GliomaPhase 3KINGNCT05512403
Evaluation of Diagnostic Performances of 18F-FDOPA PET KInetics
A Phase 3 study testing PET/CT with 18F-DOPA in people with Glioma, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
the investigators hypothesise that 18F-FDOPA PET kinetic parameters are good biomarkers to characterise suspected LGG brain lesions that exhibit no contrast on MRI, for identifying aggressive lesions. These parameters could constitute diagnostic biomarkers for this indication. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glioma
- What is being tested?
- PET/CT with 18F-DOPA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jun 2023to 30 Oct 2026
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years old
- WHO general condition ≤2
- Identification of a unifocal brain tumour at the initial diagnosis with no contrast in the MRI and suspected to be a LGG, with biopsy/surgery envisaged within 6 months of the PET scan
- MRI performed a maximum of 3 weeks before inclusion and comprising the conventional morphological sequences (T1, T1 sequences with injection of contrast agent and T2 FLAIR).
- Subject affiliated to or beneficiary of a social security plan
- Subject having received complete information on the organisation of the research and having signed the informed consent form.
Who cannot join
- Multifocal brain lesions
- Contraindication to 18F-FDOPA PET
- Pregnant, parturient women or nursing mothers under Article L1121-5
- Women of childbearing age who do not have effective contraception under Article L1121-5
- Monitoring not possible
- Persons deprived of their liberty by a judicial or administrative decision under Article 1121-8, persons undergoing psychiatric treatment under Articles L. 3212-1 and L. 3213-1.
- Patients cannot simultaneously participate in an interventional research trial for the duration of the KING study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU Nancy
Vandœuvre-lès-Nancy, 54511
VERONIQUE ROCH, MSc, v.roch@chru-nancy.fr
About this study
Official title: Evaluation of Diagnostic Performances of 18F-FDOPA PET KInetics as Biomarkers for the Improvement of Care of MRI Non-contrast Enhanced Gliomas
the investigators hypothesise that 18F-FDOPA PET kinetic parameters are good biomarkers to characterise suspected LGG brain lesions that exhibit no contrast on MRI, for identifying aggressive lesions. These parameters could constitute diagnostic biomarkers for this indication. This new diagnostic tool could enhance patient care in the short term in an evolving pathology affecting socially active subjects with a poor prognosis
Read the detailed description
Diffuse low-grade gliomas (LGGs) without any contrast enhancement on MRI are rare (15% of gliomas, 700 cases/year in France), have a poor prognosis (median overall survival from 5 to 15 years) and affect young, socially active subjects (median age 40 years). Among these lesions, 30% present with high grade histopathological criteria or with poor prognostic molecular characteristics, according to the 2021 WHO Classification of Tumors of the Central Nervous System (lack of IDH [Isocitrate DeHydrogenase] mutation, CDKN2A/B deletion). These high-grade types of tumours progress within 6 months and their diagnosis and management represent a public health issue. Moreover, the care of LGG patients is currently not standardised.
Although treatment is based on surgery and the complete excision of the lesion, as far as this is possible, and/or first-line chemotherapy ±radiotherapy, the optimal time to begin treatment remains controversial.
Aggressive forms should be diagnosed as soon as possible to allow immediate surgery to improve survival, whilst strategies allowing the maintenance of an optimal quality of life, more often with functional surgery alone, are recommended for non-aggressive forms. The main hurdle to standardised patient management is the lack of amenable non-invasive biomarkers to identify aggressive LGG forms.
18F-FDOPA positron emission tomography (PET) is promising to diagnose initial gliomas with conventional Standardised-Uptake-Value (SUV) parameters. Our team recently demonstrated the potential of 18F-FDOPA PET kinetics to better characterise gliomas. Two parameters are determined from the 30-minute dynamic acquisition curve of the tumour: the time-to-peak SUV (TTP), and the SUV slope. In our previous studies, limited by their monocentric and retrospective nature, molecular characteristics were mainly predicted by TTP: long TTP for an IDH-mutation and short TTP for IDH-wildtype tumours. A prospective multicentric study is needed to confirm our preliminary results in a specific population of suspected LGGs without any contrast enhancement on MRI.
