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New treatment option for Glioma
Official title Evaluation of 18F-Fluciclovine Positron Emission Tomography - Magnetic Resonance Imaging (PET-MRI) in LGG
ClinicalTrials.gov ID: NCT05555550
What this study is testing
What is 18F-Fluciclovine?
18F-Fluciclovine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for glioma.
Also referred to as Axumin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 21
You may be able to join if
- 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...
- Age: Participants must be ≥ 1 years but ≤21 years of age at registration
You likely can't join if
- 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 a history of abnormal kidney function or creatinine \>= CTCAE v5.0 grade 2 at time of study registration.
- Participants with primary tumors of the spinal cord.
See the full eligibility criteria
- 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...
- 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.
- 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 a history of abnormal kidney function or creatinine \>= CTCAE v5.0 grade 2 at time of study registration.
- Participants with primary tumors of the spinal cord.
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.