Clincosm LogoSign in Get a demo

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

Sponsor
Children's Hospital of Philadelphia (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05555550
Collaborator
Blue Earth Diagnostics, Inc (Other), Dragon Master Foundation (Other)
30
Enrollment
1
Location
1
Arm
47
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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. Changes in 18F-Fluciclovine uptake will be compared to changes in MRI measurements at 3 months and 1 year as compared to baseline.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Evaluation of 18F-Fluciclovine PET-MRI as a Biomarker of Response in Pediatric and Young Adult Patients With Low Grade Gliomas (LGG)
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2025
Anticipated Study Completion Date :
Sep 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: 18F-Fluciclovine

18F-Fluciclovine PET-MRI

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

    		•

    Outcome Measures

    Primary Outcome Measures

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

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

    2. Compare changes in pretreatment tumor measurement on MRI in pediatric participants who initiate systemic treatment for LGG [1 year]

      Calculate the change in tumor measurement on MRI

    Secondary Outcome Measures

    1. Safety of 18F-Fluciclovine [13 months]

      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

    Other Outcome Measures

    1. Response prediction [1 year]

      Determine if Baseline PET uptake as predictors of treatment response

    2. Disease Progression [1 year]

      Identify changes in PET metrics at the time of progression

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 21 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • LGG (WHO grade I-II), confirmed by biopsy unless in Neurofibromatosis type 1 (NF1) participants with classic appearance

    • Participants must have evaluable disease (1x1 cm tumor on MRI; enhancing + non-enhancing tumor)

    • Scheduled to receive systemic therapy

    • 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 between ≥ 1 years but ≤21 years at time of study registration

    Exclusion Criteria:

    • Inability to tolerate imaging procedures in the opinion of an investigator or treating physician

    • Pregnant participants

    • Patient who would require sedation or anesthesia for imaging beyond standard of care (SOC).

    • 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 above expected values for age and gender.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104

    Sponsors and Collaborators

    • Children's Hospital of Philadelphia
    • Blue Earth Diagnostics, Inc
    • Dragon Master Foundation

    Investigators

    • Principal Investigator: Ali Nabavizadeh, MD, Children's Hospital of Philadelphia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Children's Hospital of Philadelphia
    ClinicalTrials.gov Identifier:
    NCT05555550
    Other Study ID Numbers:
    • 21-019390
    • 21NO104
    First Posted:
    Sep 27, 2022
    Last Update Posted:
    Oct 4, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Children's Hospital of Philadelphia
    Glioma
    Low-grade Glioma
    Low Grade Glioma of Brain
    Glioma, Malignant
    Glioma Intracranial
    18F-Fluciclovine
    Additional relevant MeSH terms:
    Glioma

    Study Results

    No Results Posted as of Oct 4, 2022