The investigator hypothesise that 18F-FDOPA PET kinetic parameters are biomarkers which lead to improved care because they characterise aggressive forms of gliomas exhibiting no contrast on MRI.
- Conditions
- Glioma
- Being tested
- PET/CT with 18F-DOPA
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CT with 18F-DOPADrug
A 18F-FDOPA PET exam is then performed (acquisition of 30 minutes in List Mode format) according to the French guidelines for PET neuro-oncological indications (Verger et al. Med Nuc, 2020, (5)).
Patient preparation and acquisition:
- 4 hours of fasting
- No carbidopa premedication
- 2 MBq / kg of 18F-FDOPA
- Dynamic acquisition in List Mode format for 30 min starting simultaneously with the patient's injection
- Low dose scanner for attenuation correction
| Study group | Role | What they receive |
|---|---|---|
| Patients with Low Grade Glioma (LGG) without any MRI contrast enhancement | Experimental | Patients presenting with brain lesions that lack contrast enhancement on MRI, that are suspected to be LGGs and that are referred for biopsy or surgery within the following 6 months will be eligible for the study. The initial MRI should be performed a maximum of 3 weeks before patient inclusion and should at least include the conventional morphological sequences (T1, T1 sequences with injection of contrast product and T2 FLAIR).
Patients will be selected in a neuro-oncological multidisciplinary consultation meeting. Receives: Drug: PET/CT with 18F-DOPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess diagnostic performances of 18F-FDOPA PET (Positon Emission Tomography) Time-To-Peak in suspected LGGs without MRI -contrast enhancement for characterisation of aggressive lesions
the sensitivity, specificity, predictive positive value (PPV) and negative predictive value (NPV) of the 18F-FDOPA kinetic TTP parameter, to characterise aggressive lesions within suspected LGGs with no contrast enhancement on MRI at the initial diagnosis.
Measured: 24 months
Secondary outcomes (4)
To assess the diagnostic performances of 18F-FDOPA "slope", to characterise aggressive lesions
Sensitivity, specificity, Positive Predictive Value and Negative Predicitive Value of the 18F-FDOPA kinetic "slope" parameter
Measured: 24 months
To assess the diagnostic performances of 18F-FDOPA SUV static conventional parameters and/or radiomics analyses associated with TTP kinetic parameter, to characterise aggressive lesions
Sensitivity, specificity, positive predictive and negative predictive values of the 18F-FDOPA conventional parameters and/or radiomics analysis and the kinetic parameter.
Measured: 24 months
To assess, in patients suspected to have a non-contrast enhanced glioma at diagnosis the prevalence of aggressive forms within the suspected LGGs without any MRI contrast
Proportion of aggressive lesions expressed as an instantaneous prevalence and its 95% confidence interval of the total number of suspected LGGs without any contrast enhancement on MRI examined at initial diagnosis and referred for biopsy or surgery within the following 6 months.
enhancement
Measured: 24 months
To assess, in patients suspected to have a non-contrast enhanced glioma at diagnosis the clinical impact of the 18F-FDOPA PET (positon emission tomography) Time-To-Peak parameter
Number of patients who need to be diagnosed with 18F-FDOPA kinetic parameter TTP to identify an aggressive lesion within the suspected LGG population that do not exhibit any contrast enhancement on MRI at initial diagnosis and that undergo biopsy/surgery, defined as: 1/ [% of aggressive lesions detected with the 18F-FDOPA Time-To-Peak parameter].
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start13 Jun 2023
- Primary completion12 Dec 2025 (estimated)
- Study completion30 Oct 2026 (estimated)
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.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients presenting with brain lesions that lack contrast enhancement on MRI, that are suspected to be LGGs and that are referred for biopsy or surgery within the following 6 months will be eligible for the study.
