NCT04226222

Bringing of PET-TDM FDG in the Determination of the Characteristics of Primary Mammary Tumors TrIple Negatives

Bringing Semi-quantitative PET-TDM FDG Data and Texture Analysis to Clinical, Histological and Immuno-histochemical Characteristics of Primary Mammary Tumors Triple Negatives

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 132 (actual)
• Sponsor: Institut Cancerologie de l'Ouest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

"Triple Negative" breast cancers are a heterogeneous group characterized by the absence of hormone receptors to estrogen, progesterone and the absence of expression or amplification of the HER-2 gene. This type of cancer is associated with an adverse clinical profile with a high risk of early metastatic relapse. Accurate identification of prognostic factors, as well as predictors of therapeutic response, and the contribution of targeted therapies are avenues for improving the management and survival of patients with these cancers. Such an approach requires optimal biological characterization, allowing us to understand the complexity of this group of tumors, and requires multidisciplinary collaboration in clinical trials involving anatomopathology, oncology and morpho-functional imaging. The investigator's goal is to characterize by innovative methods (anatomo-pathological in particular Of Immunohistochemistry, and morpho-functional imaging (TEP-TDM FDG) semi-quantitative and texture) in a population of Triple Negative Breast Cancer scans better knowledge of this entity that can lead to the development of relevant therapeutic strategies and especially more adapted in the context of precision and personalized medicine.

Detailed description

120 consecutive patients with "Triple Negative" breast cancers operatable from the outset will be included in the study * To assess the prognostic value of the texture parameters of PET-TDM FDG on event-free survival at 2 years. * To assess the prognostic value of standard parameters (clinical, standard histology, conventional imaging), semi-quantitative PET-TDM FDG and innovative Immuno-histochemistry parameters for 2-year event-free survival . * To assess correlations between continuous PET-TDM FDG texture parameters and Immuno-histochemistry. * To assess the multivariate prognostic value of standard parameters, PET-TDM FDG imaging parameters and Immuno-histochemistry defined as relevant to 2-year event-free survival . * Construction of an optimal prognostic nomogram combining independent parameters to isolate different prognostic subgroups.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	TEP-TDM FDG	Semi-quantitative PET-TDM FDG Data and Texture Analysis

Timeline

• Start date: 2019-11-05
• Primary completion: 2022-10-22
• Completion: 2024-10-22
• First posted: 2020-01-13
• Last updated: 2023-02-21

Locations

2 sites across 1 country: France