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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	1 Year - 21 Years
Gender	All

More Inclusion & Exclusion 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 above expected values for age and gender.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05553041
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Early Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Children's Hospital of Philadelphia
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Ali Nabavizadeh, MD
Principal Investigator Affiliation	Children's Hospital of Philadelphia
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioma, High Grade Glioma, Glioma, Malignant, Glioma Intracranial, Diffuse Glioma

Additional Details

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.

Arms & Interventions

Arms

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

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

Interventions

Drug: - 18F-Fluciclovine PET-MRI

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

Status

Recruiting

Address

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

Site Contact

Ali Nabavizadeh, MD

nabavizadehs@chop.edu

215-590-1000

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