Total-Body PET Scan for Head and Neck Cancer

LP
DL
Overseen ByDana Little
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Davis
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand the behavior of a radioactive sugar, called FDG, in people with head and neck cancer using a new whole-body scanner (Total Body PET/CT Imaging). Participants will undergo two sets of scans: one before starting their cancer treatment and another about 12 weeks after. This trial suits individuals with stage II-IVa head and neck cancer who can remain still for up to an hour during the scans. As an unphased trial, it offers a unique opportunity to contribute to innovative imaging research that could enhance future cancer diagnostics.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this total-body PET/CT imaging is safe for head and neck cancer patients?

Research has shown that total-body PET/CT scans are safe and generally well-tolerated. These scans use a very small amount of radioactive material, which keeps the risk low. Current evidence suggests that PET/CT scans are low-risk procedures commonly used in medical settings for diagnosis.

The use of FDG, a type of radioactive sugar, in these scans is standard and has been shown to be very safe. Although there is some exposure to a small amount of radiation, the risks are considered minimal.

Overall, total-body PET/CT imaging is viewed as a safe option for patients, with few reports of side effects.12345

Why are researchers excited about this trial?

Researchers are excited about total-body PET/CT imaging for head and neck cancer because it offers a comprehensive view of the entire body, potentially improving the detection of cancer spread compared to standard imaging techniques. Unlike traditional scans that focus on specific areas, this method captures detailed images of the whole body at multiple time points, allowing for better monitoring of how the cancer responds to treatment. This could lead to more personalized and effective treatment plans, ultimately enhancing patient outcomes.

What evidence suggests that total-body PET/CT imaging is effective for head and neck cancer?

Research has shown that a special type of scan called PET/CT, which uses a substance known as FDG, detects head and neck cancer more effectively than regular CT scans. Studies indicate that PET scans can detect cancer 87% of the time, compared to 62% for CT scans, making PET scans more effective at spotting cancer. In this trial, participants will undergo a total-body PET/CT scan, which reduces radiation exposure while still providing clear images. Overall, PET/CT is a powerful tool for detecting cancer and aiding doctors in planning effective treatments.678910

Who Is on the Research Team?

TY

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).
See 1 more

Exclusion Criteria

Subjects suffering from severe claustrophobia.
Prisoners.
I've had radiation therapy before in areas where I might get it again.
See 7 more

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?
1Treatment groups
Experimental Treatment
Group I: Total-body PET scanExperimental Treatment1 Intervention

Find a Clinic Near You

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+

Citations

Clinical Applications of FDG PET and PET/CT in Head and ...A literature survey on the use of 18F-FDG PET in head and neck cancer (HNC) compared to CT indicates that PET has a higher sensitivity (87% versus 62%) and ...
Total-Body PET/CT: Challenges and OpportunitiesThis review aims to identify possible challenges and opportunities for PET-centers working with TB and LAFOV systems.
Advantages and Challenges of Total-Body PET/CT at a ...Preliminary results suggest that the total effective dose of a total-body PET/CT scan can be reduced to a minimum of 3.75 mSv.
Positive and Negative Predictive Value of PET-CT in Skull ...Of the 20 “positive” PET-CT results, there were only 4 false positives based on correlation with tissue histopathology. The reading radiologist interpretation ...
PET/CT for Head and Neck Squamous Cell CarcinomaThe purpose of our study was to determine the diagnostic and therapeutic yield of the head and abdomen portions of PET/CT scans of patients with head and neck ...
Total-body PET/CT – first clinical experiences and future ...The capability of total-body PET scanners to provide diagnostic quality images with small amounts of activity in the field of view also opens new possibilities ...
PET/CT - Positron Emission Tomography/Computed ...Current and accurate information for patients about PET/CT. Learn what you might experience, how to prepare for the exam, benefits, risks and much more.
Role of 18F-FDG PET-CT in head and neck squamous cell ...In particular, 18F-FDG PET-CT has a high negative predictive value (> 95%) that can spare the patient of unnecessary diagnostic invasive procedures and neck ...
Total Body PET/CT: Future AspectsThis review explores the future of LAFOV technology based on recent literature and experiences, covering its clinical applications, implications for radiation ...
FDG-PET/CT in Assessing the Tumor and Planning Neck ...PURPOSE: This phase II trial is studying fludeoxyglucose F 18-PET/CT imaging to see how well it works in assessing the tumor and planning neck surgery in ...
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