Actively Recruiting

Phase 2
Age: 18Years - 120Years
All Genders
Healthy Volunteers
ID07284589

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

Age: 18Years - 120Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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)

Long-term Monitoring

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

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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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