GliomaINFLAGLINCT05672082
Contribution of [18F]DPA-714 PET for Grading and Exploration of the Inflammatory Microenvironment of Glioma.
A study testing [18F]DPA-714 in people with Glioma, run by Center Eugene Marquis.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma
- What is being tested?
- [18F]DPA-714
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Contribution of [18F]DPA-714 PET for Grading and Exploration of the Inflammatory Microenvironment of Glioma, a Pilot Study
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.
- Conditions
- Glioma
- Being tested
- [18F]DPA-714
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]DPA-714Drug
Participant received one injection of 200 MBq of [18F]DPA-714
| Study group | Role | What they receive |
|---|---|---|
| [18F]DPA-714 PET | Experimental | Not described Receives: Drug: [18F]DPA-714 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: [18F]DPA-714 PET performed up to 30 days before brain surgery
Secondary outcomes (2)
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
Measured: [18F]DPA-714 PET performed up to 30 days before brain surgery
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
Measured: [18F]DPA-714 PET performed up to 30 days before brain surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Why it stopped: Organisational difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center Eugene Marquis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier PALARD NOVELLO, Dr, Principal investigator, Centre de lutte contre le cancer Eugène Marquis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05672082
- Sponsor's protocol ID
- 2022-1-58-002
- Acronym
- INFLAGLI
- Status last verified
- Feb 2024
- First submitted
- 3 Jan 2023
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of [18F]DPA-714 PET for Grading and Exploration of the Inflammatory Microenvironment of Glioma, a Pilot Study
- ClinicalTrials.gov ID
- NCT05672082
- Acronym / sponsor ID
- INFLAGLI / 2022-1-58-002
- Conditions
- Glioma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Organisational difficulties
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Center Eugene MarquisUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 5 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18F]DPA-714 PET | Experimental | Drug: [18F]DPA-714 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]DPA-714Participant received one injection of 200 MBq of [18F]DPA-714 | Drug | [18F]DPA-714 PET |
Primary outcome
Diagnostic performances of [18F]DPA-714 PET for glioma grading obtained by stereotactic biopsies of glioma
Time frame: [18F]DPA-714 PET performed up to 30 days before brain surgery
Sensitivity and specificity of [18F]DPA-714 PET using anatomopathological assessment of biopsies as gold standard
2 secondary outcomes
Comparison of [18F]DPA-714 PET quantitative parameters with anatomopathological assessment of the surgery specimen
Time frame: [18F]DPA-714 PET performed up to 30 days before brain surgery
Comparison of [18F]DPA-714 PET quantitative parameters with tumor microenvironment
Time frame: [18F]DPA-714 PET performed up to 30 days before brain surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier PALARD NOVELLO, Dr principal investigator
Centre de lutte contre le cancer Eugène Marquis
Questions about this trial
What is this clinical trial studying?
A study testing [18F]DPA-714 in people with Glioma, run by Center Eugene Marquis.
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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performances of [18F]DPA-714 PET for glioma grading obtained by stereotactic biopsies of glioma (time frame: [18F]DPA-714 PET performed up to 30 days before brain surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2024.