The browser you are using is not supported by this website. All versions of Internet Explorer are no longer supported, either by us or Microsoft (read more here: https://www.microsoft.com/en-us/microsoft-365/windows/end-of-ie-support).

Please use a modern browser to fully experience our website, such as the newest versions of Edge, Chrome, Firefox or Safari etc.

Portrait of Sophia Zackrisson. Photo

Sophia Zackrisson

Research group manager, Principal investigator, Professor, MD

Portrait of Sophia Zackrisson. Photo

The PROCEM study protocol : Added value of preoperative contrast-enhanced mammography in staging of malignant breast lesions - a prospective randomized multicenter study

Author

  • Kristina Åhsberg
  • Anna Gardfjell
  • Emma Nimeus
  • Lisa Ryden
  • Sophia Zackrisson

Summary, in English

Background: Correct preoperative estimation of the malignant extent is crucial for optimal planning of breast cancer surgery. The sensitivity of mammography is lower in dense breasts, and additional imaging techniques are sometimes warranted. Contrast-enhanced mammography (CEM) has shown similar sensitivity and in some cases better specificity, than magnetic resonance imaging (MRI) in small, observational studies. CEM may be more cost-effective than MRI, and may provide better identification of the tumor extent, however, no randomized trials have been performed to date to investigate the added value of CEM. In a feasibility study, we found that the treatment was changed in 10/47 (21%) cases after additional CEM. The purpose of the present study is to evaluate the added value of CEM in preoperative staging of breast cancer in a randomized study. Method: This prospective randomized study will include 440 patients with strongly suspected or established diagnosis of breast malignancy, based on assessment with mammography, ultrasound and core biopsy/cytology, and for whom primary surgery is planned. Patients will be randomized 1:1 using a web-based randomization tool to additional investigation with CEM or no further imaging. The CEM findings will be taken into consideration, which may lead to changes in primary treatment, which is the primary endpoint of this study. Secondary endpoints include rate of reoperation and number of avoidable mastectomies, as well as a cost-benefit analysis of additional CEM. Patient-reported health-related quality of life will be investigated at 1 year with the validated Breast-Q™ questionnaire. The rate of local recurrence or new cancer ipsi- or contralaterally within 5 years will be assessed from medical records and pathology reports. Discussion: The aim of this trial is to explore the added value of CEM in preoperative staging of breast cancer. The results obtained from this study will contribute to our knowledge on CEM as an additional imaging method to standard investigation with digital mammography and ultrasound. The findings may also provide additional information on which patient groups would benefit from CEM, and on the economic aspects of CEM in standard preoperative practice. Trial registration: This trial is registered at clinicaltrials.gov, registration no: NCT04437602, date of registration: June 18, 2020.

Department/s

  • Surgery (Lund)
  • Breast Cancer Surgery
  • LUCC: Lund University Cancer Centre
  • Breast cancer treatment
  • The Liquid Biopsy and Tumor Progression in Breast Cancer
  • Radiology Diagnostics, Malmö
  • EpiHealth: Epidemiology for Health

Publishing year

2021-12

Language

English

Publication/Series

BMC Cancer

Volume

21

Issue

1

Document type

Journal article

Publisher

BioMed Central (BMC)

Topic

  • Cancer and Oncology
  • Radiology, Nuclear Medicine and Medical Imaging

Keywords

  • Breast cancer
  • Contrast-enhanced mammography (CEM)
  • Extent estimation
  • Mastectomy
  • Partial mastectomy
  • Preoperative staging
  • Randomized trial

Status

Published

Research group

  • Breast Cancer Surgery
  • The Liquid Biopsy and Tumor Progression in Breast Cancer
  • Radiology Diagnostics, Malmö

ISBN/ISSN/Other

  • ISSN: 1471-2407