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

NCT ID: NCT05625217

Last Updated: 2025-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-27
• Study Completion Date: 2024-11-20

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Total-body PET scan

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.

Group Type: EXPERIMENTAL

Total Body PET/CT Imagin

Intervention Type: DIAGNOSTIC_TEST

Total-body PET imaging at different timepoints

Interventions

Total Body PET/CT Imagin

Total-body PET imaging at different timepoints

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Stage II-IVa (American Joint Committee on Cancer, 8th edition) OC who are planned for RT (≥60 Gy) as per routine clinical standard.

2. Patient must be ≥18 years of age.

3. Willing and able to lay motionless in a supine position for up to 60 minutes

4. Patient must be able to provide study specific informed consent prior to study entry.

5. Patient must be able to adhere to the study visit schedule and other protocol requirements (including prolonged fasting).

Exclusion Criteria

1. Prior RT for any malignancy leading to overlap with planned RT fields.

2. Prior chemotherapy for any malignancy.

3. Subjects suffering from severe claustrophobia.

4. Subjects who have had a research study involving radiation within one year of enrolling in this study

5. 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)

6. Subjects who are breastfeeding

7. Prisoners.

8. 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).

9. Children (<18 years of age).

10. Body weight more than 240 kg (529 pounds)

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tokihiro Yamamoto, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

UC Davis EXPLORER Molecular Imaging Center

Sacramento, California, United States

Countries

United States

Other Identifiers

1946919

Identifier Type: -

Identifier Source: org_study_id