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

February 20, 2023 updated by: Institut Cancerologie de l'Ouest

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

"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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

132

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49055
        • Institut de Cancérologie de l'Ouest
      • Saint-Herblain, France, 44805
        • Institut de Cancérologie de l'Ouest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with triple negative breast cancer operatable from the outset will be

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Triple negative Breast Cancer
Triple Negative Breast Cancer operatable from the outset
Diagnostic test: TEP-TDM FDG
Semi-quantitative PET-TDM FDG Data and Texture Analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the prognostic value of the texture parameters of PET-TDM FDG on event-free survival at 2 years.
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 .
Time Frame: 2 years
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
To assess the correlations between continuous texture parameters in PET-TDM FDG and Immunohistochemistry.
Time Frame: 2 years
Correlation coefficients between the continuous criteria of the FDG PET texture parameters and those of the Immunohistochemistry.
2 years
assess the multivariate prognostic value of standard parameters, PET-TDM FDG imaging parameters and Immunohistochemistry defined as relevant to 2-year event-free survival
Time Frame: 2 years
2-year event-free survival rate in multivariate analysis according to standard parameters, PET-TDM FDG imaging parameters and Immunohistochemistry.
2 years
Construction of an optimal prognostic nomogram combining independent parameters to isolate different prognostic subgroups
Time Frame: 2 years
2-year event-free survival rate depending on the risk groups determined from the nomogram score.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Cancerologie de l'Ouest

Investigators

  • Principal Investigator: Caroline ROUSSEAU, MD, PhD, caroline.rousseau@ico.unicancer.fr

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2019

Primary Completion (Actual)

October 22, 2022

Study Completion (Anticipated)

October 22, 2024

Study Registration Dates

First Submitted

January 9, 2020

First Submitted That Met QC Criteria

January 10, 2020

First Posted (Actual)

January 13, 2020

Study Record Updates

Last Update Posted (Estimate)

February 21, 2023

Last Update Submitted That Met QC Criteria

February 20, 2023

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICO-2019-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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