Actively Recruiting
Evaluation of Ultralow Dose PET Imaging for Detecting SSTR2 Radiotracer Uptake
Led by Akiva Mintz · Updated on 2026-04-08
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an investigational ultralow dose positron emission tomography (PET) imaging technique to detect and monitor neuroendocrine tumors. The study aims to determine if the timing, scan duration, and image reconstruction can be optimized to reduce radiation exposure by 10 to 100 times compared to the current clinical standard. The imaging uses a radioactive tracer that binds to somatostatin receptor 2 (SSTR2), a protein found on these tumors, to help visualize them more safely. Participants will receive an injection of a very small amount of the radiotracer Gallium-68 (68Ga)-Dotatate, which is approved for detecting neuroendocrine cancer at standard doses. They will then undergo scanning on a high sensitivity PET scanner for up to three hours. The study includes people with and without neuroendocrine tumors to evaluate how well the ultralow dose technique detects tracer uptake in different tissues. During the study, participants will be monitored annually through image evaluations using measures like signal-to-noise ratio, contrast-to-noise ratio, and qualitative image quality scores. Researchers will review images collected over the year to assess how well the low dose imaging performs. The total involvement may last several years since these image evaluations happen once per year, and the trial is planned to continue until 2030. Safety and image quality are key outcomes throughout the study.
CONDITIONS
Brief Title
Ultralow Dose PET Imaging of SSTR2 Radiotracer Uptake
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Ability to provide informed consent and comply with study procedures
- For female participants: Not pregnant or breastfeeding; negative pregnancy test required if of childbearing potential
You will not qualify if you...
- Radiation exposure from prior research scans exceeding 50 millisievert total per year
- More than four prior enrollments in this study
- Severe claustrophobia, chronic pain, or musculoskeletal conditions preventing PET scan completion
- Use of somatostatin receptor targeted therapies
- Pregnant or breastfeeding individuals
- Inability to provide informed consent
- Any condition that may compromise safety or study integrity according to the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 hours
Participants receive an injection of a very small amount of 68Ga-DOTATATE radiotracer and undergo PET imaging to evaluate image quality and optimize timing and reconstruction at ultralow radiation doses.
1 visit (in-person)
Duration - Up to 7 years
Participants’ imaging results are evaluated annually to assess image quality and radiotracer uptake using pooled images acquired over the preceding 12-month period.
Annual follow-up visits
Trial Site Locations
Total: 1 location
1
Nuclear Imaging Institute
Englewood, New Jersey, United States, 07631
Actively Recruiting
Research Team
B
Barbara Blanchfield
D
Dianna Willis, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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