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

NCT05625217 | Completed DMC

• 1 other identifier: 1946919
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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).

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Total-body PET scan

EXPERIMENTAL

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

Interventions

Total Body PET/CT Imagin DIAGNOSTIC_TEST

Total-body PET imaging at different timepoints

Total-body PET scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, Davis: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UC Davis EXPLORER Molecular Imaging Center

Sacramento, California, 95816, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Tokihiro Yamamoto, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 22, 2022
• Study Start: February 27, 2023
• Primary Completion: November 20, 2024
• Study Completion: November 20, 2024
• Last Updated: March 10, 2026

Record last verified: 2025-01

Locations

US (1)