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New PET tracer aims to catch a dangerous transplant complication early

NCT ID NCT03367962

Diagnosis Sponsor: CellSight Technologies, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This small Phase 1 study tested whether a radioactive tracer called [18F]F-AraG can help detect graft-versus-host disease (GVHD) using PET scans. GVHD is a serious condition where donor immune cells attack the recipient's body after a stem cell transplant. The study involved 9 patients who were either suspected of having acute GVHD or at high risk for it. Researchers compared the PET scan images with biopsy results to see if the tracer could identify areas of T cell activity linked to the disease.

What this could mean

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

Active substance
[18F]F-AraG (a radioactive tracer for PET scans)
What this could lead to
If successful, this could lead to a non-invasive way to detect graft-versus-host disease earlier and more accurately than current methods.
What could go wrong
This was a very small, early-phase study with only 9 participants, and it did not include healthy volunteers as planned. The results may not apply to all patients, and the tracer is not yet proven as a reliable diagnostic tool.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

9 people

The number who actually took part.

Started

May 2018

Finished

Oct 2023

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

21 years and older

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. Must be 21 years of age or older. 2. Must understand and voluntarily have signed an Informed Consent after its contents have been fully explained. 1. For patients highly suspected to have aGVHD and requiring systemic therapy, informed consent should be signed after biopsy taken to support clinical diagnosis. 2. For patients at high risk for developing aGVHD, informed consent should be signed prior to transplant. 3. For healthy volunteers only: Must have no known medical problems that would make undergoing the scan hazardous to the health of the patient or interfere with the results. In particular subjects should not have any cardiac or immunological disorders as these would likely affect the scan results. Subjects should have had a full physical exam within 6 months of the study. If healthy volunteers have not had a full medical exam within 6 months of the study, one of the nuclear medicine physicians will conduct the medical exam prior to any study procedures. 4. For patients highly suspected to have aGVHD and requiring systemic therapy only: Taking steroid treatment for suspected aGVHD for 3 days or less. 5. For patients at high risk for developing aGVHD only: Recipients of myeloablative or reduced intensity allogeneic transplants using either bone marrow or peripheral blood stem cells from HLA-matched or HLA-mismatched related or unrelated donors (protocols 9142, 9022, 9924) who have not yet been placed on any therapy for acute GVHD. Exclusion Criteria: 1. Pregnant or nursing 2. Individuals with known or suspected substance abuse, obtained by self-reporting. 3. Uncontrolled infection 4. Relapsed/persistent malignancy 5. Currently receiving immunotherapy

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Conditions

The condition(s) this trial relates to.

acute graft versus host disease graft versus host disease

As listed by the trial registrant

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

Graft versus host disease

Contacts and locations

Locations

  • Stanford Hospital

    Stanford, California, 94305, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.