Can a new PET tracer reveal the Body's immune battles?

NCT ID NCT07774650

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 19, 2026 · Last updated Sep 02, 2026 · Updated 3 times

Summary

This early-stage trial is testing an experimental imaging agent that targets granzyme B, a protein released by immune cells during activity. The goal is to see how this tracer moves through the body and how much radiation it delivers, using PET/CT scans and blood samples. Up to 12 healthy adults will receive a single injection and be monitored for about 24 hours, with a follow-up call a week later. The study aims to determine if this tracer is safe and could be used in the future to visualize immune responses in various diseases.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Granzyme-B targeted [Cu-64]-labeled PET radiotracer
What this could lead to
If successful, this could lead to a new imaging tool to visualize immune activity in the body, potentially improving diagnosis and monitoring of diseases like cancer and autoimmune conditions.
What could go wrong
This is an early, small study focused on safety and imaging properties, not treatment. The tracer may not distribute as expected or may not be suitable for future clinical use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 12 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adult male or female participants 18-60 years of age judged to be in good health by the Investigator 2. No clinically significant laboratory abnormalities; all tests of liver and kidney function within normal limits 3. Capable of giving signed informed consent, which includes compliance with requirements and restrictions listed in the ICF and this protocol 4. Female participants of childbearing potential and male participants who are fertile and have female partners of childbearing potential must agree to use adequate birth control throughout the study to the conclusion of follow-up. Exclusion Criteria: 1. Pregnant or breast-feeding female participants (female participants of childbearing potential must have negative pregnancy tests at Screening and pre-dose Day 0) 2. Inadequate venous access (at least two distinct access sites allowing for separate test agent administration and PK blood sampling are required) 3. Inability or unwillingness to undergo serial PET/CT imaging 4. Active infection or malignancy 5. Known or suspected inflammatory, autoimmune or fibrotic disease 6. Major surgery or other intensive medical treatment in the 3 months prior to planned study injection, as assessed by the investigator 7. Received a radioisotope within 7 physical half-lives of that radioisotope prior to planned study injection 8. Known allergy/hypersensitivity to PET/CT tracers or compounds similar to GzmB-Targeted Compounds 9. Concurrent participation in a clinical trial of investigational product(s) 10. Participation in other research protocols or clinical care where there was radiation exposure such that the exposure from the last year, in addition to the radiation exposure expected from participation in this clinical study, exceeds the effective dose of 50 mSv, which would be above the acceptable annual limit established by US federal guidelines 11. Significant intercurrent illness or psychiatric illness/social situation that could place the participant at undue risk during study participation, significantly alter study outcomes, or affect participant compliance with study requirements for dosing and evaluation, as determined by the investigator

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

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    Open the record ↗

  4. A doctor treating you

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Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Xing Imaging

    RECRUITING

    New Haven, Connecticut, 06510, United States

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