SYF553de746aeff406198b385424602bac4Registry ID: 2024-515850-26-00|UnknownPhase 2
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interventional
N/A
1 country
4
To define the sensitivity of PET-DOPA for the detection of newly diagnosed untreated brain metastases (breast, lung, melanoma) on MRI measuring at least 5 mm in diameter
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June 27, 2024
Actual (reported)number of metastases detected on PET-DOPA compared to the number of metastases + 5 mm detected on MRI
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
Institut De Cancerologie De L Ouest
Saint-Herblain Cedex, 44805, France
Institut De Cancerologie De L Ouest
Angers, 49100, France
Hopital NOVO
Pontoise, 95300, France
TIGREAT Marine
First Submitted
June 27, 2024
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Centre Hospitalier Universitaire D'Angers
Angers, 49100, France