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Ultralow Dose PET Imaging of SSTR2 Radiotracer Uptake

RECRUITINGPhase 2Sponsored by Akiva Mintz
Actively Recruiting
PhasePhase 2
SponsorAkiva Mintz
Started2025-12-11
Est. completion2030-04-30
Eligibility
Age18 Years – 120 Years
Healthy vol.Accepted
Locations1 site

Summary

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

Eligibility

Age: 18 Years – 120 YearsHealthy volunteers accepted
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.

Conditions4

CancerHealthy (Controls)Healthy VolunteersNeuroendocrine (NE) Tumors

Locations1 site

Nuclear Imaging Institute
Englewood, New Jersey, 07631
Barbara Blanchfield9732554955bblanchfield@nii.org

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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