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

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Kristina Åhsberg ◽  
Anna Gardfjell ◽  
Emma Nimeus ◽  
Lisa Ryden ◽  
Sophia Zackrisson

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.

2021 ◽  
Vol 28 (4) ◽  
pp. 2548-2559
Author(s):  
Andrzej Lorek ◽  
Katarzyna Steinhof-Radwańska ◽  
Anna Barczyk-Gutkowska ◽  
Wojciech Zarębski ◽  
Piotr Paleń ◽  
...  

Contrast-enhanced spectral mammography (CESM) is a promising, digital breast imaging method for planning surgeries. The study aimed at comparing digital mammography (MG) with CESM as predictive factors in visualizing multifocal-multicentric cancers (MFMCC) before determining the surgery extent. We analyzed 999 patients after breast cancer surgery to compare MG and CESM in terms of detecting MFMCC. Moreover, these procedures were assessed for their conformity with postoperative histopathology (HP), calculating their sensitivity and specificity. The question was which histopathological types of breast cancer were more frequently characterized by multifocality–multicentrality in comparable techniques as regards the general number of HP-identified cancers. The analysis involved the frequency of post-CESM changes in the extent of planned surgeries. In the present study, MG revealed 48 (4.80%) while CESM 170 (17.02%) MFMCC lesions, subsequently confirmed in HP. MG had MFMCC detecting sensitivity of 38.51%, specificity 99.01%, PPV (positive predictive value) 85.71%, and NPV (negative predictive value) 84.52%. The respective values for CESM were 87.63%, 94.90%, 80.57% and 96.95%. Moreover, no statistically significant differences were found between lobular and NST cancers (27.78% vs. 21.24%) regarding MFMCC. A treatment change was required by 20.00% of the patients from breast-conserving to mastectomy, upon visualizing MFMCC in CESM. In conclusion, mammography offers insufficient diagnostic sensitivity for detecting additional cancer foci. The high diagnostic sensitivity of CESM effectively assesses breast cancer multifocality/multicentrality and significantly changes the extent of planned surgeries. The multifocality/multicentrality concerned carcinoma, lobular and invasive carcinoma of no special type (NST) cancers with similar incidence rates, which requires further confirmation.


2018 ◽  
Vol 25 (12) ◽  
pp. 3563-3571 ◽  
Author(s):  
M. Lagendijk ◽  
L. S. E. van Egdom ◽  
F. E. E. van Veen ◽  
E. L. Vos ◽  
M. A. M. Mureau ◽  
...  

2019 ◽  
Vol 2019 ◽  
pp. 1-7 ◽  
Author(s):  
Kun Cao ◽  
Bo Zhao ◽  
Xiao-Ting Li ◽  
Yan-Ling Li ◽  
Ying-Shi Sun

Objectives. MRI is the standard imaging method in evaluating treatment response of breast cancer after neoadjuvant therapy (NAT), while identification of pathologic complete response (pCR) remains challenging. Texture analysis (TA) on post-NAT dynamic contrast-enhanced (DCE) MRI was explored to assess the existence of pCR in mass-like cancer. Materials and Methods. A primary cohort of 112 consecutive patients (40 pCR and 72 non-pCR) with mass-like breast cancers who received preoperative NAT were retrospectively enrolled. On post-NAT MRI, volumes of the residual-enhanced areas and TA first-order features (19 for each sequence) of the corresponding areas were achieved for both early- and late-phase DCE using an in-house radiomics software. Groups were divided according to the operational pathology. Receiver operating characteristic curves and binary logistic regression analysis were used to select features and achieve a predicting formula. Overall diagnostic abilities were compared between TA and radiologists’ subjective judgments. Validation was performed on a time-independent cohort of 39 consecutive patients. Results. TA features with high consistency (Cronbach’s alpha >0.9) between 2 observers showed significant differences between pCR and non-pCR groups. Logistic regression using features selected by ROC curves generated a synthesized formula containing 3 variables (volume of residual enhancement, entropy, and robust mean absolute deviation from early-phase) to yield AUC = 0.81, higher than that of using radiologists’ subjective judgment (AUC = 0.72), and entropy was an independent risk factor (P<0.001). Accuracy and sensitivity for identifying pCR were 83.93% and 70.00%. AUC of the validation cohort was 0.80. Conclusions. TA may help to improve the diagnostic ability of post-NAT MRI in identifying pCR in mass-like breast cancer. Entropy, as a first-order feature to depict residual tumor heterogeneity, is an important factor.


