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PURPOSE: To investigate the feasibility and accuracy of radiologists categorizing the method of detection (MOD) when performing image-guided breast biopsies. METHODS: This retrospective, observational study was conducted across a health care enterprise that provides breast imaging services at 18 imaging sites across four US states. Radiologists used standardized templates to categorize the MOD, defined as the first test, sign, or symptom that triggered the subsequent workup and recommendation for biopsy. All image-guided breast biopsies since the implementation of the MOD-inclusive standardized template-from October 31, 2017 to July 6, 2023-were extracted. A random sample of biopsy reports was manually reviewed to evaluate the accuracy of MOD categorization. RESULTS: A total of 29,999 biopsies were analyzed. MOD was reported in 29,423 biopsies (98.1%) at a sustained rate that improved over time. The 10 MOD categories in this study included the following: 15,184 mammograms (51.6%); 4,561 MRIs (15.5%); 3,473 ultrasounds (11.8%); 2,382 self-examinations (8.1%); 2,073 tomosynthesis studies (7.0%); 432 clinical examinations (1.5%); 421 molecular breast imaging studies (1.4%); 357 other studies (1.2%); 338 contrast-enhanced digital mammograms (1.1%); and 202 PET studies (0.7%). Original assignments of the MOD agreed with author assignments in 87% of manually reviewed biopsies (n = 100, 95% confidence interval: [80.4%, 93.6%]). CONCLUSIONS: This study demonstrates that US radiologists can consistently and accurately categorize the MOD over an extended time across a health care enterprise.

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OBJECTIVE: Molecular breast imaging (MBI) is a supplemental screening modality consistently demonstrating incremental cancer detection over mammography alone; however, its lengthy duration may limit widespread utilization. The study purpose was to assess feasibility of an abbreviated MBI protocol, providing readers with mediolateral oblique (MLO) projections only and assessing performance in lesion detection and localization. METHODS: Retrospective IRB-exempt blinded reader study administered to 5 fellowship-trained breast imaging radiologists. Independent reads performed for 124 screening MBI cases, half abnormal and half negative/normal. Readers determined whether an abnormality was present, side of abnormality, and location of abnormality (medial/lateral). Abnormal cases had confirmatory biopsy or surgical pathology; normal cases had imaging follow-up ensuring true negative results. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated to assess performance. A false negative result indicated that a reader failed to detect abnormal uptake; a false positive result indicated a reader incorrectly called an abnormality for a negative case. Tests for association included chi-square, Fisher-exact, and analysis of variance. RESULTS: Mean reader performance for detecting abnormal uptake: sensitivity 96.8%, specificity 98.7%, PPV 98.8%, and NPV 96.9%. Accuracy in localizing lesions to the medial or lateral breast was 100%. There were no associations in reader performance with reader experience, reader technique, lesion morphology, or lesion pathology. Median lesion size was 1.0 cm (range: 0.4-8.0 cm). All readers correctly identified 97.7% (42/43) of lesions with malignant or elevated risk pathology. CONCLUSION: An abbreviated MBI protocol (MLO images only) maintained high accuracy in lesion detection and localization.

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OBJECTIVE: Image-guided breast biopsies are safe, efficient, and reliable. However, patients are often anxious about these procedures, particularly those who have never undergone a prior biopsy. METHODS: This prospective IRB-approved study surveyed 163 patients undergoing their first breast biopsy. Participants provided informed consent and completed a short written survey prior to and immediately after their procedure. Level of anxiety as well as anticipated and actual levels of pain prior to and following the procedure were assessed using a 0-10-point Likert scale. Correlation, bivariate, and regression analyses were performed. RESULTS: Regarding the biopsy experience, 133/163 (81.6%) of patients reported it as better than expected. Anxiety decreased significantly from a prebiopsy mean score of 5.52 to a postbiopsy mean score of 2.25 (P < 0.001). Average and greatest pain experienced during the procedure had mean scores of 2.03 and 2.77, respectively, both significantly lower compared to preprocedural expectation (mean 4.53) (P < 0.001). Lower pain scores were reported in US-guided procedures compared to stereotactic- and MRI-guided biopsies (P < 0.001). No significant differences in pain scores were seen in those undergoing single versus multiple biopsies, or when benign, elevated-risk, or malignant lesions were sampled. Positive correlations were seen with prebiopsy anxiety levels and procedural pain as well as with anticipated pain and actual procedural pain. CONCLUSION: Image-guided biopsies are often better tolerated by patients than anticipated. We stress the benefit of conveying this information to patients prior to biopsy, as decreased anxiety correlates with lower levels of pain experienced during the procedure.

