A Pilot Randomized Controlled Trial of an mHealth Intervention to Improve PrEP Adherence Among Young Sexual Minority Men.

This randomized controlled study assessed the feasibility, acceptability, and preliminary impact of the PrEP iT! mHealth intervention designed to improve PrEP adherence among young men who have sex with men (YMSM). A national sample of 80 YMSM in the U.S. (Mage = 25 years; 54% racial/ethnic minority), recruited through social media ads, were randomized to either the PrEP iT! or usual PrEP care conditions. Participants completed online surveys and submitted self-collected dried blood sample (DBS) data as measures of PrEP adherence. Differences in PrEP adherence across treatment arms and between participants with high versus low engagement in PrEP iT! were assessed. Retention was high at the three (94%) and six (93%) month assessment, and participants in PrEP iT! reported satisfactory acceptability of the intervention. There were no significant differences in self-reported or DBS-derived PrEP adherence between randomized groups. However, YMSM in the PrEP iT! group with high PrEP adherence (the equivalent of four or more doses/week through self-report and DBS-derived measures) demonstrated significantly higher engagement in the intervention than those with low PrEP adherence (the equivalent of 3 or fewer doses/week). Overall, the PrEP iT! intervention demonstrated strong feasibility and acceptability. The finding that high PrEP iT! intervention engagement was associated with protective levels of PrEP adherence suggests it is a viable adherence support tool that should be further evaluated in definitive trial among YMSM who need basic support, or as part of a more comprehensive adherence support package for those who need greater assistance.Trial registration Clinical Trials # NCT04509076 (registered August 10, 2020).

Comparison of Diagnostic Mammography-Guided Biopsy and Digital Breast Tomosynthesis-Guided Biopsy of Suspicious Breast Calcifications: Results in 1354 Biopsies.

BACKGROUND. Studies have shown improved targeting and sampling of noncalcified lesions (asymmetries, masses, and architectural distortion) with digital breast tomosynthesis (DBT)-guided biopsy in comparison with digital mammography (DM)-guided stereotactic biopsy. Literature that compares the two techniques specifically for sampling calcifications has been scarce. OBJECTIVE. The purpose of this study was to compare the performance and outcomes of DM- and DBT-guided biopsy of suspicious calcifications. METHODS. This retrospective study included 1310 patients (mean age, 58 ± 12 [SD] years) who underwent a total of 1354 9-gauge vacuum-assisted core biopsies of suspicious calcifications performed at a single institution from May 22, 2017, to December 31, 2021. The decision to use a DM-guided or DBT-guided technique was made at the discretion of the radiologist performing the biopsy. Procedure time, the number of exposures during the procedure, and the histopathologic outcomes were recorded. The two techniques were compared using a two-sample t test for continuous variables and a chi-square test for categoric variables. Additional tests were performed using generalized estimating equations to control for the effect of the individual radiologist performing the biopsy. RESULTS. A total of 348 (26%) biopsies used DM guidance, and 1006 (74%) used DBT guidance. The mean procedure time was significantly lower for DBT-guided biopsy (14.9 ± 8.0 [SD] minutes) than for DM-guided biopsy (24.7 ± 14.3 minutes) (p < .001). The mean number of exposures was significantly lower for DBT-guided biopsy (4.1 ± 1.0 [SD] exposures) than for DM-guided biopsy (9.1 ± 3.3 exposures) (p < .001). The differences in procedure time and number of exposures remained significant (both p < .001) when controlling for the effect of the radiologist performing the biopsy. There were no significant differences (all p > .05) between DM-guided and DBT-guided biopsy in terms of the malignancy rate on initial biopsy (20% vs 19%), the rate of high-risk lesion upgrading (14% vs 22%), or the final malignancy rate (23% vs 22%). CONCLUSION. DBT-guided biopsy of suspicious calcifications can be performed with shorter procedure time and fewer exposures compared with DM-guided biopsy, without a significant difference in rates of malignancy or high-risk lesion upgrading. CLINICAL IMPACT. The use of a DBT-guided, rather than a DM-guided, biopsy technique for suspicious calcifications can potentially reduce patient discomfort and radiation exposure without affecting clinical outcomes.

Attitudes Toward and Beliefs in the Effectiveness of Biomedical HIV Prevention Strategies Among Emerging and Young Adult Sexual Minority Men.

