Prophylactic Mastectomy: Prospective Evaluation of the Correlation Between Skin Flap Thickness, Residual Glandular Tissue and Skin Necrosis by Imaging and Clinical Examination

NCT05162677 | Recruiting

• 1 other identifier: 2021-PrMa-RWiberg
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer is the most common form of cancer among women. Five to ten percent of all breast cancers are due to hereditary factors, with pathogenic variants in the breast cancer genes BRCA1/2 accounting for 2-5% of all breast cancer. Women with pathogenic variants in BRAC1/2 and other pathogenic gene mutations leading to an increased risk of breast cancer can undergo prophylactic mastectomy, reducing the risk of breast cancer up to 90%. Among women who have undergone prophylactic mastectomy, 1-1,9% are diagnosed with breast cancer, but little is known about the correlation between residual glandular tissue and skin flap thickness, as well as the oncological risk of residual glandular tissue. Furthermore, there is a balance between how much subcutaneous tissue should be resected to achieve maximal reduction of glandular tissue, while leaving viable skin flaps. In addition, there are established surveillance guidelines for women with pathogenic variants in BRCA1/2 who do not undergo risk-reducing surgery, but no published consensus or guidelines regarding appropriate medical follow-up for those who opt for prophylactic mastectomy. The aim of this study is to investigate the correlation between skin flap thickness, residual glandular tissue and skin flap necrosis following prophylactic mastectomy in women with results from postoperative magnetic resonance tomography, ultrasound and physical examination, as well as evaluate patient satisfaction and quality of life pre- and postoperatively with different questionnaires.

Conditions

Prophylactic Mastectomy

Outcome Measures

Primary Outcomes (4)

• Presence of residual glandular tissue

  Residual glandular tissue will be reported as being present or not present through postoperative evaluation with magnetic resonance tomography, ultrasound and mammography. The quadrants of the left and right breast will be examined after which the findings will be documented in pre-printed templates.

  Residual glandular tissue will be evaluated 1 year postoperatively

• Presence of residual glandular tissue

  Residual glandular tissue will be reported as being present or not present through postoperative evaluation with magnetic resonance tomography, ultrasound and mammography. The quadrants of the left and right breast will be examined after which the findings will be documented in pre-printed templates.

  Residual glandular tissue will be evaluated 3 years postoperatively

• Measurement of skin flap thickness

  The skin flap thickness will be evaluated postoperatively with magnetic resonance tomography, ultrasound and mammography. The quadrants of the left and right breast will be examined after which the findings will be documented in pre-printed templates. The skin flap thickness will be defined as the thickness of the skin (epidermis, dermis, subcutaneous tissue) measured at the examinations rather than the thickness of the skin flaps perioperatively. All measurements will be made in mm.

  Skin flap thickness will be evaluated 1 year postoperatively

• Measurement of skin flap thickness

  The skin flap thickness will be evaluated postoperatively with magnetic resonance tomography, ultrasound and mammography. The quadrants of the left and right breast will be examined after which the findings will be documented in pre-printed templates. The skin flap thickness will be defined as the thickness of the skin (epidermis, dermis, subcutaneous tissue) measured at the examinations rather than the thickness of the skin flaps perioperatively. All measurements will be made in mm.

  Skin flap thickness will be evaluated 3 years postoperatively

Secondary Outcomes (5)

• Change in evaluation of patient satisfaction

  Change in patient satisfaction will be evaluated pre- and postoperatively. The women will receive the questionnaires 1 month preoperatively, 1 year postoperatively and 3 years postoperatively.

• Change in evaluation of patient quality of life

  Change in patient quality of life will be evaluated pre- and postoperatively. The women will receive the questionnaires 1 month preoperatively, 1 year postoperatively and 3 years postoperatively.

• Number of participants with acute postoperative complications

  Clinical examination will be performed 2-4 weeks postoperatively.

• Number of participants with long term postoperative complications

  Clinical examination will be performed 1 year postoperatively.

• Number of participants with long term postoperative complications

  Clinical examination will be performed 3 years postoperatively.

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All women with elevated risk of developing breast cancer due to hereditary factors that will undergo prophylactic mastectomy at the Department of Plastic Surgery at Umeå University hospital and forfill the inclusion criteria will be invited to the study.

You may qualify if:

• Women that are recommended prophylactic mastectomy at the Department of Plastic Surgery at Umeå University hospital due to hereditary factors that have been investigated by clinical geneticists.
• Age between 18-74 years

You may not qualify if:

• Women undergoing mastectomy due to cancer.
• Age \< 18 years or \> 74 years.

Sponsors & Collaborators

• Umeå University: lead

Study Sites (1)

Plastic Surgery Unit, Umeå University hospital

Umeå, Sweden

RECRUITING

Related Publications (2)

• Wiberg R, Andersson MN, Svensson J, Rosen A, Koch F, Bjorkgren A, Sund M. Prophylactic Mastectomy: Postoperative Skin Flap Thickness Evaluated by MRT, Ultrasound and Clinical Examination. Ann Surg Oncol. 2020 Jul;27(7):2221-2228. doi: 10.1245/s10434-019-08157-2. Epub 2020 Jan 6.

  PMID: 31907748 BACKGROUND

• Skoglund MA, Andersson MN, Bjorkgren A, Tolocka E, Sund M, Wiberg R. Inter- and intra-observer agreement on evaluating the presence of residual glandular tissue with magnetic resonance tomography following prophylactic mastectomy. Acta Radiol. 2023 Jan;64(1):67-73. doi: 10.1177/02841851211058929. Epub 2021 Dec 1.

  PMID: 34851154 BACKGROUND

Central Study Contacts

Rebecca Wiberg, MD PhD

CONTACT

+4690-785 0000; rebecka.wiberg@umu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident in plastic surgery, PhD

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: December 17, 2021
• Study Start: August 25, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

SE (1)