Ultralow Dose PET Imaging of 18F-FDG Uptake

June 1, 2025 updated by: Akiva Mintz

Evaluation of Ultralow Dose PET Imaging for Detecting 18F-FDG Uptake

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This research study aims to evaluate an investigational ultralow dose PET imaging technique for cancer detection and monitoring. "Investigational" means that the procedure or drug being studied is not yet approved by the FDA for the specific use being tested in this research. The PET imaging technique used in this study is considered investigational because it is being tested at an ultralow radiation dose that has not yet been approved for clinical use. The radiotracer, 18F-FDG, is FDA-approved for detecting cancer at standard doses.

18F-FDG is often found to be taken up at higher levels in cancer. In this study, investigators will use a very small amount of this tracer (less than 1/20th of the standard dose) along with advanced PET imaging technology to see if it is possible to create clear images while using much less radiation. This study aims to develop a safer imaging technique that could potentially be used more frequently for screening and monitoring cancer.

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

Approximately 200 people will be enrolled in this study at the Nuclear Imaging Institute.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New Jersey
      • Englewood, New Jersey, United States, 07631
        • Recruiting
        • Nuclear Imaging Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Age ≥18 years.
  2. Ability to provide informed consent and comply with study procedures.

  3. For female participants:

    • Must not be pregnant or breastfeeding.
    • Negative pregnancy test required for women of childbearing potential.

Exclusion Criteria:

  1. Participants who have exceeded NRC regulation for annual radiation exposure from prior research-related scans, including this study (50 mSv total).
  2. More than four prior enrollments in this study.
  3. Participants with severe claustrophobia, chronic pain, or musculoskeletal conditions that prevent completion of the PET scan
  4. Medication & Prior Treatment Exclusions
  5. Pregnant or breastfeeding individuals (negative pregnancy test required)
  6. Inability to provide informed consent
  7. Any condition that, in the investigator's judgment, may compromise participant safety or study integrity.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultralow Dose 18F-FDG Imaging Group
Drug: 18F-FDG
Participants will be injected with 18F-FDG and imaged for up to 3 hours on a PET scanner
Other Names:
  • PET scan
  • CT scan
  • blood collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Signal-to-Noise Ratio (SNR)
Time Frame: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.
Measurement of signal-to-noise ratio for image quality assessment across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions. Unit of Measure: SNR (unitless, numeric ratio)
Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.
Contrast-to-Noise Ratio (CNR)
Time Frame: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.
Measurement of contrast-to-noise ratio for image quality assessment across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions. Unit of Measure: CNR (unitless, numeric ratio)
Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.
Coefficient of Variation (COV)
Time Frame: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.
Measurement of the coefficient of variation in selected regions for evaluating image consistency across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions. Unit of Measure: Percentage (%)
Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.
Spatial Resolution (Full Width at Half Maximum - FWHM)
Time Frame: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.
Assessment of spatial resolution using full width at half maximum (FWHM) across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions. Unit of Measure: Millimeters (mm)
Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.
Target-to-Background Ratio (TBR)
Time Frame: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.
Assessment of target-to-background ratio for evaluating PSMA-expressing tissue contrast across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions. Unit of Measure: Ratio (unitless numeric ratio)
Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.
Qualitative Image Quality Score (Likert Scale)
Time Frame: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.
Independent qualitative evaluation of overall image quality, lesion detectability, image noise, and artifacts by nuclear medicine physicians, assessed using a 5-point Likert scale. Unit of Measure: Score on Likert Scale (1-5; 1 = worst, 5 = best)
Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.
Inter-reader Agreement (Weighted Kappa Statistics)
Time Frame: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.
Measurement of agreement among readers evaluating qualitative image quality scores, analyzed using weighted kappa statistics. Unit of Measure: Weighted kappa statistic (numeric value ranging from 0 to 1, 0 = no agreement, 1 = perfect agreement)
Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akiva Mintz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2025

Primary Completion (Estimated)

June 30, 2030

Study Completion (Estimated)

June 30, 2030

Study Registration Dates

First Submitted

April 24, 2025

First Submitted That Met QC Criteria

April 24, 2025

First Posted (Actual)

May 4, 2025

Study Record Updates

Last Update Posted (Actual)

June 4, 2025

Last Update Submitted That Met QC Criteria

June 1, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NII-0002-FDG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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