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18F-Fluciclovine PET-MRI in High-grade Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05553041
Recruitment Status : Not yet recruiting
First Posted : September 23, 2022
Last Update Posted : September 23, 2022
Sponsor:
Collaborators:
Blue Earth Diagnostics, Inc
Dragon Master Foundation
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Glioma High Grade Glioma Glioma, Malignant Glioma Intracranial Diffuse Glioma Drug: 18F-Fluciclovine PET-MRI Early Phase 1

Detailed Description:

Following radiation and immunotherapy, many pediatric participants with high-grade gliomas (HGG), including diffuse midline glioma (DMG), demonstrate radiographic findings suspicious of disease progression. Differentiating post-treatment changes from true tumor progression is paramount to clinical decision-making, as true tumor progression may warrant a change in treatment, while post-treatment changes are typically not an indication to change treatment. Unfortunately, conventional MRI cannot reliably distinguish between true progression and post-treatment changes. Therefore, finding a physiological correlate to delineate true progression from pseudo-progression is critical.

The overall objective of this current application is to evaluate 18F-fluciclovine PET imaging as a diagnostic biomarker for tumor progression compared to post-treatment changes in pediatric HGG. The long-term goal of this research is to accurately differentiate tumor progression from post-treatment changes in pediatric HGG using 18F-fluciclovine PET imaging.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 to Differentiate Tumor Progression From Post-treatment Changes in Pediatric High-grade Glioma (HGG)
Estimated Study Start Date : October 2022
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : October 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 18F-Fluciclovine PET-MRI in pediatric HGG or DMG participants
Single intravenous administration of 18F fluciclovine for PET-MRI Scan
Drug: 18F-Fluciclovine PET-MRI
18F-Fluciclovine will be injected via IV prior to Positron emission tomography (PET)-Magnetic resonance imaging (MRI)
Other Name: Axumin




Primary Outcome Measures :
  1. Image analysis [ Time Frame: 6 months ]
    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.

  2. Histopathology analysis [ Time Frame: 4 weeks ]
    Evaluation of SUV uptake post radiation in participants with planned biopsy or resection who experience true progression versus those who experience pseudoprogression as confirmed by histopathology.


Secondary Outcome Measures :
  1. Safety of 18F-Fluciclovine [ Time Frame: 6 months ]
    The Safety profile of 18F-Fluciclovine PET in pediatric HGG participants will be assessed based on CTCAE 5.0 toxicity experienced after administration of 18F-Fluciclovine



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 above expected values for age and gender.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05553041


Contacts
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Contact: Ali Nabavizadeh 215-590-1000 nabavizadehs@chop.edu
Contact: Hannah Anderson 215-590-1000 hannah.anderson@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Contact: Ali Nabavizadeh, MD       nabavizadehs@chop.edu   
Contact: Hannah Anderson    215-590-1000    hannah.anderson@pennmedicine.upenn.edu   
Sponsors and Collaborators
Children's Hospital of Philadelphia
Blue Earth Diagnostics, Inc
Dragon Master Foundation
Investigators
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Principal Investigator: Ali Nabavizadeh, MD Children's Hospital of Philadelphia
Publications:

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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT05553041    
Other Study ID Numbers: 21-019514
First Posted: September 23, 2022    Key Record Dates
Last Update Posted: September 23, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
High Grade Glioma
Glioma, Malignant
Glioma Intracranial
Diffuse Glioma
18F fluciclovine
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue