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GliomaEarly Phase 1NCT05555550

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

A Early Phase 1 study testing 18F-Fluciclovine in people with Glioma and Low-grade Glioma, run by Children's Hospital of Philadelphia at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 1 year to 21 years
What is being tested?
18F-Fluciclovine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
29 Nov 2026to Sep 2028
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mariam Aboian, MD, PhD contact

215-510-7661

aboianm@chop.edu

Nazanin Maleki, MD contact

malekin@chop.edu

United States1 site, 1 recruiting

  • The Children s Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

    Mariam Aboian, MD, PhD, 215-510-7661, aboianm@chop.edu

    Nazanin Maleki, MD, malekin@chop.edu

    Recruiting

Other trials in United States

About this study

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

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.

Being tested
18F-Fluciclovine
Keywords
Glioma, Low-grade Glioma, Low Grade Glioma of Brain, Glioma, Malignant, Glioma Intracranial, 18F-Fluciclovine
Medical subject headings
Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 18F-FluciclovineDrug

    Also called Axumin

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

Study groups in NCT05555550
Study groupRoleWhat they receive
18F-FluciclovineExperimental18F-Fluciclovine PET-MRI
Receives: Drug: 18F-Fluciclovine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compare change in standardized uptake value parameters (SUVmax and SUVpeak) on metabolic tumor volume in 18F-Fluciclovine PET

    To identify change in the standardized uptake value (SUV) parameters (SUVmax, SUVpeak) for the 18F-Fluciclovine PET scan

    Measured: 1 year

  2. Compare changes in pretreatment tumor measurement on MRI in pediatric participants who initiate systemic treatment for LGG

    Calculate the change in tumor measurement on MRI

    Measured: 1 year

Secondary outcomes (1)

  1. Safety of 18F-Fluciclovine

    The Safety profile of 18F-Fluciclovine PET in pediatric LGG participants will be accessed by the CTCAE 5.0 toxicity experienced after administration of 18F-Fluciclovine

    Measured: 13 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2022
  2. Study start29 Nov 2026 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionSep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05555550
Sponsor's protocol ID
21-019390
Other IDs
21NO104
Status last verified
Sep 2026
First submitted
22 Sep 2022
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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 steps. Neuro Oncol. 2018 Jan 22;20(2):160-173. doi: 10.1093/neuonc/nox141.

    PubMed 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.

    PubMed 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 paediatric patients with BRAF-aberrant or neurofibromatosis type 1-associated recurrent, refractory, or progressive low-grade glioma: a multicentre, phase 2 trial. Lancet Oncol. 2019 Jul;20(7):1011-1022. doi: 10.1016/S1470-2045(19)30277-3. Epub 2019 May 28.

    PubMed 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.

    PubMed 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.

    PubMed 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 Winter;5(1):10-21. doi: 10.22038/aojnmb.2016.7869.

    PubMed 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.

    PubMed 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.

    PubMed 31418054

  • Tsuyuguchi N, Terakawa Y, Uda T, Nakajo K, Kanemura Y. Diagnosis of Brain Tumors Using Amino Acid Transport PET Imaging with 18F-fluciclovine: A Comparative Study with L-methyl-11C-methionine PET Imaging. Asia Ocean J Nucl Med Biol. 2017 Spring;5(2):85-94. doi: 10.22038/aojnmb.2017.8843.

    PubMed 28660218

  • Parent EE, Benayoun M, Ibeanu I, Olson JJ, Hadjipanayis CG, Brat DJ, Adhikarla V, Nye J, Schuster DM, Goodman MM. [18F]Fluciclovine PET discrimination between high- and low-grade gliomas. EJNMMI Res. 2018 Jul 25;8(1):67. doi: 10.1186/s13550-018-0415-3.

    PubMed 30046944

  • Kondo A, Ishii H, Aoki S, Suzuki M, Nagasawa H, Kubota K, Minamimoto R, Arakawa A, Tominaga M, Arai H. Phase IIa clinical study of [18F]fluciclovine: efficacy and safety of a new PET tracer for brain tumors. Ann Nucl Med. 2016 Nov;30(9):608-618. doi: 10.1007/s12149-016-1102-y. Epub 2016 Jul 14.

    PubMed 27418267

  • Liu CJ, Lu MY, Liu YL, Ko CL, Ko KY, Tzen KY, Chang HH, Yang YL, Jou ST, Hsu WM, Yen RF. Risk Stratification of Pediatric Patients With Neuroblastoma Using Volumetric Parameters of 18F-FDG and 18F-DOPA PET/CT. Clin Nucl Med. 2017 Mar;42(3):e142-e148. doi: 10.1097/RLU.0000000000001529.

    PubMed 28072621

  • Marner L, Nysom K, Sehested A, Borgwardt L, Mathiasen R, Henriksen OM, Lundemann M, Munck Af Rosenschold P, Thomsen C, Bogeskov L, Skjoth-Rasmussen J, Juhler M, Kruse A, Broholm H, Scheie D, Lauritsen T, Forman JL, Wehner PS, Hojgaard L, Law I. Early Postoperative 18F-FET PET/MRI for Pediatric Brain and Spinal Cord Tumors. J Nucl Med. 2019 Aug;60(8):1053-1058. doi: 10.2967/jnumed.118.220293. Epub 2019 Jan 25.

    PubMed 30683767

  • Morana G, Piccardo A, Puntoni M, Nozza P, Cama A, Raso A, Mascelli S, Massollo M, Milanaccio C, Garre ML, Rossi A. Diagnostic and prognostic value of 18F-DOPA PET and 1H-MR spectroscopy in pediatric supratentorial infiltrative gliomas: a comparative study. Neuro Oncol. 2015 Dec;17(12):1637-47. doi: 10.1093/neuonc/nov099. Epub 2015 Sep 23.

    PubMed 26405202

  • Albert NL, Weller M, Suchorska B, Galldiks N, Soffietti R, Kim MM, la Fougere C, Pope W, Law I, Arbizu J, Chamberlain MC, Vogelbaum M, Ellingson BM, Tonn JC. Response Assessment in Neuro-Oncology working group and European Association for Neuro-Oncology recommendations for the clinical use of PET imaging in gliomas. Neuro Oncol. 2016 Sep;18(9):1199-208. doi: 10.1093/neuonc/now058. Epub 2016 Apr 21.

    PubMed 27106405

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing 18F-Fluciclovine in people with Glioma and Low-grade Glioma, run by Children's Hospital of Philadelphia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mariam Aboian, MD, PhD (215-510-7661, aboianm@chop.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compare change in standardized uptake value parameters (SUVmax and SUVpeak) on metabolic tumor volume in 18F-Fluciclovine PET (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05555550, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.

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