Testing a new tissue engineering device for breast reconstruction after cancer surgery

First-in-human Study of MATTISSE® Tissue Engineering Chamber in Adult Female After Total Mastectomy for Breast Cancer in Immediate or Delayed 2-stage Tissue Expander Reconstruction or Conversion From Implant-based to Autologous Reconstruction

This study is testing a new device to see if it can safely help women who need breast reconstruction after cancer surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Quanta Medical (industry)
• Locations: 3 sites (Strasbourg, France and 2 other locations)
• Trial ID: NCT05460780 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and clinical performance of the MATTISSE tissue engineering chamber in adult female patients undergoing breast reconstruction following mastectomy for cancer. It is a first-in-human, two-stage, single-arm, non-comparative study. The focus is on patients requiring autologous breast reconstruction, either immediately after mastectomy or as a conversion from implant-based reconstruction. The study aims to gather data on the device's effectiveness and safety profile in this specific patient population.

Who should consider this trial

Good fit: Ideal candidates are adult females over 18 years old who require autologous breast reconstruction after mastectomy for early-stage breast cancer.

Not a fit: Patients with advanced breast cancer requiring extensive oncological management or those who cannot undergo the specified surgical procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve breast reconstruction outcomes for women recovering from cancer.

How similar studies have performed: While this is a first-in-human study, similar approaches in tissue engineering have shown promise in other contexts, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

Criteria related to pathology:

* Female patient over 18 Years old
* Patient who required autologous breast reconstruction:

  * Immediate unilateral reconstruction after total mastectomy for early-stage breast cancer
  * Breast reconstruction after unilateral preventive total mastectomy
  * or delayed unilateral reconstruction after total mastectomy for early-stage breast cancer with a tissue expander implantation
  * or conversion from implant-based to autologous reconstruction: Patient who had a breast implant during a previous reconstruction after total mastectomy for cancer, and who needs to change it.
* For patient with active cancer: Patient with early-stage cancer (stage 0, I or II, with tumor size \< 50mm, without lymph-node involvement) needing oncological management that does not required radiotherapy after surgery on the breast area or on the flap donor site
* Patient who required Nipple sparing (NSM) or Skin sparing mastectomy (SSM) with a unique surgical approach (same for mastectomy and implant) insertion; or implant removal for patient undergoing autologous conversion, or expender removal for patient undergoing differed reconstruction.
* Autologous reconstruction using Lateral Intercostal Perforator (LICAP) flap or an intercostal thoracic artery perforation flap (LTAP) if oncological conditions do not allow for LICAP harvesting.
* Patient medically fit for surgery without significant comorbidities
* Breast cup-size less than D
* Body mass index \>20 kg/m2 or patient for whom sufficient flap volume is expected according to surgeon's assessment
* Adequate hematopoietic functions

Criteria related to population:

* Subjects who have given free, informed and written consent to participate in the study;
* Patient able to answer questionnaires, able to communicate in the language of the study country;
* Subjects affiliated to a social security schema or entitled to a social security scheme.

Non-inclusion Criteria:

Pathology related criteria:

* Patient undergoing bilateral reconstruction
* Patient undergoing bilateral preventive mastectomy
* Patient undergoing simultaneous contralateral breast reduction, mastopexy, and augmentation
* Previous history of radiotherapy on the breast area or on the flap donor site
* Previous history of breast or axillary surgery that does not allow fat flap dissection
* Presence of pacemaker or metallic prosthesis making patient unsuitable for MRI
* Body mass index \>30 kg/m2
* Taking medication for weight loss at the time of inclusion visit
* Presence of major medical conditions that may compromise patient's health and healing
* Diabetes and a history of gestational diabetes
* Active smoking
* Microangiopathy, Vascular history and all systemic disease (systemic Raynaud's disease)
* Patient with intertrigo or infection or alteration of the surgical site confirmed pre-operatively by clinical examination
* Allergy to anesthetics or contrast media
* Immunocompromised patient (HIV) or patient used immunosuppressants

Population related criteria

* Pregnant patient
* or breastfeeding patient or woman who has nursed a child three months within inclusion
* Participation in a clinical trial in the 3 months prior to the initial visit
* Predicted unavailability during study.
* Patient deprived of liberty or under guardianship.
* Patient unable to give consent

Medical device related criteria

* Allergy to any of the components of the medical device.

EXCLUSION CRITERIA

* Positive or suspicious extemporaneous sentinel node biopsy
* Non integrity of LICAP and LTAP vessels, showed by the pre-operative doppler
* Patient not yet implanted with MATTISSE®, whose cancer stage will finally require radiotherapy treatment

Where this trial is running

Strasbourg, France and 2 other locations

• CHU de Strasbourg — Strasbourg, France, France (RECRUITING)
• Hospital of Lille — Lille, Nord, France (RECRUITING)
• Institute of Clinical Oncology — Tbilisi, Georgia (RECRUITING)

Study contacts

• Study coordinator: Pierre GUERRESCHI, Pr

Conditions: Breast Cancer Female, Breast Cancer Prevent, Breast Reconstruction