Oral FDG Scans for Cancer
(HELP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method for performing PET scans to detect cancer by having participants drink a liquid with a special tracer instead of receiving it through an IV. By comparing this oral method (Oral FDG scan) to the traditional IV method, researchers aim to determine the optimal time to scan after drinking the tracer and assess patient preference. The trial seeks participants who have already undergone a standard PET scan and are willing to try this new method within two weeks. As an unphased trial, it offers participants the chance to contribute to innovative research that could make PET scans more comfortable and accessible.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking biguanide anti-hyperglycemic agents (like Metformin) or if you are an insulin-dependent diabetic.
What prior data suggests that this method is safe for oral FDG scans?
Research shows that 18F-FDG, commonly used in PET scans, safely detects cancer in the body. Many studies have examined its effectiveness and safety. One study found that using 18F-FDG in PET scans carries low risks and remains safe even for pregnant women due to the low radiation dose.
Another study discovered that using 18F-FDG in PET scans is effective and safe for regular check-ups after cancer treatment, reassuring doctors of the scans' reliability and safety.
The current trial explores a new method where patients drink 18F-FDG instead of receiving it through an injection. While specific safety data for this new approach is not yet available, existing studies on 18F-FDG suggest it is generally well-tolerated.12345Why are researchers excited about this trial?
Researchers are excited about the Oral FDG scan because it offers a new, less invasive way to perform cancer imaging. Unlike the standard FDG scans that require an intravenous (IV) injection of the tracer, this method allows patients to simply drink the FDG diluted in water. This could make the process more comfortable and safer for patients, potentially reducing the risk of complications associated with IV administration. Additionally, if successful, this approach might streamline the imaging process and increase accessibility for patients needing these crucial diagnostic tests.
What evidence suggests that this method is effective for cancer detection?
Research has shown that 18F-FDG PET scans excel at detecting and staging various cancers, including those in the mouth. Studies indicate that these scans can accurately measure tumor size and help identify the cancer stage. For patients with mouth cancer, 18F-FDG PET/CT scans have precisely staged tumors, even when traditional imaging methods encounter difficulties. In this trial, participants will receive both the standard FDG scan, with the tracer injected through an IV, and an experimental Oral FDG scan, where the tracer is taken by mouth. The study tests whether the oral method can provide similar results while offering more comfort for patients.56789
Are You a Good Fit for This Trial?
This trial is for individuals who may have cancer and are undergoing PET scans. It's a small study looking to include 15-24 participants. Specific eligibility criteria aren't provided, but typically, patients must be in stable health and able to comply with the study requirements.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive one standard of care FDG scan and one oral FDG scan within 14 days of each other
Protocol Optimization
Study divided into 3 steps to test different uptake times and patient activity levels
Follow-up
Participants are monitored for image quality and participant preference after scans
What Are the Treatments Tested in This Trial?
Interventions
- Oral FDG scan
Trial Overview
The HELP Study is testing if swallowing a radioactive sugar (18F-FDG) can replace IV injections for PET scans. Participants will get two PET scans: one with the usual IV method and another after drinking the solution, to see when it's best to scan them.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will receive their standard of care FDG scan and then an Oral FDG scan within two weeks. The standard of care FDG scan will involve IV administration of FDG. The Oral FDG scan will involve FDG diluted in 50ml (approx.) of water to be consumed by mouth. The length of the oral FDG scans and its comparison to the standard FDG scan depends on which step the study is currently on. Please refer to the Study Design for details on the Oral FDG scan.
Find a Clinic Near You
Who Is Running the Clinical Trial?
British Columbia Cancer Agency
Lead Sponsor
Citations
Role of the FDG PET CT Scan in Pretreatment Evaluation of ...
The FDG PET CT scan is a highly effective tool for accurately diagnosing, staging, and predicting the outcome of oral cancers at all stages of ...
Clinical values of 18F‐FDG PET/CT in oral cavity cancer ...
Conclusion: 18F-FDG PET/CT scans provide accurate tumor staging and volume measurements in OSCC patients with CR/MRI dental artifacts, leading ...
18F-FDG PET as a Routine Posttreatment Surveillance Tool in ...
For the 3- and 6-mo posttherapy results combined, 18F-FDG PET detected malignancy in 16 of the 18 patients. Conclusion: 18F-FDG PET is a suitable routine ...
Impact of 18F-Fluorodeoxyglucose positron emission ...
In 38 studies with cancer of unknown primary, 18F-fluoro-2-deoxyglucose positron emission tomography changed management 35%.c. •. These were related to find the ...
Post-treatment FDG PET-CT in head and neck carcinoma
All IC were accurate for prediction of primary tumour (mean NPV 85.0% (84.6–85.3), PPV 85.0% (82.5–92.3), accuracy 84.9% (84.2–86.0)) and nodal ...
Efficacy and safety of FDG-PET for determining target ...
To determine the efficacy and safety of target volume determination by 18 F-fluorodeoxyglucose positron emission tomography-computed tomography (PET-CT)
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journals.lww.com
journals.lww.com/nuclearmedicinecomm/fulltext/2025/08000/the_safety_and_clinical_impact_of_ultra_low_dose.14.aspxThe safety and clinical impact of ultra-low-dose FDG-PET...
The low radiation dose associated with this technique makes it a clinically acceptable modality for cancer staging in pregnant women. A larger case series is ...
Accuracy of 18-F Fluorodeoxyglucose Positron Emission ...
Findings This diagnostic study including 135 patients showed 83.3% sensitivity, 84.8% specificity, and a negative predictive value of 93.3% with ...
Efficacy and safety of FDG-PET for determining target ...
The results suggest that the target volume determined by PET-CT could safely reduce GTV size and interobserver variability in patients with locally advanced ...
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