Breast Reconstruction Following Mastectomy with fat transplantation and stem cells from fat tissue

Phase 1

• Conditions: This study will include patients with genetic predisposition to development of breast cancer, who are offered prophylactic bilateral skin-sparring mastectomy.; MedDRA version: 20.0Level: PTClassification code 10071981Term: BRCA2 gene mutationSystem Organ Class: 10018065 - General disorders and administration site conditions; MedDRA version: 20.0Level: PTClassification code 10071980Term: BRCA1 gene mutationSystem Organ Class: 10018065 - General disorders and administration site conditions; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2016-005186-31-DK
• Lead Sponsor: Department of Plastic Surgery, Breast and Burns Treatment

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-30
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

1.Age 25 - 45 years (25 and 45 included)
2.Females who are offered prophylactic, bilateral nipple-sparring mastectomy due to an estimated familial predisposition to develop breast cancer.
3.Patients who are deemed fit for breast reconstruction with fat grafting by a plastic surgeon in terms of available fat supply, breast symmetry and small, non-ptotic breast mound.
4.Signed informed consent by the patient
5.Mutual agreement on acceptable breast volume for point of complete reconstruction between patient and surgeon.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Smoking.
2.Diabetes or other comorbidities that may increase the risk of surgical complications assessed by the surgeon.
3.Genetic syndromes associated with high risk of cancers other than breast- and ovarian cancer.
4.Previous- or planned radiotherapy.
5.Asymmetry of the breasts or thorax.
6.Pacemaker or other implanted foreign objects in the vicinity of the breast.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified