Rapid Access to Contrast-Enhanced spectral mammogRaphy in women recalled from breast cancer screening: the RACER trial study design

Autor: F. B. M. Sanders, L. M. F. H. Neeter, Ruud M. Pijnappel, T. J. A. van Nijnatten, I. P. L. Houben, Marjolein L. Smidt, Marc B. I. Lobbes, Brigitte A. B. Essers, Patty J. Nelemans, M. Osinga-de Jong, T. van Dalen, Joachim E. Wildberger, C. Frotscher, H.P.J. (Frank) Raat
Přispěvatelé: Promovendi ODB, Beeldvorming, MUMC+: DA BV Medische staf (6), RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Epidemiologie, RS: CAPHRI - R5 - Optimising Patient Care, MUMC+: DA BV AIOS Radiologie (9), MUMC+: KIO Kemta (9), RS: CAPHRI - R2 - Creating Value-Based Health Care, MUMC+: DA Beeldvorming (5), RS: Carim - B06 Imaging, RS: CARIM - R3.11 - Imaging, Surgery, MUMC+: MA Heelkunde (9), MUMC+: DA BV Medisch Specialisten Radiologie (9)
Jazyk: angličtina
Rok vydání: 2019
Předmět:
Pediatrics
medicine.medical_specialty
Digital mammography
Breast imaging
Cost-Benefit Analysis
Biopsy
Fine-Needle
Contrast Media
Medicine (miscellaneous)
Breast Neoplasms
Anxiety
Health Services Accessibility
030218 nuclear medicine & medical imaging
law.invention
Study Protocol
03 medical and health sciences
Breast cancer screening
0302 clinical medicine
Breast cancer
Randomized controlled trial
law
medicine
PROGRAM
Humans
Mammography
Pharmacology (medical)
Breast
DIGITAL MAMMOGRAPHY
Early Detection of Cancer
Netherlands
Cancer
lcsh:R5-920
medicine.diagnostic_test
business.industry
Contrast-enhanced spectral mammography
Retrospective cohort study
Health Care Costs
medicine.disease
Magnetic Resonance Imaging
Tomosynthesis
DIAGNOSTIC PERFORMANCE
030220 oncology & carcinogenesis
Screening
Female
Biopsy
Large-Core Needle
Ultrasonography
Mammary
lcsh:Medicine (General)
business
Zdroj: Trials, 20(1):759. BioMed Central Ltd
Trials
Trials, 20(1). BioMed Central
Trials, Vol 20, Iss 1, Pp 1-10 (2019)
ISSN: 1745-6215
Popis: Background In the Dutch breast cancer screening program, women recalled with a BI-RADS 0 score are referred for additional imaging, while those with BI-RADS 4/5 scores are also directed to an outpatient breast clinic. Approximately six out of ten women are recalled without being diagnosed with a malignancy. However, these recalls require additional imaging and doctor visits, which result in patient anxiety and increased health care costs. Conventional types of imaging used for additional imaging are full-field digital mammography and tomosynthesis. Contrast-enhanced spectral mammography has proved to have higher sensitivity and specificity than conventional imaging in women recalled from screening. Therefore, the aim is to study if CESM instead of conventional imaging is a more accurate, patient-friendly, and cost-effective strategy in the work-up of women recalled from breast cancer screening. Methods This prospective, multicenter, randomized controlled trial will be conducted at four centers and will include 528 patients recalled for suspicious breast lesions from the Dutch breast cancer screening program. Participants are randomized in two groups: (1) standard care using conventional breast imaging techniques as initial imaging after recall versus (2) work-up primarily based on CESM. Written informed consent will be collected prior to study inclusion. The primary outcome is the diagnostic accuracy for detection of breast cancer. Secondary outcomes are numbers of additional diagnostic exams, days until final diagnosis, health care costs, and experienced patient anxiety. Discussion Based on previously published retrospective studies, we expect to demonstrate in this prospective multicenter randomized controlled trial, that using CESM as a primary work-up tool in women recalled from breast cancer screening is a more accurate, cost-effective, and patient-friendly strategy. Trial registration Netherlands Trial Register, NL6413/NTR6589. Registered on 6 July, 2017.
Databáze: OpenAIRE
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