Using 18F-fluciclovine PET-MRI to assess high-grade gliomas in children

Evaluation of 18F-Fluciclovine PET-MRI to Differentiate Tumor Progression From Post-treatment Changes in Pediatric High-grade Glioma (HGG)

This study is testing a special imaging technique to see if it can help doctors tell the difference between real tumor growth and changes after treatment in children with high-grade brain tumors.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 1 Year to 21 Years
• Sex: All
• Sponsor: Children's Hospital of Philadelphia (other)
• Drugs / interventions: radiation, immunotherapy
• Locations: 1 site (Philadelphia, Pennsylvania)
• Trial ID: NCT05553041 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and usefulness of 18F-fluciclovine PET imaging in managing pediatric patients with high-grade gliomas (HGG). The goal is to differentiate between true tumor progression and post-treatment changes that can mimic progression after radiation and immunotherapy. By utilizing this advanced imaging technique, researchers aim to improve clinical decision-making regarding treatment options for these patients. The study focuses on children aged 1 to 21 years with histopathologically confirmed HGG or diffuse midline glioma.

Who should consider this trial

Good fit: Ideal candidates are children aged 1 to 21 years with histopathology-proven high-grade gliomas or diffuse midline gliomas.

Not a fit: Patients who cannot tolerate imaging procedures or are pregnant may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate diagnoses and better treatment decisions for children with high-grade gliomas.

How similar studies have performed: While the use of PET imaging in gliomas is being explored, this specific application of 18F-fluciclovine PET-MRI in pediatric high-grade gliomas is relatively novel.

Eligibility criteria

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.

Where this trial is running

Philadelphia, Pennsylvania

• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: Mariam Aboian, MD,PhD — Children's Hospital of Philadelphia
• Study coordinator: Mariam Aboian, MD, PhD

Conditions: Glioma, High Grade Glioma, Glioma, Malignant, Glioma Intracranial, Diffuse Glioma, 18F fluciclovine