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OpenTrials
Completed

NCT Number: NCT05625217

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis EXPLORER Molecular Imaging Center

Sacramento, California, 95816, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

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Treatment and study plan

Total Body PET/CT Imagin

Diagnostic Test

Total-body PET imaging at different timepoints

Primary outcomes

  1. Utility of long-delayed FDG PET Imaging

    Time frame: Percent change from baseline to 2 hour post injection

    The retention index based on the SUVmax for Oral Cancer and Radiotherapy-induced inflammation

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 22, 2022
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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