2020 ◽  
Vol 106 (6) ◽  
pp. 480-490
Author(s):  
Michele Divella ◽  
Luigi Vetrugno ◽  
Serena Bertozzi ◽  
Luca Seriau ◽  
Carla Cedolini ◽  
...  

Objective: To investigate the prevalence and risk factors associated with chronic pain and other symptoms related to breast cancer 6 months after surgery. Methods: In an observational study of 261 female breast cancer survivors treated between January 2017 and January 2018, patients were asked about their pain symptoms using a questionnaire that utilized the Numeric Rating Score (NRS) and the Douleur Neuropathique Score (DN4) for neuropathic pain; it also addressed phantom sensations and functional disorders on the ipsilateral shoulder. A total of 218 women completed the survey. Results: A total of 105 patients (48.17%) reported chronic pain. Of these, 64% rated the pain with an NRS of 1–3 and 35% with an NRS >3. Neuropathic pain was reported in 65% of the sample, phantom sensations in 12%, disorders of shoulder function in 16%, and web syndrome in 2%. Multivariable analyses showed that chronic pain (odds ratio [OR], 2.55; 95% confidence interval [CI], 1.094–5.942; p < 0.05) and neuropathic pain (OR, 2.988; 95% CI, 1.366–6.537; p < 0.05) were positively associated with surgical adverse events; phantom sensations were statistically associated with the weight of removed breast tissue (OR, 1.003; 95% CI, 1.001–1.005; p < 0.05). Conclusions: Our study highlights the need to employ specific tools capable of detecting different kinds of chronic pain after breast cancer surgery to improve pain prevention and treatment. Surgical complications and the weight of removed breast tissue emerged as 2 of the risk factors for chronic and neuropathic pain development in breast cancer survivors.


The Breast ◽  
2017 ◽  
Vol 35 ◽  
pp. 14-20 ◽  
Author(s):  
A.W.W. Brown ◽  
M. Kabir ◽  
K.A. Sherman ◽  
F. Meybodi ◽  
J.R. French ◽  
...  

QJM ◽  
2020 ◽  
Vol 113 (Supplement_1) ◽  
Author(s):  
R Abdullah ◽  
L Abdelmonem ◽  
N Nasry ◽  
M Ayoub

Abstract Background Breast cancer in women is a major public health problem throughout the world, being the second most common cancer worldwide. Sonomammography has been always recommended as the basic breast imaging modality for early detection and diagnosis of breast cancer. Some malignant tumors have been missed, specially in dense breasts, and high false-negative rate have been reported. Contrast enhanced spectral mammography is a new modality, used to depict the tumor vascularity and neoangiogenesis; a classic sign of malignant tumors. Aim of Work The purpose of this study is to determine the added value of dual energy contrast mammography to sono-mammography in the assessment of suspicious breast lesions. Patients and Methods 36 patients were included in the study, referred from outpatient clinics in private settings and from Demerdash Hospitals. Contrast enhanced spectral mammography CESM was performed by using a digital mammography unit (Seno DS; GE, Buc, France) that had been adapted to obtain two images for each view: a low-energy image (below the k edge of iodine, 33.2 keV) and a high-energy image (above the k edge of iodine) at 45 to 49 kVp. Results: CEDM versus sonomammography shows p (0.021) value less than 0.05. Also the area under the ROC curve was higher for MX+CEDM (94.4%) than that was for sonomammography (63.8%) compared to pathology analysis with 100% sensitivity, 88.2 % specificity, 90.48 %PPV and 100 % NPV in diagnosis of suspicious lesions. Conclusion The diagnostic accuracy of CEDM+ MX for the detection of breast carcinoma has proven to be superior to sonomammography alone. CEDM had a better diagnostic accuracy mainly due to improved positive and negative predictive values (Positive predictive value about 90.48, negative predictive value 100). The role of CEDM in detection of multifocal / multicentric carcinomas with particular interest for the assessment of the extent of disease specially in dense breasts is appreciated.


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