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New imaging test may help doctors spot real tumor growth in kids with brain cancer

NCT ID NCT05553041

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether a special PET scan called 18F-Fluciclovine can help doctors tell the difference between actual tumor growth and harmless changes caused by treatment in children with high-grade glioma. About 30 children aged 1 to 21 will receive the scan after radiation therapy. The goal is to improve diagnosis and avoid unnecessary procedures.

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.

Started

Aug 2024

Expected to finish

Dec 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\. Histopathology-proven HGG (WHO grade III-IV) or DMG (WHO grade IV) or, in the case of DMG of the pons, imaging that is characteristic of Diffuse intrinsic pontine gliomas (DIPG) (diffusely infiltrating \>=2/3 of the pons). * 2\. Measurable disease, measuring at least 1x1 cm. * 3\. Life expectancy of greater than 8 weeks. * 4\. Age \> 1 years but \< 21 years of age at enrollment. For those without planned surgery: * 1\. Participants with clinical and/or radiographic suspicion of True progression (TP) or Pseudoprogression (PsP) during radiation but yet to have the initial post-radiation MRI scan. or * 2\. Participants with suspicion for TP or PsP on first post-radiation MRI For those with planned surgery: * 1\. Clinical or radiographic suspicion of tumor progression with plan to undergo surgery or biopsy. Exclusion Criteria: * 1\. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician. * 2\. Pregnant or breastfeeding participants. * 3\. Participant who would require sedation or anesthesia for imaging beyond standard of care (SOC). * 4\. Participants who weigh less than 8 kg. * 5\. Participants who cannot avoid contact with a pregnant woman or infant for at least 12 hours following injection. * 6\. Participants with a history of abnormal kidney function or creatinine \>= CTCAE v5.0 grade 2 at time of study registration. 7\. Participants with primary tumors of the spinal cord.

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Conditions

The condition(s) this trial relates to.

diffuse astrocytoma diffuse intrinsic pontine glioma glioma malignant glioma

As listed by the trial registrant

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

Diffuse glioma GLIOMA Glioma intracranial Glioma, malignant High 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

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

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