BACKGROUND: Pre-exposure prophylaxis (PrEP) and HIV treatment as prevention, which underlies the Undetectable = Untransmittable (U = U) campaign, are two effective biomedical approaches for HIV prevention among sexual minority men (SMM). Attitudes toward PrEP and U = U may differ between SMM emerging adults (EA: 18-24 years old) and young adults (YA: 25-29 years old) to drive differences in sexual behavior. However, to date, few studies assessed the degree to which YAs and EAs differ in their beliefs in the effectiveness of PrEP and U = U. METHOD: A national sample of 80 SMM in the USA (Mage = 25.1 years; 53.7% racial/ethnic minority; 38.8% EA; 61.3% YA) participated in a 6-month mHealth intervention for PrEP adherence. Non-parametric tests assessed differences in sexual behaviors and attitudes toward the effectiveness of PrEP and U = U between EAs and YAs using baseline data. RESULTS: Compared to EAs, higher proportions of YAs trusted PrEP's effectiveness and considered condom use unnecessary after taking PrEP. More YAs than EAs were willing to engage in sexual behaviors that they felt too risky before learning about U = U and were more comfortable having condomless sex with HIV-positive partners. Conversely, a greater proportion of EAs than YAs preferred to use condoms even when their partners are on anti-HIV medications. CONCLUSION: Overall, YAs trusted the effectiveness of U = U and PrEP more than EAs, underscoring developmental differences in SMM's perspectives on biomedical HIV prevention tools. Our findings underscore the importance of tailoring messages on biomedical HIV prevention options differently for EAs and YAs to optimize uptake.

High-risk lesions in the breast diagnosed by MRI-guided core biopsy: upgrade rates and features associated with malignancy.

PURPOSE: This study assessed the upgrade rates of high-risk lesions (HRLs) in the breast diagnosed by MRI-guided core biopsy and evaluated imaging and clinical features associated with upgrade to malignancy. METHODS: This IRB-approved, retrospective study included MRI-guided breast biopsy exams yielding HRLs from August 1, 2011, to August 31, 2020. HRLs included atypical ductal hyperplasia (ADH), lobular carcinoma in situ (LCIS), atypical lobular hyperplasia (ALH), radial scar, and papilloma. Only lesions that underwent excision or at least 2 years of MRI imaging follow-up were included. For each HRL, patient history, imaging features, and outcomes were recorded. RESULTS: Seventy-two lesions in 65 patients were included in the study, with 8/72 (11.1%) of the lesions upgraded to malignancy. Upgrade rates were 16.7% (2/12) for ADH, 100% (1/1) for pleomorphic LCIS, 40% (2/5) for other LCIS, 0% (0/19) for ALH, 0% (0/18) for papilloma, and 0% (0/7) for radial scar/complex sclerosing lesion. Additionally, two cases of marked ADH bordering on DCIS and one case of marked ALH bordering on LCIS, were upgraded. Lesions were more likely to be upgraded if they presented as T2 hypointense (versus isotense, OR 6.46, 95% CI 1.27-32.92) or as linear or segmental non-mass enhancement (NME, versus focal or regional, p = 0.008). CONCLUSION: Our data support the recommendation that ADH and LCIS on MRI-guided biopsy warrant surgical excision due to high upgrade rates. HRLs that present as T2 hypointense, or as linear or segmental NME, should be viewed with suspicion as these were associated with higher upgrade rates to malignancy.

Developing Asymmetries without Sonographic Correlate at Digital Breast Tomosynthesis.

Background Digital breast tomosynthesis (DBT) has improved the accuracy of mammography, including resolving many breast asymmetries as overlapping breast tissue. The pathologic outcomes of persistent developing asymmetries visualized at DBT are not well established. Purpose To characterize the outcomes and the predictors of malignancy for developing asymmetries visualized at DBT without a sonographic correlate. Materials and Methods This retrospective study included all tomosynthesis-guided biopsies of developing asymmetries performed at a single institution from May 2017 through January 2020. A reader study including three breast imaging radiologists determined interrater agreement and inclusion into the study. Electronic medical records were used to extract patient characteristics, imaging characteristics, and pathologic diagnoses. The Wilcoxon rank sum test, Fisher exact test, and χ2 test were used to analyze correlations of patient and imaging characteristics with likelihood of malignancy. Results The reader study included 95 DBT examinations with moderate interrater reliability (Fleiss κ = 0.45). There was majority reader agreement in 85 of the 95 DBT examinations (89%) of 83 women (median age, 56 years; interquartile range, 47-69 years), and this finalized the study data set. At pathologic examination, most asymmetries (68 of 85, 80%) were benign, with common diagnoses being fibrocystic change (n = 20), stromal fibrosis (n = 10), and fat necrosis (n = 10). The overall malignancy rate was 20% (17 of 85 asymmetries; 95% CI: 12, 29); 15 of the 17 malignancies (88%) were invasive cancers. Malignancies were more common in women with a personal history of breast cancer (35% vs 10%, P = .02). Conclusion In 85 developing asymmetries visualized at digital breast tomosynthesis without a sonographic correlate, there was a 20% (95% CI: 12, 29) malignancy rate, which was higher than the rates of malignancy for a developing asymmetry detected at digital mammography. © RSNA, 2021 See also the editorial by Skaane in this issue.

