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

RECRUITINGN/ASponsored by Institut du Cancer de Montpellier - Val d'Aurelle
Actively Recruiting
PhaseN/A
SponsorInstitut du Cancer de Montpellier - Val d'Aurelle
Started2020-12-11
Est. completion2026-06
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted

Summary

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.

Eligibility

Age: 18 Years+Sex: MALEHealthy volunteers accepted
Inclusion Criteria:

* Age ≥18 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

Exclusion Criteria:

* 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

Conditions3

Breast CancerCancerCapsular Contracture Associated With Breast Implant

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