Total-Body PET Scan for Head and Neck Cancer

Overseen By Dana Little

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Prior RT, Chemotherapy, Claustrophobia, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

7 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Who Is on the Research Team?

Tokihiro Yamamoto, PhD

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Stage II-IVa head and neck cancer who are set to receive radiation therapy. Participants must be able to lie still for up to an hour, give informed consent, follow the study schedule, and fast as required. It's not for those who've had prior radiation or chemo that overlaps with this treatment area, have severe claustrophobia, are pregnant or breastfeeding, prisoners, children under 18, weigh over 240 kg, or have a medical condition that could affect their safety in the study.

Inclusion Criteria

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

My ovarian cancer is between stage II and IVa and I am planned for radiation therapy of at least 60 Gy.

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

Exclusion Criteria

Subjects suffering from severe claustrophobia.

Prisoners.

I've had radiation therapy before in areas where I might get it again.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment PET Scan

Participants undergo a total-body PET/CT scan before treatment, involving FDG injection and three scans at different time points post-injection

1 day

1 visit (in-person)

Post-Treatment PET Scan

Participants undergo a total-body PET/CT scan 12 +/- 2 weeks after treatment, involving FDG injection and three scans at different time points post-injection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Total Body PET/CT Imaging

Trial Overview The trial is testing how a radioactive sugar (FDG) used in PET/CT scans behaves in patients immediately after injection and hours later using the EXPLORER total-body scanner. The aim is to improve response assessment of radiotherapy in head and neck cancers.

How Is the Trial Designed?

Group I: Total-body PET scan Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Colorado SPORE Developmental Research Program

Collaborator

Trials

1

Recruited

7+