Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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