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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05625217
• Other study ID #: 1946919
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 27, 2023
• Est. completion date: November 2024

Study information

• Verified date: August 2023
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: November 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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) -

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Diagnostic Test:
• Total Body PET/CT Imagin
Total-body PET imaging at different timepoints

Locations

Country	Name	City	State
United States	UC Davis EXPLORER Molecular Imaging Center	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	Colorado SPORE Developmental Research Program

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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