RecruitingPhase 2

Ultralow Dose PET Imaging of SSTR2 Radiotracer Uptake

United States200 participantsStarted 2025-12-11

Plain-language 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

Who can participate

Age range

18 Years – 120 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Signal-to-Noise Ratio (SNR)

Timeframe: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.

Contrast-to-Noise Ratio (CNR)

Timeframe: Time Frame: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.

Coefficient of Variation (COV)

Timeframe: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.

Spatial Resolution (Full Width at Half Maximum - FWHM)

Timeframe: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.

Target-to-Background Ratio (TBR)

Timeframe: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.

Qualitative Image Quality Score (Likert Scale)

Timeframe: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.

Trial details

NCT IDNCT07284589

SponsorAkiva Mintz

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-04-30

Contact for this trial

Barbara Blanchfield

9732554955 bblanchfield@nii.org

View on ClinicalTrials.gov More Healthy (Controls) trials

Plain-language summary

Who can participate

Age range

18 Years – 120 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Signal-to-Noise Ratio (SNR)

Timeframe: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.

Contrast-to-Noise Ratio (CNR)

Timeframe: Time Frame: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.

Coefficient of Variation (COV)

Timeframe: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.

Spatial Resolution (Full Width at Half Maximum - FWHM)

Timeframe: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.

Target-to-Background Ratio (TBR)

Timeframe: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.

Qualitative Image Quality Score (Likert Scale)

Timeframe: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.