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

Official title

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

Overview

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.

Interventions

• Drug 18F-Fluciclovine
  18F-Fluciclovine will be injected via IV prior to PET-MRI imaging

Primary outcome measures

• Compare change in standardized uptake value parameters (SUVmax and SUVpeak) on metabolic tumor volume in 18F-Fluciclovine PET [Time frame: 1 year]
• Compare changes in pretreatment tumor measurement on MRI in pediatric participants who initiate systemic treatment for LGG [Time frame: 1 year]

Secondary outcome measures (1)

• Safety of 18F-Fluciclovine [Time frame: 13 months]

Eligibility criteria

Inclusion 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 considered ambulatory for the purpose of assessing the performance score.
• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

United States · 1 center

• The Children s Hospital of Philadelphia — Philadelphia

Publications

• Jones DTW, Kieran MW, Bouffet E, Alexandrescu S, Bandopadhayay P, Bornhorst M, Ellison D, Fangusaro J, Fisher MJ, Foreman N, Fouladi M, Hargrave D, Hawkins C, Jabado N, Massimino M, Mueller S, Perilongo G, Schouten van Meeteren AYN, Tabori U, Warren K, Waanders AJ, Walker D, Weiss W, Witt O, Wright K, Zhu Y, Bowers DC, Pfister SM, Packer RJ. Pediatric low-grade gliomas: next biologically driven st PMID 29016845
• de Blank P, Bandopadhayay P, Haas-Kogan D, Fouladi M, Fangusaro J. Management of pediatric low-grade glioma. Curr Opin Pediatr. 2019 Feb;31(1):21-27. doi: 10.1097/MOP.0000000000000717. PMID 30531227
• Fangusaro J, Onar-Thomas A, Young Poussaint T, Wu S, Ligon AH, Lindeman N, Banerjee A, Packer RJ, Kilburn LB, Goldman S, Pollack IF, Qaddoumi I, Jakacki RI, Fisher PG, Dhall G, Baxter P, Kreissman SG, Stewart CF, Jones DTW, Pfister SM, Vezina G, Stern JS, Panigrahy A, Patay Z, Tamrazi B, Jones JY, Haque SS, Enterline DS, Cha S, Fisher MJ, Doyle LA, Smith M, Dunkel IJ, Fouladi M. Selumetinib in pae PMID 31151904
• Ater JL, Xia C, Mazewski CM, Booth TN, Freyer DR, Packer RJ, Sposto R, Vezina G, Pollack IF. Nonrandomized comparison of neurofibromatosis type 1 and non-neurofibromatosis type 1 children who received carboplatin and vincristine for progressive low-grade glioma: A report from the Children's Oncology Group. Cancer. 2016 Jun 15;122(12):1928-36. doi: 10.1002/cncr.29987. Epub 2016 Apr 8. PMID 27061921
• Songmen S, Nepal P, Olsavsky T, Sapire J. Axumin Positron Emission Tomography: Novel Agent for Prostate Cancer Biochemical Recurrence. J Clin Imaging Sci. 2019 Nov 6;9:49. doi: 10.25259/JCIS_139_2019. eCollection 2019. PMID 31819826
• Wakabayashi T, Iuchi T, Tsuyuguchi N, Nishikawa R, Arakawa Y, Sasayama T, Miyake K, Nariai T, Narita Y, Hashimoto N, Okuda O, Matsuda H, Kubota K, Ito K, Nakazato Y, Kubomura K. Diagnostic Performance and Safety of Positron Emission Tomography Using 18F-Fluciclovine in Patients with Clinically Suspected High- or Low-grade Gliomas: A Multicenter Phase IIb Trial. Asia Ocean J Nucl Med Biol. 2017 Win PMID 28840134
• Shoup TM, Olson J, Hoffman JM, Votaw J, Eshima D, Eshima L, Camp VM, Stabin M, Votaw D, Goodman MM. Synthesis and evaluation of [18F]1-amino-3-fluorocyclobutane-1-carboxylic acid to image brain tumors. J Nucl Med. 1999 Feb;40(2):331-8. PMID 10025843
• Michaud L, Beattie BJ, Akhurst T, Dunphy M, Zanzonico P, Finn R, Mauguen A, Schoder H, Weber WA, Lassman AB, Blasberg R. 18F-Fluciclovine (18F-FACBC) PET imaging of recurrent brain tumors. Eur J Nucl Med Mol Imaging. 2020 Jun;47(6):1353-1367. doi: 10.1007/s00259-019-04433-1. Epub 2019 Aug 15. PMID 31418054

Identifiers

NCT: NCT05555550 · 21-019390 · 21NO104

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