Ultralow Dose PET Imaging of SSTR2 Radiotracer Uptake
Purpose
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
Conditions
- Healthy (Controls)
- Healthy Volunteers
- Neuroendocrine (NE) Tumors
Eligibility
- Eligible Ages
- Between 18 Years and 120 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Age ≥18 years. - Ability to provide informed consent and comply with study procedures. - For female participants: Must not be pregnant or breastfeeding; Negative pregnancy test required for women of childbearing potential.
Exclusion Criteria
- Participants who have exceeded NRC regulation for annual radiation exposure from prior research-related scans, including this study (50 millisievert [mSv] total). - More than four prior enrollments in this study. - Participants with severe claustrophobia, chronic pain, or musculoskeletal conditions that prevent completion of the PET scan - Medication & Prior Treatment Exclusions: SSTR targeted therapies - Pregnant or breastfeeding individuals (negative pregnancy test required) - Inability to provide informed consent - Any condition that, in the investigator's judgment, may compromise participant safety or study integrity.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- This is a prospective, open-label, single-center imaging study designed to evaluate the optimal timing and reconstruction parameters for ultralow dose PET imaging using a long axial field-of-view (LAFOV) PET scanner. The study aims to determine whether normal and diseased tissue can be accurately visualized at significantly lower radiotracer doses, while optimizing scan duration and reconstruction methods to maintain diagnostic performance. A total of 200 participants will be enrolled in a single cohort, including healthy volunteers and individuals with suspected or confirmed neuroendocrine tumors. The inclusion of both healthy and diseased subjects allows for a comprehensive evaluation of normal organ uptake patterns, which is the primary objective of the study. Participants will undergo a single PET scan session per an enrollment, and be eligible for re-enrollment after 6 months, for a maximum of 5 enrollments if they meet criteria.
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Other Ultralow dose 68Ga-DOTATATE imaging group |
Participants will be enrolled for an ultralow dose PET scan to evaluate image quality and optimize timing and reconstruction after reducing radiation doses 10-100 fold. Participants will be injected with a very small amount of radiotracer and imaged on a PET scanner for up to 3 hours |
|
Recruiting Locations
Englewood 5097672, New Jersey 5101760 07631
More Details
- Status
- Recruiting
- Sponsor
- Akiva Mintz
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.