patients with newly discovered brain metastases (non-small cell lung cancer, breast cancer or melanoma) measuring more than 5 mm and explored on MRI MedDRA version: 20.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10059515 Term: Non-small cell lung cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malig
Conditions
Interventions
Trade Name: fluorodopa (18F) (F-DOPA)
Product Name: F-DOPA
Pharmaceutical Form: Solution for injection
Sponsors
INSTITUT DE CANCEROLOGIE DE L'OUEST
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven primary cancer (non-small cell lung, breast or melanoma) 2) Presence of brain metastasis(s) visualized on MRI, with at least 1 measuring more than 5 mm 3) Age = 18 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 26 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 26
Exclusion criteria
Exclusion criteria: 1) History of cerebral irradiation 2) Previous brain surgery for brain metastasis or glial tumor 3) Systemic therapy (chemotherapy, targeted therapy, immunotherapy) modified in the 6 weeks preceding the PET-DOPA scan, 4) New anti-tumor treatment (excluding corticosteroids) started between the discovery of CD and the performance of the PET-DOPA scan 5) Other concomitant cancer, or history of cancer in the 5 years preceding the patient's inclusion in the protocol other than basal or squamous cell carcinoma 6) Pregnant, likely to be pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: a) Define the sensitivity of DOPA-PET according to the site of the primary tumor (lung, breast, melanoma) and its characteristics b) Characterize DOPA+ lesions in 20 and 30 minutes summed images analysis (SUVmax, SUVmean, tumor/brain background fixation ratio, tumor/striatum fixation ratio) c) Characterize DOPA+ lesions by dynamic image analysis (activity-time curves) d) For lesions operated within 2 months after the realization of the PET-DOPA, to evaluate the correlation between the various parameters of characterization of the F-DOPA fixation and the characteristics of the MC;Primary end point(s): number of metastases detected on PET-DOPA compared to the number of metastases + 5 mm detected on MRI;Timepoint(s) of evaluation of this end point: 1 day | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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.;Timepoint(s) of evaluation of this end point: 2 months | — |
Countries
France
Contacts
Public ContactClinical Researc Dpt - Promotion
INSTITUT DE CANCEROLOGIE DE L'OUEST
Outcome results
None listed