Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT04342546

Predictive Toxicity Test Linked to Radiotherapy After Mastectomy and Immediate Implant Reconstruction

Led by Institut du Cancer de Montpellier - Val d'Aurelle · Updated on 2026-04-13

250

Participants Needed

9

Research Sites

573 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study evaluates the capacity of the NovaGray RILA Breast® test to predict the toxicity linked to radiotherapy and the impact of implant breast reconstruction.

CONDITIONS

Official Title

Predictive Toxicity Test Linked to Radiotherapy After Mastectomy and Immediate Implant Reconstruction

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age �3518 years
  • Patients with histologically confirmed breast cancer with indication of mastectomy or surgery with mastectomy performed
  • Indication of wall chest radiation after mastectomy
  • Patient's agreement to receive or having had an immediate breast reconstruction by implant in one or two steps, with or without a dermal or synthetic matrix (depending on the habits of the center)
  • Performance Status 0-1
  • Consent signed before any study procedure
  • Patient geographically accessible for follow-up
  • Affiliated to the French national social security system
Not Eligible

You will not qualify if you...

  • Breast reconstruction with flap
  • Inflammatory breast cancer (cT4d)
  • Skin or parietal breast cancer (cT4 a, b or c)
  • Metastatic patients
  • Patients with bilateral breast cancer
  • History of homolateral breast cancer treated with radiotherapy
  • History of contralateral breast cancer
  • Pregnant or breastfeeding women
  • Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent
  • Participation in an interventional clinical study or planned participation during study up to 12 months post-radiotherapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 9 locations

1

Centre Georges François Leclerc

Dijon, France, 21079

Actively Recruiting

2

Centre Oscar Lambret

Lille, France, 59000

Actively Recruiting

3

Centre Léon Bérard

Lyon, France, 69373

Actively Recruiting

4

Institut Paoli Calmette

Marseille, France, 13009

Actively Recruiting

5

Institut du Cancer de Montpellier

Montpellier, France, 34298

Actively Recruiting

6

centre Antoine Lacassagne

Nice, France, 06189

Actively Recruiting

7

Hôpital Tenon

Paris, France, 75970

Actively Recruiting

8

Institut de Cancérologie de l'Ouest

Saint-Herblain, France, 44805

Actively Recruiting

9

Institut Claudius Regaud

Toulouse, France, 31059

Actively Recruiting

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Research Team

A

Aurore MOUSSION

CONTACT

E

Emmanuelle TEXIER

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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