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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of using PET scans to spot and track cancer. The aim is to determine if a much lower dose of radiation can be used, making it safer for participants. Participants will receive an injection of a special tracer, 18F-FDG (a radioactive glucose compound), and undergo imaging to evaluate the effectiveness of this new method. Suitable candidates have cancer and can remain in a scanner for up to three hours. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to innovative cancer detection methods.

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 prior data suggests that this ultralow dose PET imaging technique is safe for cancer detection?

Research has shown that ultralow dose 18F-FDG PET imaging is safe for humans. Some studies have even used it for cancer checks in pregnant women due to its low radiation levels. This method is generally well-tolerated and reduces risks. The radiation in this imaging is much lower than in standard procedures, making it a safer choice for many patients. Evidence indicates that it accurately detects cancer while keeping radiation exposure low. So far, these studies have reported no major side effects, supporting its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ultralow dose 18F-FDG imaging for cancer because it offers a way to reduce radiation exposure during PET scans, which are commonly used to detect and monitor cancer. Unlike standard PET scans that use higher doses of radioactive tracers, this method uses a minimal amount of 18F-FDG, making it safer for patients, especially those requiring repeated imaging. Additionally, maintaining image quality with a lower dose could revolutionize cancer imaging by providing critical information while minimizing potential risks associated with radiation.

What evidence suggests that this ultralow dose PET imaging technique is effective for cancer detection and monitoring?

Research has shown that 18F-FDG PET imaging excels at detecting and monitoring cancer. Studies have found it more accurate than other methods, particularly in determining cancer stages or checking for recurrence, aiding doctors in choosing the best care for patients. In this trial, participants will join the Ultralow Dose 18F-FDG Imaging Group, which employs a new method that significantly reduces radioactive material, enhancing safety. One study found that radiation could be reduced by 90% without losing important image details. This advancement makes imaging safer for patients while still providing doctors with a clear understanding of the cancer. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3101722/

18F-FDG PET/CT Imaging In Oncology - PMC - PubMed Central

18 F-FDG PET/CT is more sensitive and specific in certain cancers and has been applied primarily as a staging and restaging tool that can guide patient care.

2.

frontiersin.org

frontiersin.org/journals/physics/articles/10.3389/fphy.2024.1378521/full

Low-dose and standard-dose whole-body [18F]FDG-PET/ ...

The study demonstrated that a reduction of 90% in the administered [18F]FDG activity is feasible for semi-quantitative whole-body PET/CT imaging ...

3.

jnm.snmjournals.org

jnm.snmjournals.org/content/jnumed/early/2025/04/10/jnumed.124.268380.full.pdf

Feasibility of an Ultra-Low-Dose PET Scan Protocol with ...

This retrospective analysis includes data from 4 healthy subjects who received ultra-low-dose 18F-FDG PET/CT scans with a Biograph. Vision ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S095980492101131X

Impact of 18F-Fluorodeoxyglucose positron emission ...

FDG-PET or FDG-PET/CT had a meaningful impact on the management of patients with cancer of unknown primary origin. Approximately a third of the patients had ...

5.

tcr.amegroups.org

tcr.amegroups.org/article/view/11984/html

Extremely low dose 18F-FDG PET imaging and its potential ...

In thoracic oncology, 18F-FDG PET currently plays a major role in clinical diagnosis, staging, prognosis and assessment of response to treatment (6).

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40464157/

The 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 ...

7.

journals.lww.com

journals.lww.com/nuclearmedicinecomm/fulltext/2025/08000/the_safety_and_clinical_impact_of_ultra_low_dose.14.aspx

The safety and clinical impact of ultra-low-dose FDG-PET...

Ultra-low-dose FDG-PET imaging is a valuable tool providing accurate staging information to guide treatment decisions.

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06956391

Ultralow Dose PET Imaging of 18F-FDG Uptake

Investigators will enroll individuals with and without cancer to evaluate how ultralow dose PET imaging detects 18F-FDG uptake in different types of tissue.

9.

jnm.snmjournals.org

jnm.snmjournals.org/content/56/6/955

Summary of the UPICT Protocol for 18F-FDG PET/CT Imaging ...

The FDG PET/CT Profile is a document that includes a claim on the measurement performance of FDG PET/CT imaging if certain conditions are met.

10.

ejnmmiphys.springeropen.com

ejnmmiphys.springeropen.com/articles/10.1186/s40658-024-00648-w

Ultra-low foetal radiation exposure in 18F-FDG PET/CT ...

The ultra-low administrated radioactivity led to a maximum foetal radiation exposure from the PET of 0.44 mGy. In our study, the estimated ...