Evaluating a new imaging method for low-grade brain tumors in children
Evaluation of 18F-Fluciclovine PET-MRI as a Biomarker of Response in Pediatric and Young Adult Patients With Low Grade Gliomas (LGG)
EARLY_PHASE1 · Children's Hospital of Philadelphia · NCT05555550
This study is testing a new imaging method to see if it can help doctors better monitor and manage low-grade brain tumors in children.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 1 Year to 21 Years |
| Sex | All |
| Sponsor | Children's Hospital of Philadelphia (other) |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT05555550 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and effectiveness of 18F-Fluciclovine Positron Emission Tomography-Magnetic Resonance Imaging (PET-MRI) in managing low-grade gliomas (LGG) in children. Participants will undergo imaging with 18F-Fluciclovine PET-MRI before starting therapy, and again at three months and one year after treatment initiation. The study will compare changes in 18F-Fluciclovine uptake with MRI measurements to evaluate the imaging method's utility in monitoring tumor response. The goal is to improve the management of LGG in pediatric patients.
Who should consider this trial
Good fit: Ideal candidates are children aged 1 to 21 years with confirmed low-grade gliomas scheduled to receive systemic therapy.
Not a fit: Patients who cannot tolerate imaging procedures or those with conditions that prevent them from undergoing the necessary scans may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the monitoring and treatment of low-grade gliomas in children, leading to better patient outcomes.
How similar studies have performed: Other studies using advanced imaging techniques for gliomas have shown promise, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria 1. LGG including the brainstem and supratentorial only (WHO grade I-II), confirmed by biopsy unless in NF1 participants with classic appearance. 2. Participants must have evaluable disease (1x1 cm tumor on MRI) 3. Scheduled to receive systemic therapy for LGG 4. 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. 5. Age: Participants must be ≥ 1 years but ≤21 years of age at registration 6. Being on a treatment regimen does not exclude a subject from enrollment. Exclusion Criteria 1. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician 2. Pregnant participants 3. Participants who weigh less than 8 kg. 4. Participants who cannot avoid contact with a pregnant woman or infant for at least 12 hours following injection. 5. Participants with a history of abnormal kidney function or creatinine \>= CTCAE v5.0 grade 2 at time of study registration. 6. Participants with primary tumors of the spinal cord.
Where this trial is running
Philadelphia, Pennsylvania
- The Children s Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: Mariam Aboian, MD,PhD — The Children s Hospital of Philadelphia
- Study coordinator: Mariam Aboian, MD, PhD
- Email: aboianm@chop.edu
- Phone: 215-510-7661
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Glioma, Low-grade Glioma, Low Grade Glioma of Brain, Glioma, Malignant, Glioma Intracranial, 18F-Fluciclovine