RECRUITING

Evaluation of 18F-Fluciclovine Positron Emission Tomography - Magnetic Resonance Imaging (PET-MRI) in LGG

Conditions

Glioma Low-grade Glioma Low Grade Glioma of Brain Glioma, Malignant Glioma Intracranial 18F-Fluciclovine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Evaluation of 18F-Fluciclovine PET-MRI as a Biomarker of Response in Pediatric and Young Adult Patients With Low Grade Gliomas (LGG)

Quick Facts

Study Start:2025-03-03

Study Completion:2026-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05555550

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Year to 21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
* LGG including the brainstem and supratentorial only , (WHO grade I-II), confirmed by biopsy unless in Neurofibromatosis type 1 (NF1) participants with classic appearance * Participants must have evaluable disease (1x1 cm tumor on MRI; enhancing + non-enhancing tumor) * Scheduled to receive systemic therapy * 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 between ≥ 1 years but ≤21 years at time of study registration	1. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician 2. Pregnant participants 3. Patient who would require sedation or anesthesia for imaging beyond 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.

Inclusion Criteria

Exclusion Criteria

* LGG including the brainstem and supratentorial only , (WHO grade I-II), confirmed by biopsy unless in Neurofibromatosis type 1 (NF1) participants with classic appearance
* Participants must have evaluable disease (1x1 cm tumor on MRI; enhancing + non-enhancing tumor)
* Scheduled to receive systemic therapy
* 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 between ≥ 1 years but ≤21 years at time of study registration

1. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
2. Pregnant participants
3. Patient who would require sedation or anesthesia for imaging beyond 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.

Contacts and Locations

Study Contact

Mariam Aboian, MD, PhD

CONTACT

215-510-7661

aboianm@chop.edu

Nazanin Maleki, MD

CONTACT

malekin@chop.edu

Principal Investigator

Mariam Aboian, MD,PhD

PRINCIPAL_INVESTIGATOR

The Children s Hospital of Philadelphia

Study Locations (Sites)

The Children s Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: Children's Hospital of Philadelphia

Mariam Aboian, MD,PhD, PRINCIPAL_INVESTIGATOR, The Children s Hospital of Philadelphia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-03

Study Completion Date2026-09

Study Record Updates

Study Start Date2025-03-03

Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

Glioma
Low-grade Glioma
Low Grade Glioma of Brain
Glioma, Malignant
Glioma Intracranial
18F-Fluciclovine

Additional Relevant MeSH Terms

Glioma
Low-grade Glioma
Low Grade Glioma of Brain
Glioma, Malignant
Glioma Intracranial