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New PET-MRI tracer could sharpen view of Kids' brain tumors

NCT ID NCT05555550

Diagnosis Sponsor: Children's Hospital of Philadelphia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial at Children's Hospital of Philadelphia is testing whether a radioactive tracer called 18F-Fluciclovine (Axumin) can improve PET-MRI scans for children and young adults with low-grade glioma. About 30 participants will receive the tracer before starting treatment, then again at 3 months and 1 year. The goal is to see if changes in tracer uptake better reflect tumor response than standard MRI alone, while also checking safety.

What this could mean

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

Active substance
18F-Fluciclovine (Axumin), a radioactive tracer injected before PET-MRI imaging
What this could lead to
If successful, this imaging method could help doctors see sooner whether a child's brain tumor is responding to treatment, potentially guiding therapy adjustments.
What could go wrong
This is a very early, small study (30 participants) focused on imaging accuracy, not treatment. The tracer may not prove more useful than standard MRI, and safety in children is still being checked.

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 30 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

1 year to 21 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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. LGG including the brainstem and supratentorial only (WHO grade I-II), confirmed by biopsy unless in NF1 participants with classic appearance. 2. Participants must have evaluable disease (1x1 cm tumor on MRI) 3. Scheduled to receive systemic therapy for LGG 4. Performance Score: Karnofsky ≥ 50 for participants \> 16 years of age and Lansky ≥ 50 for participants ≤ 16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score. 5. Age: Participants must be ≥ 1 years but ≤21 years of age at registration 6. Being on a treatment regimen does not exclude a subject from enrollment. Exclusion Criteria 1. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician 2. Pregnant participants 3. Participants who weigh less than 8 kg. 4. Participants who cannot avoid contact with a pregnant woman or infant for at least 12 hours following injection. 5. Participants with a history of abnormal kidney function or creatinine \>= CTCAE v5.0 grade 2 at time of study registration. 6. Participants with primary tumors of the spinal cord.

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Conditions

The condition(s) this trial relates to.

glioma low grade glioma malignant glioma

As listed by the trial registrant

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

GLIOMA Glioma intracranial Glioma, malignant Low grade glioma of brain Low-grade glioma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

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

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Children s Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

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