Ultralow-dose PET imaging of somatostatin receptor 2 (SSTR2) uptake
Evaluation of Ultralow Dose PET Imaging for Detecting SSTR2 Radiotracer Uptake
This study will test whether an ultralow-dose 68Ga-Dotatate PET scan on a high-sensitivity scanner can detect SSTR2 uptake in adults with and without neuroendocrine tumors.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | Nuclear Imaging Institute Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Englewood, New Jersey) |
| Trial ID | NCT07284589 on ClinicalTrials.gov |
What this trial studies
Participants will receive a very small amount of the FDA-approved radiotracer 68Ga-Dotatate (less than about 1/20th of the standard dose) and be imaged on a new high-sensitivity PET scanner for up to three hours. Investigators will vary injection-to-scan timing, scan duration, and image reconstruction methods to determine how low the radiation dose can be reduced while preserving image quality. The study will enroll roughly 200 adults, including healthy volunteers and people with neuroendocrine tumors, and will compare tracer uptake patterns across groups. Outcomes will focus on image quality and ability to detect SSTR2-expressing lesions at ultralow doses.
Who should consider this trial
Good fit: Adults aged 18 or older who can give informed consent, are not pregnant or breastfeeding, and either have a known or suspected neuroendocrine tumor or are healthy volunteers willing to undergo PET imaging and follow study rules are ideal candidates.
Not a fit: People who are pregnant or breastfeeding, unable to tolerate a prolonged scan (severe claustrophobia or mobility limits), those who have exceeded annual research radiation limits, or those currently on SSTR-targeted therapies are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this technique could allow much lower-radiation PET scans that enable safer and more frequent imaging for detection and treatment monitoring of neuroendocrine tumors.
How similar studies have performed: Standard-dose 68Ga-Dotatate PET is well established for neuroendocrine tumors, and small pilot studies using high-sensitivity scanners and reduced tracer doses have shown promise, but ultralow-dose reductions of 10–100x remain largely unproven in large cohorts.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Englewood, New Jersey
- Nuclear Imaging Institute — Englewood, New Jersey, United States (Recruiting)
Study contacts
- Study coordinator: Barbara Blanchfield
- Email: bblanchfield@nii.org
- Phone: 9732554955
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.