Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultralow dose 68Ga-DOTATATE imaging group | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-Dotatate | Drug | Participants will be injected with 68Ga-DOTATATE and imaged for up to 3 hours on a PET scanner |
|
| Measure | Description | Time Frame |
|---|---|---|
| Signal-to-Noise Ratio (SNR) | Measurement of signal-to-noise ratio for image quality assessment across different scan durations, reconstruction techniques, and artificial intelligence (AI)-enhanced image reconstructions. Unit of Measure: SNR (unitless, numeric ratio) | Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period. |
| Contrast-to-Noise Ratio (CNR) | Measurement of contrast-to-noise ratio for image quality assessment across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions. Unit of Measure: CNR (unitless, numeric ratio) | Time Frame: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period. |
| Coefficient of Variation (COV) | Measurement of the coefficient of variation in selected regions for evaluating image consistency across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions. Unit of Measure: Percentage (%) | Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period. |
| Spatial Resolution (Full Width at Half Maximum - FWHM) | Assessment of spatial resolution using full width at half maximum (FWHM) across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions. Unit of Measure: Millimeters (mm) | Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period. |
| Target-to-Background Ratio (TBR) | Assessment of target-to-background ratio for evaluating SSTR2-expressing tissue contrast across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions. Unit of Measure: Ratio (unitless numeric ratio) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Barbara Blanchfield | Contact | 9732554955 | bblanchfield@nii.org | |
| Dianna Willis, PhD | Contact | 973-513-7832 | dewillis@nii.org |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nuclear Imaging Institute | Recruiting | Englewood | New Jersey | 07631 | United States |
IDP sharing status is currently undecided pending internal review.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C513399 | gallium Ga 68 dotatate |
| D009682 | Magnetic Resonance Spectroscopy |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D013048 | Specimen Handling |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period. |
| Qualitative Image Quality Score (Likert Scale) | Independent qualitative evaluation of overall image quality, lesion detectability, image noise, and artifacts by nuclear medicine physicians, assessed using a 5-point Likert scale. Unit of Measure: Score on Likert Scale (1-5; 1 = worst, 5 = best) | Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period. |
| Inter-reader Agreement (Weighted Kappa Statistics) | Measurement of agreement among readers evaluating qualitative image quality scores, analyzed using weighted kappa statistics. Unit of Measure: Weighted kappa statistic (numeric value ranging from 0 to 1, 0 = no agreement, 1 = perfect agreement) | Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period. |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |