Health TrialsbyHealthPanel

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

ConditionsGliomaHigh Grade GliomaGlioma, MalignantGlioma IntracranialDiffuse Glioma
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age1-21
SponsorChildren's Hospital of Philadelphia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 18F-Fluciclovine PET-MRI

    Drug

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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: 18F-Fluciclovine PET-MRI in pediatric HGG or DMG participantsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Image analysis

Comparison of Standardized uptake value (SUV) max, SUV peak, and uptake kinetics post radiation between participants who experience true progression versus those who experience pseudoprogression as confirmed by routine imaging.

Time frame
6 months
2

Histopathology analysis

Evaluation of SUV uptake post radiation in participants with planned biopsy or resection who experience true progression versus those who experience pseudoprogression as confirmed by histopathology.

Time frame
4 weeks

Secondary outcomes

1

Safety of 18F-Fluciclovine

The Safety profile of 18F-Fluciclovine PET in pediatric HGG participants will be assessed based on CTCAE 5.0 toxicity experienced after administration of 18F-Fluciclovine

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital of Philadelphia

Lead sponsor

Blue Earth Diagnostics

Collaborator

Dragon Master Foundation

Collaborator

Source ClinicalTrials.gov
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