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Ultralow Dose PET Imaging for Neuroendocrine Tumors

This study is testing a new way to use PET imaging to find and monitor neuroendocrine tumors. It uses a very small amount of a radioactive tracer called 68Ga-Dotatate, which attaches to a protein (SSTR2) often found on these tumors. The goal is to see if this "ultralow dose" imaging can create clear pictures while using 10 to 100 times less radiation than standard methods. This could make imaging safer and more frequent. Researchers will inject you with 68Ga-Dotatate and then image you on a special PET scanner for up to 3 hours. The study aims to enroll about 200 people, including healthy volunteers and those with neuroendocrine tumors, to see how well this technique works. The study status is currently unclear.

Study design
This is an interventional study planning to enroll 200 participants, including healthy controls and individuals with neuroendocrine tumors.
What's involved
Participants will be injected with 68Ga-Dotatate and then undergo PET imaging for up to 3 hours.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes will be evaluated annually based on pooled images acquired during the preceding 12-month period.

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NCT07284589

Ultralow Dose PET Imaging of SSTR2 Radiotracer Uptake

Recruiting
PHASE2Ages 18+InterventionalDiagnostic
Akiva Mintz
~200 participants
Updated 2026-04-08 on ClinicalTrials.gov
What's tested:68Ga-Dotatate

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Signal-to-Noise Ratio (SNR)
Measured over Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.
+6 more outcomes measured

Conditions

Healthy (Controls)
Healthy Volunteers
Neuroendocrine (NE) Tumors

Explore related trials

Healthy VolunteersNeuroendocrine Neoplasm

Where it's being run

1 sites across 1 states
New Jersey1

Who to contact

Barbara Blanchfield
[email protected]
9732554955
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Signal-to-Noise Ratio (SNR)Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.

    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)

  • Contrast-to-Noise Ratio (CNR)Time Frame: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.

    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)

  • Coefficient of Variation (COV)Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.

    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 (%)

  • Spatial Resolution (Full Width at Half Maximum - FWHM)Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.

    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)

  • Target-to-Background Ratio (TBR)Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.

    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)

  • Qualitative Image Quality Score (Likert Scale)Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.

    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)

  • Inter-reader Agreement (Weighted Kappa Statistics)Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.

    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)