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

Children's Hospital of Philadelphia (CHOP)

Status and phase: Enrolling; Early Phase 1

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

Treatments: Drug: 18F-Fluciclovine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05555550

21NO104 (Other Identifier)

21-019390

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 1 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

18F-Fluciclovine

Experimental group

Description:

18F-Fluciclovine PET-MRI

Treatment:

Drug: 18F-Fluciclovine