NCT07284589

Ultralow Dose PET Imaging of SSTR2 Radiotracer Uptake

Evaluation of Ultralow Dose PET Imaging for Detecting SSTR2 Radiotracer Uptake

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Akiva Mintz · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to evaluate an investigational ultralow dose positron emission tomography (PET) imaging technique for neuroendocrine tumor 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 that binds to a tumor specific protein called somatostatin receptor 2 (SSTR2) and be imaged on a new type of high sensitivity PET scanner for up to 3 hours

Detailed description

This research study aims to evaluate an investigational ultralow dose PET imaging technique for neuroendocrine tumor detection and monitoring. "Investigational" means that the procedure or drug being studied is not yet approved by the U.S. Food and Drug Administration (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, Gallium-68 (68Ga)-Dotatate, is FDA-approved for detecting neuroendocrine cancer at standard doses. 68Ga-Dotatate is often found to be taken up at higher levels in in neuroendocrine tumors. 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 treatment response. Investigators will enroll individuals with and without neuroendocrine tumors to evaluate how ultralow dose PET imaging detects radiotracer uptake in different type of tissue. Approximately 200 people will be enrolled in this study at the Nuclear Imaging Institute.

Conditions

• Healthy (Controls)
• Healthy Volunteers
• Neuroendocrine (NE) Tumors

Interventions

Type	Name	Description
DRUG	68Ga-Dotatate	Participants will be injected with 68Ga-DOTATATE and imaged for up to 3 hours on a PET scanner

Timeline

• Start date: 2025-12-11
• Primary completion: 2030-04-30
• Completion: 2030-04-30
• First posted: 2025-12-16
• Last updated: 2026-04-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study