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Contribution of [18F]DPA-714 PET for Grading and Exploration of the Inflammatory Microenvironment of Glioma. (INFLAGLI)

Primary Purpose

Glioma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
[18F]DPA-714
Sponsored by
Center Eugene Marquis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age greater than or equal to 18 years Suspicion of an operable diffuse glioma Written informed consent (signed) Affiliated or beneficiary of a social security plan Exclusion Criteria: Suspicion of grade I glioma Surgical urgency (less than 8 days between the suspected diagnosis and surgery) Pregnant or breastfeeding woman Persons deprived of liberty or under guardianship Impossibility to undergo the medical follow-up of the trial for geographical, social or psychological reasons

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    [18F]DPA-714 PET

    Arm Description

    Outcomes

    Primary Outcome Measures

    Diagnostic performances of [18F]DPA-714 PET for glioma grading obtained by stereotactic biopsies of glioma
    Sensitivity and specificity of [18F]DPA-714 PET using anatomopathological assessment of biopsies as gold standard

    Secondary Outcome Measures

    Comparison of [18F]DPA-714 PET quantitative parameters with anatomopathological assessment of the surgery specimen
    Comparison of [18F]DPA-714 PET quantitative parameters with the histological types of gliomas, with the IDH1-mutational status, and the 1p19q codeletion status
    Comparison of [18F]DPA-714 PET quantitative parameters with tumor microenvironment
    Comparison of [18F]DPA-714 PET quantitative parameters with the frequency and phenotype of tumor microenvironment different glioma-associated cells

    Full Information

    First Posted
    January 3, 2023
    Last Updated
    July 4, 2023
    Sponsor
    Center Eugene Marquis
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05672082
    Brief Title
    Contribution of [18F]DPA-714 PET for Grading and Exploration of the Inflammatory Microenvironment of Glioma.
    Acronym
    INFLAGLI
    Official Title
    Contribution of [18F]DPA-714 PET for Grading and Exploration of the Inflammatory Microenvironment of Glioma, a Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    March 1, 2025 (Anticipated)
    Study Completion Date
    April 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Center Eugene Marquis

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The 18-kDa translocator protein (TSPO) is a mitochondrial protein that is weakly expressed in the healthy brain. However, there is an increase in the expression of TSPO in glial tumors. It is even associated with a higher malignancy and a shorter survival of patients. Among the different TSPO ligands, the most commonly used tracers in PET imaging are [18F]DPA-714 and 18F-GE180. We hypothesize that [18F]DPA-714 PET could improve the current performance for tumor grade definition in vivo, which is a major issue for the therapeutic management of gliomas.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    [18F]DPA-714 PET
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    [18F]DPA-714
    Intervention Description
    Participant received one injection of 200 MBq of [18F]DPA-714
    Primary Outcome Measure Information:
    Title
    Diagnostic performances of [18F]DPA-714 PET for glioma grading obtained by stereotactic biopsies of glioma
    Description
    Sensitivity and specificity of [18F]DPA-714 PET using anatomopathological assessment of biopsies as gold standard
    Time Frame
    [18F]DPA-714 PET performed up to 30 days before brain surgery
    Secondary Outcome Measure Information:
    Title
    Comparison of [18F]DPA-714 PET quantitative parameters with anatomopathological assessment of the surgery specimen
    Description
    Comparison of [18F]DPA-714 PET quantitative parameters with the histological types of gliomas, with the IDH1-mutational status, and the 1p19q codeletion status
    Time Frame
    [18F]DPA-714 PET performed up to 30 days before brain surgery
    Title
    Comparison of [18F]DPA-714 PET quantitative parameters with tumor microenvironment
    Description
    Comparison of [18F]DPA-714 PET quantitative parameters with the frequency and phenotype of tumor microenvironment different glioma-associated cells
    Time Frame
    [18F]DPA-714 PET performed up to 30 days before brain surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age greater than or equal to 18 years Suspicion of an operable diffuse glioma Written informed consent (signed) Affiliated or beneficiary of a social security plan Exclusion Criteria: Suspicion of grade I glioma Surgical urgency (less than 8 days between the suspected diagnosis and surgery) Pregnant or breastfeeding woman Persons deprived of liberty or under guardianship Impossibility to undergo the medical follow-up of the trial for geographical, social or psychological reasons
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xavier PALARD NOVELLO, Dr
    Phone
    299253000
    Ext
    +33
    Email
    x.palard@rennes.unicencer.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Valérie JOLAINE
    Phone
    299253036
    Ext
    +33
    Email
    v.jolaine@rennes.unicancer.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xavier PALARD NOVELLO, Dr
    Organizational Affiliation
    Centre de lutte contre le cancer Eugène Marquis
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Contribution of [18F]DPA-714 PET for Grading and Exploration of the Inflammatory Microenvironment of Glioma.

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