Ultralow Dose PET Imaging of SSTR2 Radiotracer Uptake
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 68Ga-Dotatate.
- Who it may be relevant to
- Registry conditions: Healthy (Controls), Healthy Volunteers, Neuroendocrine (NE) Tumors. Basic parameters: 18 years — 120 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Ultralow Dose PET Imaging for Detecting SSTR2 Radiotracer Uptake
Overview
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.
Interventions
- Drug 68Ga-Dotatate
Participants will be injected with 68Ga-DOTATATE and imaged for up to 3 hours on a PET scanner
Primary outcome measures
- Signal-to-Noise Ratio (SNR) [Time frame: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.]
- Contrast-to-Noise Ratio (CNR) [Time frame: Time Frame: 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.]
- 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.]
- Target-to-Background Ratio (TBR) [Time frame: 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.]
- Inter-reader Agreement (Weighted Kappa Statistics) [Time frame: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Nuclear Imaging Institute — Englewood
Identifiers
NCT: NCT07284589 · NII-0008-SSTR