Ultralow Dose PET Imaging for Cancer

Overseen By Barbara Blanchfield

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Akiva Mintz

Disqualifiers: Radiation exposure, Claustrophobia, Chronic pain, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

200 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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 to get a clear answer.

What data supports the effectiveness of the treatment 18F-FDG in ultralow dose PET imaging for cancer?

Research shows that ultralow-dose 18F-FDG PET/CT imaging can still provide good image quality and detect cancer lesions effectively, similar to higher doses. This technology is already used in various medical fields to differentiate between benign and malignant lesions, monitor therapy, and guide treatment decisions. ^{1 2 3 4 5}

Is ultralow dose 18F-FDG PET imaging safe for humans?

Studies have shown that ultralow dose 18F-FDG PET imaging is feasible and involves lower radiation exposure compared to standard doses, which suggests it is generally safe for humans. However, as with any procedure involving radiation, there are risks, and these should be weighed against the benefits, especially in sensitive populations like pregnant women. ^{1 4 6 7 8}

How is the drug 18F-FDG used in ultralow dose PET imaging for cancer different from other treatments?

The drug 18F-FDG is used in ultralow dose PET imaging, which allows for high-quality cancer detection images with significantly less radiation exposure compared to standard doses. This approach is unique because it maintains image quality while reducing the potential risks associated with higher radiation levels. ^{1 4 5 9 10}

What is the purpose of this trial?

The goal of this clinical trial is to evaluate an investigational ultralow dose PET imaging technique for cancer detection and monitoring. The main question it aims to answer is: Can the investigators optimize the timing, scan duration, and image reconstruction to reduce the radiation dose 10-100 fold of the current clinical standard? Participants will be injected with a radioactive tracer called 18F-FDG and be imaged on a new type of high-sensitivity PET scanner for up to 3 hours.

Eligibility Criteria

This trial is for healthy individuals and cancer patients interested in a new PET scan technique that uses much less radiation. Specific eligibility criteria are not provided, so participants should inquire with the study team to determine if they qualify.

Inclusion Criteria

Ability to provide informed consent and comply with study procedures

I am a woman who can have children and have a negative pregnancy test.

I am not pregnant or breastfeeding.

Exclusion Criteria

Participants who have exceeded NRC regulation for annual radiation exposure from prior research-related scans, including this study (50 mSv total)

More than four prior enrollments in this study

Pregnant or breastfeeding individuals (negative pregnancy test required)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants are injected with a radioactive tracer called 18F-FDG and imaged on a high-sensitivity PET scanner for up to 3 hours

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

12 months

Annual evaluation based on pooled images

Treatment Details

Interventions

• 18F-FDG

Trial Overview The trial tests an ultralow dose PET imaging method using a radioactive tracer called 18F-FDG. It aims to reduce radiation exposure by optimizing timing, scan duration, and image processing on a high-sensitivity scanner.

Participant Groups

Group I: Ultralow Dose 18F-FDG Imaging Group Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Akiva Mintz

Lead Sponsor

Trials

1

Recruited

40+

Findings from Research

The average radiation exposure from FDG-PET scans is estimated at 4.4 mSv for dedicated PET and 13.5 mSv for PET/CT, which is higher than typical X-ray tests, indicating a need for careful consideration of risks.

The study found that FDG-PET cancer screening is beneficial for individuals above certain break-even ages: in the 40s for men and 30s for women for dedicated PET, and in the 50s for both genders for PET/CT, suggesting that the benefits of screening outweigh the risks of radiation exposure in these age groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation exposure and risk-benefit analysis in cancer screening using FDG-PET: results of a Japanese nationwide survey. Murano, T., Minamimoto, R., Senda, M., et al.[2016]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Ultralow-dose [18F]FDG PET/CT imaging: demonstration of feasibility in dynamic and static images. [2023]

2. Italy pubmed.ncbi.nlm.nih.gov

Significant dose reduction is feasible in FDG PET/CT protocols without compromising diagnostic quality. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Metabolic imaging with FDG: a primer. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

Investigating ultra-low-dose total-body [18F]-FDG PET/CT in colorectal cancer: initial experience. [2022]

5. Ireland pubmed.ncbi.nlm.nih.gov

Automated detection of lung cancer at ultralow dose PET/CT by deep neural networks - Initial results. [2019]

6. Japan pubmed.ncbi.nlm.nih.gov

Radiation exposure and risk-benefit analysis in cancer screening using FDG-PET: results of a Japanese nationwide survey. [2016]

7. Germany pubmed.ncbi.nlm.nih.gov

Radiation exposure and mortality risk from CT and PET imaging of patients with malignant lymphoma. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

18F-FDG PET in pregnancy and fetal radiation dose estimates. [2015]

9. Germany pubmed.ncbi.nlm.nih.gov

Image quality and lesion detectability in low-dose pediatric 18F-FDG scans using total-body PET/CT. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Feasibility of Acquisitions Using Total-Body PET/CT with an Ultra-Low 18F-FDG Activity. [2022]