PET-DOPA Metabolic Detection and Characterization of Untreated Brain Metastases of Bronchial, Breast and Melanoma Cancer (DOPACER)

Conditions

breast cancer or melanoma) measuring more than 5 mm and explored on MRI, patients with newly discovered brain metastases (non-small cell lung cancer

Brief summary

number of metastases detected on PET-DOPA compared to the number of metastases + 5 mm detected on MRI

Detailed description

a) The sensitivity of DOPA-PET is defined above (primary endpoint). Site-specific sensitivity will be calculated for 8 primary tumor categories: 3 for lung cancer (EGFR mutation or ALK rearrangement; PDL1+; others), 2 for melanoma (BRAF V600 mutation; others), 3 for breast cancer (triple negative; Her2+ RH-; others), b) Lesion characterization will be defined by SUVmax, SUVmean, tumor/brain background fixation ratio, tumor/striatum fixation ratio., c) Dynamic images are described with the analysis of activity-time curves (time to peak, slope of the curve from the 10th minute)., d) The 8 categories mentioned above will be considered for the classification of the operated MC

Related papers

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Interventions

DRUGDopacis 90 MBq/ml oplossing voor injectie

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
number of metastases detected on PET-DOPA compared to the number of metastases + 5 mm detected on MRI	—

Secondary

Measure	Time frame
a) The sensitivity of DOPA-PET is defined above (primary endpoint). Site-specific sensitivity will be calculated for 8 primary tumor categories: 3 for lung cancer (EGFR mutation or ALK rearrangement; PDL1+; others), 2 for melanoma (BRAF V600 mutation; others), 3 for breast cancer (triple negative; Her2+ RH-; others), b) Lesion characterization will be defined by SUVmax, SUVmean, tumor/brain background fixation ratio, tumor/striatum fixation ratio., c) Dynamic images are described with the analysis of activity-time curves (time to peak, slope of the curve from the 10th minute)., d) The 8 categories mentioned above will be considered for the classification of the operated MC	—

Measure

Time frame

a) The sensitivity of DOPA-PET is defined above (primary endpoint). Site-specific sensitivity will be calculated for 8 primary tumor categories: 3 for lung cancer (EGFR mutation or ALK rearrangement; PDL1+; others), 2 for melanoma (BRAF V600 mutation; others), 3 for breast cancer (triple negative; Her2+ RH-; others), b) Lesion characterization will be defined by SUVmax, SUVmean, tumor/brain background fixation ratio, tumor/striatum fixation ratio., c) Dynamic images are described with the analysis of activity-time curves (time to peak, slope of the curve from the 10th minute)., d) The 8 categories mentioned above will be considered for the classification of the operated MC

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Countries

France

Outcome results

None listed