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

Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05553041
• Other study ID #: 21-019514
• Status: Recruiting
• Phase: Early Phase 1
• Start date: August 7, 2023
• Est. completion date: December 2026

Study information

• Verified date: August 2023
• Source: Children's Hospital of Philadelphia
• Contact: Ali Nabavizadeh
• Phone: 215-590-1000
• Email: nabavizadehs[@]chop.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 21 Years

Eligibility

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 above expected values for age and gender.

Related Conditions & MeSH terms

• Diffuse Glioma
• Glioma
• Glioma Intracranial
• Glioma, Malignant
• High Grade Glioma

Intervention

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

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Blue Earth Diagnostics, Inc, Dragon Master Foundation

Country where clinical trial is conducted

United States, 

References & Publications (28)

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Primary	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.	4 weeks
Secondary	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	6 months