ABSTRACT
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.
Subject(s)
Breast Neoplasms/diagnostic imaging , Contrast Media/administration & dosage , Mammography/methods , Neoplasm Staging/methods , Biopsy, Large-Core Needle , Breast/diagnostic imaging , Breast/pathology , Breast Neoplasms/pathology , Breast Neoplasms/surgery , Cost-Benefit Analysis , Female , Humans , Magnetic Resonance Imaging , Mammography/economics , Mastectomy , Neoplasm Recurrence, Local , Preoperative Care , Prospective Studies , Quality of Life , Reoperation , Sensitivity and Specificity , Ultrasonography, MammaryABSTRACT
The purpose of this article is to report on 23 women with evidence of axillary adenopathy at breast imaging after recent COVID-19 vaccination. A total of 13% of patients had symptoms (axillary lump), 43% were undergoing screening, and 43% were undergoing diagnostic imaging for other reasons. BI-RADS category 2 was assigned in one case, BI-RADS 3 in 21 (ultrasound in 4-24 weeks), and BI-RADS 4 in one. Radiologist familiarity and evidence-based guidelines are needed to avoid follow-up imaging and biopsies for reactive adenopathy after COVID-19 vaccination.
Subject(s)
COVID-19 Vaccines/adverse effects , COVID-19/prevention & control , Lymphadenopathy/diagnostic imaging , Lymphadenopathy/etiology , Mammography/methods , Ultrasonography, Mammary/methods , Adult , Axilla , COVID-19 Vaccines/therapeutic use , Female , Follow-Up Studies , Humans , Incidental Findings , Middle Aged , Retrospective Studies , SARS-CoV-2Subject(s)
Breast Neoplasms/diagnostic imaging , COVID-19 , Image-Guided Biopsy/statistics & numerical data , Mammography/statistics & numerical data , Ultrasonography, Mammary/statistics & numerical data , Appointments and Schedules , Breast Neoplasms/pathology , Breast Neoplasms/surgery , Elective Surgical Procedures , Female , Florida , Humans , Magnetic Resonance Imaging/statistics & numerical dataABSTRACT
BACKGROUND/AIM: Coronavirus-19 (COVID-19) pandemic outbreak is currently having a huge impact on medical resource allocation. Breast Cancer (BC) patients are concerned both with BC treatment and COVID-19. This study aimed to estimate the impact of anxiety among patients, caused by the spreading of COVID-19. PATIENTS AND METHODS: Between the 16th of January and the 20th of March 2020, we retrospectively enrolled 160 patients. Eighty-two patients with a suspected breast lesion (SBL) were divided into two groups: PRE-COVID-19-SBL and POST-COVID-19-SBL. Seventy-eight BC patients were divided into PRE-COVID-19-BC and POST-COVID-19-BC. Patient characteristics including age, marital status, SBL/BC diameter, personal and family history of BC, clinical stage and molecular subtype were recorded. Procedure Refusal (PR) and Surgical Refusal (SR) were also recorded with their reason. RESULTS: BC and SBL analysis showed no difference in pre-treatment characteristics (p>0.05). Both POST-COVID-19-SBL and POST-COVID-19-BC groups showed higher rates of PR and SR (p=0.0208, p=0.0065 respectively). Infection risk represented primary reason for refusal among POST-COVID-19 patients. CONCLUSION: COVID-19-related anxiety could affect patients' decision-making process.