PET-DOPA Metabolic Detection and Characterization of Untreated Brain Metastases of Bronchial, Breast and Melanoma Cancer
- Conditions
- patients with newly discovered brain metastases (non-small cell lung cancer, breast cancer or melanoma) measuring more than 5 mm and explored on MRIMedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10027480Term: Metastatic malignant melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2021-001017-37-FR
- Lead Sponsor
- INSTITUT DE CANCEROLOGIE DE L'OUEST
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 52
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>b) Characterize DOPA+ lesions in 20 and 30 minutes summed images analysis (SUVmax, SUVmean, tumor/brain background fixation ratio, tumor/striatum fixation ratio)<br>c) Characterize DOPA+ lesions by dynamic image analysis (activity-time curves)<br>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 Outcome Measures
Name Time Method 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) <br>b) Lesion characterization will be defined by SUVmax, SUVmean, tumor/brain background fixation ratio, tumor/striatum fixation ratio. <br>c) Dynamic images are described with the analysis of activity-time curves (time to peak, slope of the curve from the 10th minute). <br>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