COVID-19 Vaccine-Related Axillary Adenopathy on Breast Imaging: Follow-Up Recommendations and Histopathologic Findings.

This study describes 94 patients who presented with suspected COVID-19 vaccine-related axillary adenopathy on breast imaging. All biopsies recommended within 12 weeks of the second vaccine dose were benign. Among women not recommended for biopsy, the median interval between the second vaccine dose and ultrasound follow-up was 15.9 weeks. Three biopsies yielding malignant diagnoses were recommended 12.0-13.1 weeks after the second vaccine dose. Lengthening imaging follow-up to 12-16 weeks after the second dose may reduce unnecessary biopsy recommendations.

Comparison of Outcomes for One-View Asymmetries Recalled From Digital Breast Tomosynthesis Versus Full-Field Digital Mammography Screening Examinations.

BACKGROUND. Recall rates are lower for digital breast tomosynthesis (DBT) than for full-field digital mammography (FFDM). This difference could have important implications with respect to one-view asymmetries given that missed cancers are often visible on one view. OBJECTIVE. The purpose of this study is to compare the outcomes of one-view asymmetries recalled from DBT versus FFDM screening examinations and to determine predictors of malignancy among recalled asymmetries. METHODS. This retrospective study first determined recall rates associated with one-view asymmetries for screening mammography performed using DBT and FFDM from July 14, 2016, through July 14, 2020. Further analyses included patients recalled for a one-view asymmetry who completed subsequent diagnostic workup and all recommended follow-up. Patient and cancer characteristics were extracted from the electronic health record. RESULTS. The recall rate associated with asymmetries was lower for DBT screening (2.5% [3169/128,755]) than for FFDM screening (3.4% [815/23,898]) (p < .001). Further analyses of patients who completed diagnostic workup and subsequent follow-up included 3119 patients (mean age, 57 years) for DBT screening and 811 patients (mean age, 56 years) for FFDM screening. Distribution of final BI-RADS categories from subsequent diagnostic workup was not different between the two modalities (p > .99). The frequency of malignancy was not different between asymmetries recalled from DBT (1.7% [54/3119]) and FFDM (1.7% [14/811]) (p > .99). Malignant asymmetries identified on FFDM versus DBT were more frequently associated with architectural distortion on diagnostic workup (35.7% [5/14] vs 9.3% [5/54]) (p < .001) and were more commonly invasive ductal carcinoma (92.9% vs 57.4%) and less commonly invasive lobular carcinoma (0.0% vs 24.1%) (p = .05). In multivariable analysis, independent predictors of malignancy among recalled asymmetries from DBT were age (for 55-69 years, odds ratio [OR] = 2.40 [p = .04]; for ≥ 70 years, OR = 7.93 [p < .001]; reference, < 55 years) and breast density (not dense, OR = 2.47 [p = .001]; reference, dense breasts). CONCLUSION. Recalled asymmetries were less frequent for DBT than for FFDM. The malignancy rate was low for both modalities (1.7%). Age 55 years old and older and lower breast density predicted malignancy for DBT-recalled asymmetries. CLINICAL IMPACT. Our results support the use of DBT to reduce unnecessary recalls without altering PPV for asymmetry-associated malignancies. Patient factors should be considered when assessing whether a potential asymmetry on DBT screening represents overlapping fibroglandular tissue or a suspicious finding that requires diagnostic workup.

Presentation and characteristics of breast cancer in young women under age 40.

