Clinical trial · Interventional
18F-Fluciclovine PET-MRI in High-grade Glioma
Evaluation of 18F-Fluciclovine PET-MRI to Differentiate Tumor Progression From Post-treatment Changes in Pediatric High-grade Glioma (HGG)
NCT05553041CI-TRIAL-00098438recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Glioma | Diffuse Glioma | ONTOLOGY_EXACT | 0.98 |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
| Glioma Intracranial | — | UNRESOLVED | — |
| Glioma, Malignant | Malignant Glioma | ALIAS | 0.90 |
| High Grade Glioma | High-Grade Glioma, NOS | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-Fluciclovine PET-MRI | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 18F-Fluciclovine PET-MRI in pediatric HGG or DMG participants
- description
- Single intravenous administration of 18F fluciclovine for PET-MRI Scan
- interventionNames
- Drug: 18F-Fluciclovine PET-MRI
Primary outcomes (2)
- measure
- Image analysis
- timeFrame
- 6 months
- description
- Comparison of Standardized uptake value (SUV) max, SUV peak, and uptake kinetics post radiation between participants who experience true progression versus those who experience pseudoprogression as confirmed by routine imaging.
- measure
- Histopathology analysis
- timeFrame
- 4 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion 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 pons). * 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. Exclusion Criteria: * 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.
References
Publications (28)
- BACKGROUNDCalmon R, Puget S, Varlet P, Dangouloff-Ros V, Blauwblomme T, Beccaria K, Grevent D, Sainte-Rose C, Castel D, Debily MA, Dufour C, Bolle S, Dhermain F, Saitovitch A, Zilbovicius M, Brunelle F, Grill J, Boddaert N. Cerebral blood flow changes after radiation therapy identifies pseudoprogression in diffuse intrinsic pontine gliomas. Neuro Oncol. 2018 Jun 18;20(7):994-1002. doi: 10.1093/neuonc/nox227. PMID 29244086
- BACKGROUNDCarceller F, Fowkes LA, Khabra K, Moreno L, Saran F, Burford A, Mackay A, Jones DT, Hovestadt V, Marshall LV, Vaidya S, Mandeville H, Jerome N, Bridges LR, Laxton R, Al-Sarraj S, Pfister SM, Leach MO, Pearson AD, Jones C, Koh DM, Zacharoulis S. Pseudoprogression in children, adolescents and young adults with non-brainstem high grade glioma and diffuse intrinsic pontine glioma. J Neurooncol. 2016 Aug;129(1):109-21. doi: 10.1007/s11060-016-2151-8. Epub 2016 May 14. PMID 27180091
- BACKGROUNDVajapeyam S, Brown D, Billups C, Patay Z, Vezina G, Shiroishi MS, Law M, Baxter P, Onar-Thomas A, Fangusaro JR, Dunkel IJ, Poussaint TY. Advanced ADC Histogram, Perfusion, and Permeability Metrics Show an Association with Survival and Pseudoprogression in Newly Diagnosed Diffuse Intrinsic Pontine Glioma: A Report from the Pediatric Brain Tumor Consortium. AJNR Am J Neuroradiol. 2020 Apr;41(4):718-724. doi: 10.3174/ajnr.A6499. Epub 2020 Apr 2. PMID 32241771
- BACKGROUNDBhutia YD, Babu E, Ramachandran S, Ganapathy V. Amino Acid transporters in cancer and their relevance to "glutamine addiction": novel targets for the design of a new class of anticancer drugs. Cancer Res. 2015 May 1;75(9):1782-8. doi: 10.1158/0008-5472.CAN-14-3745. Epub 2015 Apr 8. PMID 25855379
- BACKGROUNDGalldiks N, Law I, Pope WB, Arbizu J, Langen KJ. The use of amino acid PET and conventional MRI for monitoring of brain tumor therapy. Neuroimage Clin. 2016 Dec 18;13:386-394. doi: 10.1016/j.nicl.2016.12.020. eCollection 2017. PMID 28116231
- BACKGROUNDOka S, Hattori R, Kurosaki F, Toyama M, Williams LA, Yu W, Votaw JR, Yoshida Y, Goodman MM, Ito O. A preliminary study of anti-1-amino-3-18F-fluorocyclobutyl-1-carboxylic acid for the detection of prostate cancer. J Nucl Med. 2007 Jan;48(1):46-55.