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

Primary Purpose

Glioma, Low-grade Glioma, Low Grade Glioma of Brain

Status

Not yet recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

18F-Fluciclovine

About this trial

This is an interventional diagnostic trial for Glioma focused on measuring Glioma, Low-grade Glioma, Low Grade Glioma of Brain, Glioma, Malignant, Glioma Intracranial, 18F-Fluciclovine

Eligibility Criteria

1 Year - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-Fluciclovine

Arm Description

18F-Fluciclovine PET-MRI

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT05555550

First Posted

September 22, 2022

Last Updated

August 30, 2023

Sponsor

Children's Hospital of Philadelphia

Collaborators

Blue Earth Diagnostics, Dragon Master Foundation

1. Study Identification

Unique Protocol Identification Number

NCT05555550

Brief Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 2023 (Anticipated)

Primary Completion Date

September 2025 (Anticipated)

Study Completion Date

September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Children's Hospital of Philadelphia

Collaborators

Blue Earth Diagnostics, Dragon Master Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioma, Low-grade Glioma, Low Grade Glioma of Brain, Glioma, Malignant, Glioma Intracranial

Keywords

Glioma, Low-grade Glioma, Low Grade Glioma of Brain, Glioma, Malignant, Glioma Intracranial, 18F-Fluciclovine

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

18F-Fluciclovine

Arm Type

Experimental

Arm Description

18F-Fluciclovine PET-MRI

Intervention Type

Drug

Intervention Name(s)

18F-Fluciclovine

Other Intervention Name(s)

Axumin

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

1 year

Title

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

Description

Calculate the change in tumor measurement on MRI

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Safety of 18F-Fluciclovine

Description

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

Time Frame

13 months

Other Pre-specified Outcome Measures:

Title

Response prediction

Description

Determine if Baseline PET uptake as predictors of treatment response

Time Frame

1 year

Title

Disease Progression

Description

Identify changes in PET metrics at the time of progression

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ali Nabavizadeh, MD

Phone

215-590-1000

nabavizadehs@chop.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Hannah Anderson

Phone

215-590-1000

hanna.anderson!@pennmedicine.upenn.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ali Nabavizadeh, MD

Organizational Affiliation

Children's Hospital of Philadelphia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's Hospital of Philadelphia

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ali Nabavizadeh, MD

nabavizadehs@chop.edu

cancertrials@chop.edu

12. IPD Sharing Statement

Plan to Share IPD

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

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