NCT05555550RecruitingEarly phase 1
Evaluation of 18F-Fluciclovine Positron Emission Tomography - Magnetic Resonance Imaging (PET-MRI) in LGG
Evaluation of 18F-Fluciclovine PET-MRI as a Biomarker of Response in Pediatric and Young Adult Patients With Low Grade Gliomas (LGG)
Source: ClinicalTrials.gov · Last updated 22 Sept 2026
Brief summary (registry, in English)
The purpose of this study is to see if 18F-Fluciclovine (Axumin®) is useful and safe in the management of children with Low Grade Gliomas (LGG). Imaging with 18F-Fluciclovine PET-MRI will be performed prior to initiation of therapy for LGG, and then 3 months, and 1 year after starting therapy. Changes in 18F-Fluciclovine uptake will be compared to changes in MRI measurements at 3 months and 1 year as compared to baseline.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 22 Sept 2022
- Start date
- 29 Nov 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- Children's Hospital of Philadelphia
- Diseases
- Childhood cancers
- NCT number
- NCT05555550
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 30
- From 29 Nov 2026 to the primary completion date, Dec 2027
- 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
- Participants with a history of abnormal kidney function or creatinine \>= CTCAE v5.0 grade 2 at time of study registration.
Other
- Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
- Pregnant participants
- Participants who weigh less than 8 kg.
- Participants who cannot avoid contact with a pregnant woman or infant for at least 12 hours following injection.
- Participants with primary tumors of the spinal cord.
Who the study is looking for
- LGG including the brainstem and supratentorial only (WHO grade I-II), confirmed by biopsy unless in NF1 participants with classic appearance.
- Participants must have evaluable disease (1x1 cm tumor on MRI)
- Scheduled to receive systemic therapy for LGG
- Performance Score: Karnofsky ≥ 50 for participants \> 16 years of age and Lansky ≥ 50 for participants ≤ 16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
- Age: Participants must be ≥ 1 years but ≤21 years of age at registration
- Being on a treatment regimen does not exclude a subject from enrollment.
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 |
|---|---|---|---|
| The 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.