Evaluation of 18F-Fluciclovine Positron Emission Tomography - Magnetic Resonance Imaging (PET-MRI) in LGG

NCT ID: NCT05555550

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-29
• Study Completion Date: 2027-09-30

Brief Summary

The purpose of this study is to see if 18F-Fluciclovine (Axumin®) is useful and safe in the management of children with Low Grade Gliomas (LGG). Imaging with 18F-Fluciclovine PET-MRI will be performed prior to initiation of therapy for LGG, and then 3 months, and 1 year after starting therapy. Changes in 18F-Fluciclovine uptake will be compared to changes in MRI measurements at 3 months and 1 year as compared to baseline.

Conditions

Glioma; Low-grade Glioma; Low Grade Glioma of Brain; Glioma, Malignant; Glioma Intracranial

Study Design

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

Study Groups

18F-Fluciclovine

18F-Fluciclovine PET-MRI

Group Type: EXPERIMENTAL

18F-Fluciclovine

Intervention Type: DRUG

18F-Fluciclovine will be injected via IV prior to PET-MRI imaging

Interventions

18F-Fluciclovine

18F-Fluciclovine will be injected via IV prior to PET-MRI imaging

Intervention Type: DRUG

Other Intervention Names

Axumin

Eligibility Criteria

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.

• 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

The Children s Hospital of Philadelphia

Locations

The 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

21NO104

Identifier Type: OTHER

Identifier Source: secondary_id

21-019390

Identifier Type: -

Identifier Source: org_study_id