Comparing accuracy of tomosynthesis plus digital mammography or synthetic 2D mammography in breast cancer screening: baseline results of the MAITA RCT consortium.

AIM: The analyses here reported aim to compare the screening performance of digital tomosynthesis (DBT) versus mammography (DM). METHODS: MAITA is a consortium of four Italian trials, REtomo, Proteus, Impeto, and MAITA trial. The trials adopted a two-arm randomised design comparing DBT plus DM (REtomo and Proteus) or synthetic-2D (Impeto and MAITA trial) versus DM; multiple vendors were included. Women aged 45 to 69 years were individually randomised to one round of DBT or DM. FINDINGS: From March 2014 to February 2022, 50,856 and 63,295 women were randomised to the DBT and DM arm, respectively. In the DBT arm, 6656 women were screened with DBT plus synthetic-2D. Recall was higher in the DBT arm (5·84% versus 4·96%), with differences between centres. With DBT, 0·8/1000 (95% CI 0·3 to 1·3) more women received surgical treatment for a benign lesion. The detection rate was 51% higher with DBT, ie. 2·6/1000 (95% CI 1·7 to 3·6) more cancers detected, with a similar relative increase for invasive cancers and ductal carcinoma in situ. The results were similar below and over the age of 50, at first and subsequent rounds, and with DBT plus DM and DBT plus synthetic-2D. No learning curve was appreciable. Detection of cancers >= 20 mm, with 2 or more positive lymph nodes, grade III, HER2-positive, or triple-negative was similar in the two arms. INTERPRETATION: Results from MAITA confirm that DBT is superior to DM for the detection of cancers, with a possible increase in recall rate. DBT performance in screening should be assessed locally while waiting for long-term follow-up results on the impact of advanced cancer incidence.

Contrast-enhanced spectral mammography in neoadjuvant chemotherapy monitoring: a comparison with breast magnetic resonance imaging.

BACKGROUND: Neoadjuvant-chemotherapy (NAC) is considered the standard treatment for locally advanced breast carcinomas. Accurate assessment of disease response is fundamental to increase the chances of successful breast-conserving surgery and to avoid local recurrence. The purpose of this study was to compare contrast-enhanced spectral mammography (CESM) and contrast-enhanced-MRI (MRI) in the evaluation of tumor response to NAC. METHODS: This prospective study was approved by the institutional review board and written informed consent was obtained. Fifty-four consenting women with breast cancer and indication of NAC were consecutively enrolled between October 2012 and December 2014. Patients underwent both CESM and MRI before, during and after NAC. MRI was performed first, followed by CESM within 3 days. Response to therapy was evaluated for each patient, comparing the size of the residual lesion measured on CESM and MRI performed after NAC to the pathological response on surgical specimens (gold standard), independently of and blinded to the results of the other test. The agreement between measurements was evaluated using Lin's coefficient. The agreement between measurements using CESM and MRI was tested at each step of the study, before, during and after NAC. And last of all, the variation in the largest dimension of the tumor on CESM and MRI was assessed according to the parameters set in RECIST 1.1 criteria, focusing on pathological complete response (pCR). RESULTS: A total of 46 patients (85%) completed the study. CESM predicted pCR better than MRI (Lin's coefficient 0.81 and 0.59, respectively). Both methods tend to underestimate the real extent of residual tumor (mean 4.1mm in CESM, 7.5mm in MRI). The agreement between measurements using CESM and MRI was 0.96, 0.94 and 0.76 before, during and after NAC respectively. The distinction between responders and non-responders with CESM and MRI was identical for 45/46 patients. In the assessment of CR, sensitivity and specificity were 100% and 84%, respectively, for CESM, and 87% and 60% for MRI. CONCLUSION: CESM and MRI lesion size measurements were highly correlated. CESM seems at least as reliable as MRI in assessing the response to NAC, and may be an alternative if MRI is contraindicated or its availability is limited.

Diagnostic value of hepatocellular nodule vascularity after microbubble injection for characterizing malignancy in patients with cirrhosis.

OBJECTIVE: The purpose of this study was to assess the diagnostic value of hepatocellular nodule vascularity after microbubble injection for characterization of malignancy in patients with cirrhosis of the liver. MATERIALS AND METHODS: After sulfur hexafluoride-filled microbubble injection, the vascularity of 236 hepatocellular nodules (1-5 cm in diameter) in 215 patients with cirrhosis (151 men, 64 women; mean age, 62 +/- 11 [SD] years) was evaluated by consensus of three reference radiologists. The relation between nodule vascularity in the arterial (10-40 seconds from injection) and portal venous (45 seconds to microbubble disappearance) phases and dimension of malignancy was evaluated by multivariate U statistical analysis. Two blinded independent reviewers using reference criteria classified nodules as benign or malignant after review of unenhanced and contrast-enhanced sonograms. RESULTS: The final diagnoses were 96 malignant (84 hepatocellular carcinoma, 12 tumors not hepatocellular carcinoma) and 140 benign nodules (57 regenerative and 13 dysplastic nodules, 70 other benign lesions). Nodule hypervascularity during the arterial phase and hypovascularity during the portal venous phase (odds ratio, 27.78) and nodule diameter greater than 2 cm combined with hypervascularity during the arterial phase and isovascularity or hypervascularity during the portal venous phase (odds ratio, 3.3) were related to the presence of malignancy. Contrast-enhanced sonography improved diagnostic accuracy (unenhanced sonography vs contrast-enhanced sonography, 32% vs 71% for reviewer 1 and 22% vs 66% for reviewer 2; p < 0.05, McNemar test) even though hypervascular nodules 2 cm or smaller (malignant, n = 2; benign, n = 40) that appeared isovascular or hypervascular during the portal venous phase were misclassified. CONCLUSION: Assessment of hepatocellular nodule vascularity after microbubble injection allowed characterization of malignancy, but characterization was limited for hypervascular nodules 2 cm or less in diameter.

