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New treatment option for Glioma
Official title 18F-Fluciclovine PET-MRI in High-grade Glioma
ClinicalTrials.gov ID: NCT05553041
What this study is testing
What is 18F-Fluciclovine PET-MRI?
18F-Fluciclovine PET-MRI 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®) 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.
- 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
- 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...
- 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...
You likely can't join if
- 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.
- 6\. Participants with a history of abnormal kidney function or creatinine \>= CTCAE v5.0 grade 2 at time of study registration. 7\. Participants with...
See the full eligibility criteria
- 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...
- 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.
- 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.
- 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.
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.