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

Breast Cancer Clinical Trial

— FICTION  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04226222
• Other study ID #: ICO-2019-03
• Status: Active, not recruiting
• Start date: November 5, 2019
• Est. completion date: October 22, 2024

Study information

• Verified date: August 2022
• Source: Institut Cancerologie de l'Ouest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 132
• Est. completion date: October 22, 2024
• Est. primary completion date: October 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient with biopsy-proven triple-negative breast cancer, newly diagnosed, naïve from any treatment.

• Age - 18.

• Performance Status (PS) : 0 or 1.

• No metastasis on the extension balance.

• Treatment provided immediately by lumpectomy or mastectomy, and accepted by the patient.

Exclusion Criteria:

• Severe illness or comorbidity at risk.

• A history of cancer within 5 years, with the exception of skin carcinomas (other than melanoma) or in-situ cervical carcinomas.

• Patient candidate for neo-adjuvant therapy.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Diagnostic Test:
• TEP-TDM FDG
Semi-quantitative PET-TDM FDG Data and Texture Analysis

Locations

Country	Name	City	State
France	Institut de Cancérologie de l'Ouest	Angers
France	Institut de Cancerologie de L'Ouest	Saint-Herblain

Sponsors (1)

Lead Sponsor	Collaborator
Institut Cancerologie de l'Ouest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the prognostic value of the texture parameters of PET-TDM FDG on event-free survival at 2 years.	The 2-year event-free survival rate based on the texture parameters of the PET-TDM FDG.; Event free survival is the duration between the date of diagnosis and the date of the first event (relapse, death) or the date of the last news without event.	2 years
Secondary	assess the prognostic value of standard parameters (clinical, standard histology, conventional imaging), semi-quantitative PET-TDM FDG and innovative Immunohistochemistry parameters for 2-year event-free survival .	2-year event-free survival rate based on univariate analysis of standard, semi-quantitative parameters of PET-TDM FDG and innovative Immunohistochemistry parameters.	2 years
Secondary	To assess the correlations between continuous texture parameters in PET-TDM FDG and Immunohistochemistry.	Correlation coefficients between the continuous criteria of the FDG PET texture parameters and those of the Immunohistochemistry.	2 years
Secondary	assess the multivariate prognostic value of standard parameters, PET-TDM FDG imaging parameters and Immunohistochemistry defined as relevant to 2-year event-free survival	2-year event-free survival rate in multivariate analysis according to standard parameters, PET-TDM FDG imaging parameters and Immunohistochemistry.	2 years
Secondary	Construction of an optimal prognostic nomogram combining independent parameters to isolate different prognostic subgroups	2-year event-free survival rate depending on the risk groups determined from the nomogram score.	2 years