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antoine VERGER, Central Hospital, Nancy, France
- Investigators
- Antoine VERGER, MD, PhD, Principal investigator, CHRU NancyAurélie KAS, MD, PhD, Principal investigator, APHP salpêtrière PARISEric GUEDJ, MD,PhD, Principal investigator, APHM MarseilleCaroline BUND, MD, Principal investigator, Institut de cancérologie Strasbourg EuropeFlorence LEJEUNE, MD, PhD, Principal investigator, Eugène MARQUIS NantesAnthelme FLAUS, MD, Principal investigator, Hospices Civils de LyonNicolas De LEIRIS, MD, Principal investigator, University Hospital, GrenobleSolène QUERELLOU, MD, Principal investigator, CHRU de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05512403
- Sponsor's protocol ID
- 2020PI126
- Acronym
- KING
- Status last verified
- Sep 2024
- First submitted
- 22 Aug 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Diagnostic Performances of 18F-FDOPA PET KInetics as Biomarkers for the Improvement of Care of MRI Non-contrast Enhanced Gliomas
- ClinicalTrials.gov ID
- NCT05512403
- Acronym / sponsor ID
- KING / 2020PI126
- Conditions
- Glioma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 13 Jun 2023 (actual)
- Primary completion
- 12 Dec 2025 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 23 Aug 2022 (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 investigators hypothesise that 18F-FDOPA PET kinetic parameters are good biomarkers to characterise suspected LGG brain lesions that exhibit no contrast on MRI, for identifying aggressive lesions. These parameters could constitute diagnostic biomarkers for this indication. This new diagnostic tool could enhance patient care in the short term in an evolving pathology affecting socially active subjects with a poor prognosis
Detailed description
Diffuse low-grade gliomas (LGGs) without any contrast enhancement on MRI are rare (15% of gliomas, 700 cases/year in France), have a poor prognosis (median overall survival from 5 to 15 years) and affect young, socially active subjects (median age 40 years). Among these lesions, 30% present with high grade histopathological criteria or with poor prognostic molecular characteristics, according to the 2021 WHO Classification of Tumors of the Central Nervous System (lack of IDH [Isocitrate DeHydrogenase] mutation, CDKN2A/B deletion). These high-grade types of tumours progress within 6 months and their diagnosis and management represent a public health issue. Moreover, the care of LGG patients is currently not standardised.
Although treatment is based on surgery and the complete excision of the lesion, as far as this is possible, and/or first-line chemotherapy ±radiotherapy, the optimal time to begin treatment remains controversial.
Aggressive forms should be diagnosed as soon as possible to allow immediate surgery to improve survival, whilst strategies allowing the maintenance of an optimal quality of life, more often with functional surgery alone, are recommended for non-aggressive forms. The main hurdle to standardised patient management is the lack of amenable non-invasive biomarkers to identify aggressive LGG forms.
18F-FDOPA positron emission tomography (PET) is promising to diagnose initial gliomas with conventional Standardised-Uptake-Value (SUV) parameters. Our team recently demonstrated the potential of 18F-FDOPA PET kinetics to better characterise gliomas. Two parameters are determined from the 30-minute dynamic acquisition curve of the tumour: the time-to-peak SUV (TTP), and the SUV slope. In our previous studies, limited by their monocentric and retrospective nature, molecular characteristics were mainly predicted by TTP: long TTP for an IDH-mutation and short TTP for IDH-wildtype tumours. A prospective multicentric study is needed to confirm our preliminary results in a specific population of suspected LGGs without any contrast enhancement on MRI.
