Total-Body FDG PET for Radiotherapy Response Assessment in Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
The overall goal of this research study is to understand how 18F-fluorodeoxyglucose (FDG), a radioactive sugar behaves in head and neck cancer (HNC) and inflammation immediately following injection and at many hours post-injection, with the world's first total-body positron emission tomography (PET)/computed tomography (CT) scanner (EXPLORER).

Official Title
-----------------
Characterizing Dynamics of FDG Uptake With Total-Body PET for Response Assessment in Radiotherapy for Head and Neck Cancer

Conditions
-----------------
Head and Neck Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: Total Body PET/CT Imagin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage II-IVa (American Joint Committee on Cancer, 8th edition) OC who are planned for RT (≥60 Gy) as per routine clinical standard. Patient must be ≥18 years of age. Willing and able to lay motionless in a supine position for up to 60 minutes Patient must be able to provide study specific informed consent prior to study entry. Patient must be able to adhere to the study visit schedule and other protocol requirements (including prolonged fasting). Exclusion Criteria: Prior RT for any malignancy leading to overlap with planned RT fields. Prior chemotherapy for any malignancy. Subjects suffering from severe claustrophobia. Subjects who have had a research study involving radiation within one year of enrolling in this study Subjects who are pregnant (subjects 18 to 60 years old who are able to become pregnant unless documented hysterectomy or bilateral ovarian removal is available will be tested prior to injection of imaging agent - positive test will exclude from participating in the study) Subjects who are breastfeeding Prisoners. Any significant medical condition that in the opinion of the investigator would prevent the subject from participating and/or adhering to study related procedures or interfere with subject safety (e.g., poorly controlled diabetes). Children (<18 years of age). Body weight more than 240 kg (529 pounds) -

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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Total-body PET scan<br>All participants are asked to complete two study scan visits. First visit occurs before treatment and the second visit occurs 12 +/- 2 weeks after treatment. Each visit will involve a single injection of FDG, followed by three PET/CT scans that will start immediately following injection, at about 2 hours post-injection and at 5 hours post-injection, respectively and last about 60 minutes, 20 minutes and 20 minutes, respectively. | Diagnostic Test: Total Body PET/CT Imagin<br>* Total-body PET imaging at different timepoints<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Utility of long-delayed FDG PET Imaging | The retention index based on the SUVmax for Oral Cancer and Radiotherapy-induced inflammation | Percent change from baseline to 2 hour post injection |