Evaluation of diagnostic performances of 18F-FDOPA PET KInetics as biomarkers for the improvement of care of MRI Non-contrast enhanced Gliomas : a phase IIIb exploratory trial

Conditions

Low Grade Glioma

Brief summary

The primary endpoints are: 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.

Detailed description

Sensitivity, specificity, PPV and NPV of the 18F-FDOPA kinetic “slope” parameter., Sensitivity, specificity, PPV and NPV of the 18F-FDOPA SUV conventional parameters (SUVmax, SUVmean and SUVpeak) and/or radiomics analysis (with the best predictive radiomics model) associated to the TTP kinetic parameter., 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, 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 TTP parameter].

Related papers

No related papers found yet.

Interventions

DRUGDopacis 90 MBq/mL

DRUGsolution injectable

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoints are: 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.	—

Secondary

Measure	Time frame
Sensitivity, specificity, PPV and NPV of the 18F-FDOPA kinetic “slope” parameter., Sensitivity, specificity, PPV and NPV of the 18F-FDOPA SUV conventional parameters (SUVmax, SUVmean and SUVpeak) and/or radiomics analysis (with the best predictive radiomics model) associated to the TTP kinetic parameter., 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, 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 TTP parameter].	—

Measure

Time frame

Sensitivity, specificity, PPV and NPV of the 18F-FDOPA kinetic “slope” parameter., Sensitivity, specificity, PPV and NPV of the 18F-FDOPA SUV conventional parameters (SUVmax, SUVmean and SUVpeak) and/or radiomics analysis (with the best predictive radiomics model) associated to the TTP kinetic parameter., 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, 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 TTP parameter].

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Countries

France

Outcome results

None listed