The investigator hypothesise that 18F-FDOPA PET kinetic parameters are biomarkers which lead to improved care because they characterise aggressive forms of gliomas exhibiting no contrast on MRI.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients presenting with brain lesions that lack contrast enhancement on MRI, that are suspected to be LGGs and that are referred for biopsy or surgery within the following 6 months will be eligible for the study.
| Arm | Type | Receives |
|---|---|---|
| Patients with Low Grade Glioma (LGG) without any MRI contrast enhancement | Experimental | Drug: PET/CT with 18F-DOPAPatients presenting with brain lesions that lack contrast enhancement on MRI, that are suspected to be LGGs and that are referred for biopsy or surgery within the following 6 months will be eligible for the study. The initial MRI should be performed a maximum of 3 weeks before patient inclusion and should at least include the conventional morphological sequences (T1, T1 sequences with injection of contrast product and T2 FLAIR). Patients will be selected in a neuro-oncological multidisciplinary consultation meeting. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 75 years old
- WHO general condition ≤2
- Identification of a unifocal brain tumour at the initial diagnosis with no contrast in the MRI and suspected to be a LGG, with biopsy/surgery envisaged within 6 months of the PET scan
- MRI performed a maximum of 3 weeks before inclusion and comprising the conventional morphological sequences (T1, T1 sequences with injection of contrast agent and T2 FLAIR).
- Subject affiliated to or beneficiary of a social security plan
Key exclusion criteria (7 listed)
- Multifocal brain lesions
- Contraindication to 18F-FDOPA PET
- Pregnant, parturient women or nursing mothers under Article L1121-5
- Women of childbearing age who do not have effective contraception under Article L1121-5
- Monitoring not possible
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 |
|---|---|---|
| PET/CT with 18F-DOPAA 18F-FDOPA PET exam is then performed (acquisition of 30 minutes in List Mode format) according to the French guidelines for PET neuro-oncological indications (Verger et al. Med Nuc, 2020, (5)). Patient preparation and acquisition: * 4 hours of fasting * No carbidopa premedication * 2 MBq / kg of 18F-FDOPA * Dynamic acquisition in List Mode format for 30 min starting simultaneously with the patient's injection * Low dose scanner for attenuation correction | Drug | Patients with Low Grade Glioma (LGG) without any MRI contrast enhancement |
Primary outcome
To assess diagnostic performances of 18F-FDOPA PET (Positon Emission Tomography) Time-To-Peak in suspected LGGs without MRI -contrast enhancement for characterisation of aggressive lesions
Time frame: 24 months
the sensitivity, specificity, predictive positive value (PPV) and negative predictive value (NPV) of the 18F-FDOPA kinetic TTP parameter, to characterise aggressive lesions within suspected LGGs with no contrast enhancement on MRI at the initial diagnosis.
4 secondary outcomes
To assess the diagnostic performances of 18F-FDOPA "slope", to characterise aggressive lesions
Time frame: 24 months
To assess the diagnostic performances of 18F-FDOPA SUV static conventional parameters and/or radiomics analyses associated with TTP kinetic parameter, to characterise aggressive lesions
Time frame: 24 months
To assess, in patients suspected to have a non-contrast enhanced glioma at diagnosis the prevalence of aggressive forms within the suspected LGGs without any MRI contrast
Time frame: 24 months
To assess, in patients suspected to have a non-contrast enhanced glioma at diagnosis the clinical impact of the 18F-FDOPA PET (positon emission tomography) Time-To-Peak parameter
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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.
Antoine VERGER, MD, PhD principal investigator
CHRU Nancy
Aurélie KAS, MD, PhD principal investigator
APHP salpêtrière PARIS
Eric GUEDJ, MD,PhD principal investigator
APHM Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PET/CT with 18F-DOPA in people with Glioma, run by Central Hospital, Nancy, France at 1 site in France.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact VERONIQUE ROCH, MSc (0383154276 ext. +33, v.roch@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess diagnostic performances of 18F-FDOPA PET (Positon Emission Tomography) Time-To-Peak in suspected LGGs without MRI -contrast enhancement for characterisation of aggressive lesions (time frame: 24 months). 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 19 Sep 2024.