chemotherapy and then before
each cycle of chemotherapy until participant starts radiation therapy.

For all participants, the following tests and procedures will be performed before participant
starts radiation therapy:

- Participant will have an MRI.

- Blood (about 3 teaspoons) will be drawn for biomarker testing.

- Participant will complete a questionnaire about participant's quality of life.
Completing this questionnaire should take about 5-10 minutes.

Treatment is given outside of the study, as recommended by participant's doctor. Taking part
in the study will not affect participant's treatment plan.

After participant's first radiation treatment, blood (about 3 teaspoons) will be drawn for
biomarker testing.

Every week while participant is receiving radiation therapy:

- Participant will have a physical exam and endoscopy.

- Blood (about 3 teaspoons) will be drawn for routine and biomarker testing.

Every week during radiation therapy:

- Participant will have an MRI. This may be done as often as 1 time a day during radiation
therapy if participant is having image-guided radiation therapy (GRT).

- Participant will complete the quality-of-life questionnaire.

Wherever possible, blood samples will be collected at the same time as routine blood draws
and/or when a catheter (needle and tube) is placed. However, if a blood draw is not planned,
one will be scheduled for this study.

Length of Study:

Participation on the study will be over after the follow-up visit. Participant will be taken
off study early if radiation treatment is stopped early.

Follow-up:

One (1) time a week for as long as needed during routine follow-up, participant will complete
the quality-of-life questionnaire.

At 2-3 months after treatment:

- Participant will have a physical exam and endoscopy.

- Blood (about 3 teaspoons) will be drawn for routine and biomarker testing.

- Participant will have a CT, MRI, and PET/CT scan to check the status of the disease.

Inclusion Criteria:

1. 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.

2. Age ≥18 years

3. No distant metastases, based on routine staging workup.

4. Consent for blood collection for biomarker analysis

5. No head and neck surgery of the primary tumor or lymph nodes except for incisional or
excisional biopsies

6. Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2.

7. Dispositioned to curative intent radiotherapy

8. For females of child-bearing age, a negative pregnancy test

Exclusion Criteria:

1. Previous radiation treatment for head and neck mucosal primary cancers within the past
5 years (i.e. oropharynx, nasopharynx, hypopharynx, larynx, and oral cavity)

2. Pregnant or breast-feeding females

3. Contraindications to MR imaging (e.g. implanted metallic prostheses, defibrillators,
or stimulators)

4. History of claustrophobia

5. Contraindications to gadolinium contrast (e.g. kidney dysfunction)