PURPOSE: Although uncommon, breast cancer is the leading cause of cancer death in young women. There are limited studies on the presentation and characteristics of breast cancer in women under age 40. METHODS: This is a retrospective study investigating patient demographics, clinical presentations, imaging findings, and cancer characteristics of a cohort of 145 women under age 40 with breast cancer. RESULTS: Our cohort had more aggressive cancer subtypes than reported in older women; 33.1% triple negative, 80% high Ki-67, and 21.3% with stage 3+ disease. Most were referred from primary care or obstetrician/gynecologist, though 5.5% initially presented from the emergency department and another 2.1% were incidental findings. 16.6% of patients presented while pregnant or breastfeeding. Most patients presented with breast related symptoms. Of the 9.1% of patients diagnosed through our high-risk screening program, 84.6% of the cancers were identified on mammography or simultaneously with mammography and MRI. Most breast cancers presented with typically worrisome imaging (82.6%), though several cancers presented with findings that were typically benign. CONCLUSIONS: We recommend prompt breast imaging for young women presenting with breast-related symptoms or an incidental breast finding, as younger patients have more aggressive cancer subtypes and are of a higher grade at presentation compared to older women. We also recommend vigilance when distinguishing suspicious symptoms from pregnancy-related breast changes to minimize delays in diagnosis. Additionally, it is important to identify patients who qualify for high risk screening, since cancers in screening patients were found at a lower grade than those presenting with symptoms.

Diagnostic Versus Screening Mammography Recommendations for Postlumpectomy Imaging Surveillance of Patients With Breast Cancer.

Among 707 women who were recommended to undergo annual diagnostic mammography (DM) surveillance after lumpectomy for breast cancer, 94.9%, 90.4%, and 84.3% of women presented for DM at years 1, 2, and 3 after lumpectomy. A total of 18.8%, 11.0%, and 9.9% of women received additional views at years 1, 2, and 3, compared with the 10.1% institutional screening recall rate. The postlumpectomy year 3 cancer detection rate of 11.7 cancers per 1000 DM examinations was below DM benchmarks. These preliminary findings suggest that returning to screening mammography may be acceptable after 1 year of postlumpectomy DM follow-up.

Tomosynthesis-Guided Vacuum-Assisted Breast Biopsy of Architectural Distortion Without a Sonographic Correlate: A Retrospective Review.

BACKGROUND. Digital breast tomosynthesis-guided vacuum-assisted breast biopsy (DBT VAB) allows biopsy of findings seen better or exclusively on digital breast tomosynthesis (DBT), including architectural distortion. Although architectural distortion with an associated sonographic mass correlate has a high risk of malignancy, limited data describe the radiologic-pathologic correlation of tomosynthesis-detected architectural distortion without a sonographic correlate. OBJECTIVE. This study evaluates the malignancy rate of architectural distortions without a sonographic correlate that undergo DBT VAB and provides radiologic-pathologic correlation for benign, high-risk, and malignant entities that are associated with architectural distortion. METHODS. We retrospectively reviewed imaging, as well as pathology slides and/or reports, for DBT VABs performed for architectural distortion without a sonographic correlate at a single institution between June 1, 2017, and January 15, 2020. According to the correlative histopathology, cases were categorized as benign, high risk, or malignant, and specific histopathologic diagnoses were summarized. RESULTS. During the study period, 142 patients (mean age, 59 years) underwent DBT VAB for 151 unique architectural distortions without a sonographic correlate. DBT VAB revealed a malignant diagnosis in 27 (18%), a high-risk lesion in 50 (33%), and a benign diagnosis in 74 (49%). Two cases of atypical ductal hyperplasia were upgraded to malignancy, resulting in a final malignancy rate of 19% (n = 29/151). Most malignant lesions were invasive carcinomas (83%, n = 24/29); most invasive carcinomas were of lobular subtype (54%, n = 13/24). Most high-risk lesions were radial scars/complex sclerosing lesions (62%, n = 31/50). Most benign results represented fibrocystic change (66%, n = 49/74). A subset (11%, n = 8/74) of benign results were considered discordant and subsequently excised, with none representing malignancy. CONCLUSION. The final malignancy rate of 19% in architectural distortion without a sonographic correlate justifies a recommendation for biopsy using DBT VAB. CLINICAL IMPACT. Our results highlight the utility of DBT VAB in the era of DBT. The detailed radiologic-pathologic correlations will assist radiologists in assessing concordance when performing DBT VAB for architectural distortions and provide a reference for future patient management.