NCT05553041RecruitingEarly phase 1
18F-Fluciclovine PET-MRI in High-grade Glioma
Evaluation of 18F-Fluciclovine PET-MRI to Differentiate Tumor Progression From Post-treatment Changes in Pediatric High-grade Glioma (HGG)
Source: ClinicalTrials.gov · Last updated 4 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 21 Sept 2022
- Start date
- 7 Aug 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- Children's Hospital of Philadelphia
- Diseases
- Childhood cancers
- NCT number
- NCT05553041
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 30
- From 7 Aug 2024 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 1 year to 21 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.