Hypoechoic focal liver lesions: characterization with contrast enhanced ultrasonography.

PURPOSE: To evaluate the late sinusoidal phase of contrast enhancement with a 2nd-generation ultrasound contrast enhanced medium in the characterization of hypoechoic focal liver lesions. METHODS: We studied 88 hypoechoic liver lesions (diameter range, 1-18 cm; with 18 lesions 2 cm or less) found on conventional grayscale sonography (US) with contrast-enhanced ultrasonography (CEUS). Final diagnosis was made using contrast enhanced helical CT, contrast enhanced MR, angiography (DSA), and/or histopathic confirmation or clinical imaging follow-up. RESULTS: There were 37/88 benign lesions demonstrated: 17 cavernous hemangiomas, 3 capillary hemangiomas, 11 focal nodular hyperplasias (FNH), 3 focal areas of sparing in hepatic steatosis, 2 adenomas, and 1 intrahepatic necrotic area. Malignant lesions demonstrated included 51/88: 27 hepatocellular carcinomas (HCC) in cirrhosis, 11 metastatic carcinomas, 10 metastatic endocrine tumors, 2 cholangiocellular carcinomas (CCC) and 1 non-Hodgkin's lymphoma (NHL). CEUS characterized 30/37 (81%) benign lesions and 45/51 (88%) malignant lesions. On the basis of the results obtained during the sinusoidal contrast enhanced phase of CEUS, diagnosis of benignancy was possible in 35/37 (95%) of benign liver lesions and diagnosis of malignancy in 49/51 (96%) of malignant liver lesions. The enhancement pattern of 13 small (< or = 2 cm in diameter) hypervascular liver lesions (3 capillary hemangiomas, 2 FNHs, 4 HCCs, 4 metastatic endocrine tumors) was better demonstrated on CEUS than on helical CT. In these cases the hyper vascularization of the lesions shown on CEUS was not confirmed on CT. CONCLUSIONS: CEUS distinguished malignant from benign hypoechoic liver lesions with an accuracy of 95%.

Standard sonography and arthrosonography in the study of rotator cuff tears.

PURPOSE: The aim of this study was to evaluate the sensitivity of ultrasonography, integrating standard ultrasound and arthrosonography after injecting a saline solution into the glenohumeral cavity in cases of suspected rotator cuff tears. MATERIALS AND METHODS: We prospectively examined 40 patients awaiting shoulder arthroscopy for suspected or diagnosed tears of the rotator cuff. A radiologist, unaware of the pre-operative diagnosis, performed an ultrasound scan on all the patients before and after the injection of saline solution into the glenohumeral cavity. The parameters considered were presence or absence of a rotator cuff injury; type of injury according to Snyder and its extent along the longitudinal and transverse planes; presence or absence of effusion into the articular cavity; subacromial/subdeltoid bursal distension. All the patients underwent arthroscopy either the same day or the day after the ultrasound examination. RESULTS: Standard sonography showed 26 complete rotator cuff tears (type C according to Snyder), 2 partial tears (type B according to Snyder) and 12 intact rotator cuffs. Arthrosonography detected 31 complete rotator cuff tears (type C according to Snyder), 1 partial tear (type B according to Snyder) and 8 intact rotator cuffs.Arthroscopy identified 32 complete rotator cuff tears (type C according to Snyder), 1 partial tear (type B according to Snyder) and 8 intact rotator cuffs. Analysis of the results shows that, taking arthroscopy as the gold standard, the sensitivity of normal sonography is 81.2%, whereas that of arthrosonography is 96.8% (p < 0.05). CONCLUSIONS: On the basis of the data obtained in this study, standard sonography, integrated with the injection of a saline solution into the glenohumeral cavity, considerably increases the diagnostic sensitivity for rotator cuff tears. The authors suggest that arthrosonography can be used in the event of suspected rotator cuff tears, when MRI is contraindicated.

Contrast-enhanced US of hepatocellular carcinoma.

PURPOSE: To evaluate the capabilities of contrast-enhanced ultrasound (CEUS) in the characterization of hepatocarcinoma (HCC) in terms of accuracy as compared to spiral CT and diagnostic gain as compared to conventional and Doppler US. MATERIALS AND METHODS: Forty-three patients with viral hepatopathy or cirrhosis diagnosed with HCC (6 histologically and 37 cytologically proven) were retrospectively studied. Between January 2002 and May 2003, all patients were evaluated with CEUS after detection of at least one suspicious nodule on US. CEUS features of HCCs were retrospectively compared with those on conventional and Doppler US, and spiral CT. RESULTS: HCCs varied between 1.2 cm and 18 cm in diameter; 14/43 were small' (< or = 2 cm). In 18/43 patients, HCC was multifocal. Doppler US revealed 24/43 hypervascular nodules. On CEUS, 37/43 (86%) showed contrast enhancement in the arterial phase, 13/37 (35%) with negative colour and power Doppler US examination; in 6/37 (16%) contrast enhancement in the arterial phase was not visible on spiral CT. On CEUS, 6/43 hypovascular HCCs were characterized as malignant in the sinusoidal phase. On CEUS, the sinusoidal phase revealed additional nodules not visible on baseline US in 3/18 multifocal HCCs. CONCLUSIONS: CEUS diagnosis of HCC in cirrhotic liver is possible with a combination of the arterial phase, which shows tumoral hypervascularity in the microcirculation, and the sinusoidal phase, which allows to confirm the malignancy of the nodule.