NCT05553041 18F-Fluciclovine PET-MRI in High-grade Glioma
| NCT ID | NCT05553041 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Children's Hospital of Philadelphia |
| Condition | Glioma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-08-07 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2024-08-07 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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 \>= CTCAE v5.0 grade 2 at time of study registration. 7\. Participants with primary tumors of the spinal cord.
Contact & Investigator
Mariam Aboian, MD,PhD
PRINCIPAL INVESTIGATOR
Children's Hospital of Philadelphia
Frequently Asked Questions
Who can join the NCT05553041 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 21 Years, studying Glioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05553041 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05553041 currently recruiting?
Yes, NCT05553041 is actively recruiting participants. Contact the research team at aboianm@chop.edu for enrollment information.
Where is the NCT05553041 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT05553041 clinical trial?
NCT05553041 is sponsored by Children's Hospital of Philadelphia. The principal investigator is Mariam Aboian, MD,PhD at Children's Hospital of Philadelphia. The trial plans to enroll 30 participants.