18F-Fluciclovine PET-MRI in High-grade Glioma

NCT ID: NCT05553041

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-07
• Study Completion Date: 2027-12-31

Brief Summary

The purpose of this study is to see if 18F-fluciclovine (Axumin®) PET imaging is useful and safe in the management of children with High Grade Gliomas. Investigators seek to determine if this imaging will help doctors tell the difference between tumor growth (progression) and other tumor changes that can occur after treatment.

Detailed Description

Following radiation and immunotherapy, many pediatric participants with high-grade gliomas (HGG), including diffuse midline glioma (DMG), demonstrate radiographic findings suspicious of disease progression. Differentiating post-treatment changes from true tumor progression is paramount to clinical decision-making, as true tumor progression may warrant a change in treatment, while post-treatment changes are typically not an indication to change treatment. Unfortunately, conventional MRI cannot reliably distinguish between true progression and post-treatment changes. Therefore, finding a physiological correlate to delineate true progression from pseudo-progression is critical.

The overall objective of this current application is to evaluate 18F-fluciclovine PET imaging as a diagnostic biomarker for tumor progression compared to post-treatment changes in pediatric HGG. The long-term goal of this research is to accurately differentiate tumor progression from post-treatment changes in pediatric HGG using 18F-fluciclovine PET imaging.

Conditions

Glioma; High Grade Glioma; Glioma, Malignant; Glioma Intracranial; Diffuse Glioma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

18F-Fluciclovine PET-MRI in pediatric HGG or DMG participants

Single intravenous administration of 18F fluciclovine for PET-MRI Scan

Group Type: EXPERIMENTAL

18F-Fluciclovine PET-MRI

Intervention Type: DRUG

18F-Fluciclovine will be injected via IV prior to Positron emission tomography (PET)-Magnetic resonance imaging (MRI)

Interventions

18F-Fluciclovine PET-MRI

18F-Fluciclovine will be injected via IV prior to Positron emission tomography (PET)-Magnetic resonance imaging (MRI)

Intervention Type: DRUG

Other Intervention Names

Axumin

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Blue Earth Diagnostics

INDUSTRY

Sponsor Role: collaborator

Dragon Master Foundation

UNKNOWN

Sponsor Role: collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mariam Aboian, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

children's hospital of philadelphia

Locations

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mariam Aboian, MD, PhD

Role: CONTACT

aboianm@chop.edu

215-510-7661

Nazanin Maleki, MD

Role: CONTACT

malekin@chop.edu

Facility Contacts

Mariam Aboian, MD, PhD

Role: primary

aboianm@chop.edu

215-510-7661

Nazanin Maleki, MD

Role: backup

malekin@chop.edu

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Other Identifiers

21-019514

Identifier Type: -

Identifier Source: org_study_id