Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 120

Ultralow-dose PET imaging of somatostatin receptor 2 (SSTR2) uptake

Official title: Evaluation of Ultralow Dose PET Imaging for Detecting SSTR2 Radiotracer Uptake

Run by Nuclear Imaging Institute · NCT07284589 · Data updated 2026-11-12

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.

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Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 120 Years
SexAll
Enrollment200 (estimated)
SponsorNuclear Imaging Institute
Academic / other
Drugs / interventionsradiation
Locations1 site (Englewood, New Jersey)
StatusRecruiting
StartedDecember 11, 2025
Main results expectedApril 30, 2030
Study endsApril 30, 2030
Registry record updatedApril 8, 2026
Trial IDNCT07284589 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Nuclear Imaging Institute
    Englewood, New Jersey, United States
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.