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OBJECTIVE: Parenchymal breast cysts are considered to be rare in men and are sparsely described in the literature. The purpose of this study was to review our institution's experience with male breast cysts in an effort to improve overall understanding and management of this rare entity. METHODS: An institutional review board-exempt retrospective study was performed. Radiology reports for males who underwent mammogram and/or breast ultrasound at any of our institution's primary or satellite locations from January 1995 to January 2020 were screened to find males with breast cysts. If cysts were reported and images were available, case review was performed to confirm parenchymal breast cyst(s) and patient characteristics were collated. RESULTS: Of 5425 male cases presenting for breast imaging, 19 (0.4%) cases of male breast cysts were confirmed, with a mean patient age of 41.6 years (range: 2-81 years). The most common indication leading to cyst discovery was a palpable lump, corresponding to the site of the cyst in 5 (26.3%) patients and near the site where cyst(s) were ultimately discovered in 7 (36.8%) patients. There were 8 (42.1%) instances of cysts without concurrent gynecomastia. Three (15.8%) men underwent needle sampling. There were no cases of atypia or malignancy on needle biopsy or on subsequent clinical follow-up, with median clinical follow-up of 70.3 months (range: 3.3-259.4 months). CONCLUSION: Male breast parenchymal cysts are rare, but their prevalence is likely underestimated. If detected incidentally or upon targeted evaluation, biopsy may be averted if classic benign cyst features are identified.

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OBJECTIVE. The purpose of this study was to assess the diagnostic performance of supplemental screening molecular breast imaging (MBI) in women with mammographically dense breasts after system modifications to permit radiation dose reduction. SUBJECTS AND METHODS. A total of 1651 asymptomatic women with mammographically dense breasts on prior mammography underwent screening mammography and adjunct MBI performed with 300-MBq (99m)Tc-sestamibi and a direct-conversion (cadmium zinc telluride) gamma camera, both interpreted independently. The cancer detection rate, sensitivity, specificity, and positive predictive value of biopsies performed (PPV3) were determined. RESULTS. In 1585 participants with a complete reference standard, 21 were diagnosed with cancer: two detected by mammography only, 14 by MBI only, three by both modalities, and two by neither. Of 14 participants with cancers detected only by MBI, 11 had invasive disease (median size, 0.9 cm; range, 0.5-4.1 cm). Nine of 11 (82%) were node negative, and two had bilateral cancers. With the addition of MBI to mammography, the overall cancer detection rate (per 1000 screened) increased from 3.2 to 12.0 (p < 0.001) (supplemental yield 8.8). The invasive cancer detection rate increased from 1.9 to 8.8 (p < 0.001) (supplemental yield 6.9), a relative increase of 363%, while the change in DCIS detection was not statistically significant (from 1.3 to 3.2, p =0.250). For mammography alone, sensitivity was 24%; specificity, 89%; and PPV3, 25%. For the combination, sensitivity was 91% (p < 0.001); specificity, 83% (p < 0.001); and PPV3, 28% (p = 0.70). The recall rate increased from 11.0% with mammography alone to 17.6% (p < 0.001) for the combination; the biopsy rate increased from 1.3% for mammography alone to 4.2% (p < 0.001). CONCLUSION. When added to screening mammography, MBI performed using a radiopharmaceutical activity acceptable for screening (effective dose 2.4 mSv) yielded a supplemental cancer detection rate of 8.8 per 1000 women with mammographically dense breasts.

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OBJECTIVE: The standardized terminology and reporting structure of the BI-RADS for mammography, ultrasound, and MRI findings facilitates patient management. To date, no such terminology has been available for gamma camera breast imaging. We present an illustrated lexicon including description of background uptake, mass and nonmass uptake, lesion intensity, associated findings, and review of common artifacts. CONCLUSION: This proposed lexicon should facilitate standardized interpretation, communication of results, and outcomes monitoring of examinations using dedicated devices for gamma camera breast imaging.

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PURPOSE: Molecular breast imaging (MBI) has shown promise as an adjunct screening technique to mammography for women with dense breasts. The demonstration of reliable lesion detection with MBI performed at low administered doses of Tc-99 m sestamibi, comparable in effective radiation dose to screening mammography, is essential to adoption of MBI for screening. The concept of performing low-dose MBI with dual-head cadmium zinc telluride (CZT) gamma cameras has been investigated in phantoms in Part I. In this work, the objectives were to evaluate the impact of the count sensitivity improvement methods on image quality in patient MBI exams and to determine if adequate lesion detection could be achieved at reduced doses. METHODS: Following the implementation of two count sensitivity improvement methods, registered collimation optimized for near-field imaging and energy acceptance window optimized for CZT, MBI exams were performed in the course of clinical care. Clinical image count density (counts/cm(2)) was compared between standard MBI [740 MBq (20 mCi) Tc-99 m sestamibi, standard collimation, standard energy window] and low-dose MBI [296 MBq (8 mCi) Tc-99 m sestamibi, optimized collimation, wide energy window] in a cohort of 50 patients who had both types of MBI exams performed. Lesion detection at low doses was evaluated in a separate cohort of 32 patients, in which low-dose MBI was performed following 296 MBq injection and acquired in dynamic mode, allowing the generation of images acquired for 2.5, 5, 7.5, and 10 min/breast view with proportionately reduced count densities. Diagnostic accuracy at each count density level was compared and kappa statistic was used to assess intrareader agreement between 10 min acquisitions and those at shorter acquisition durations. RESULTS: In patient studies, low-dose MBI performed with 296 MBq Tc-99 m sestamibi and new optimal collimation/wide energy window resulted in an average relative gain in count density of 4.2 ± 1.3 compared to standard MBI performed with 740 MBq. Interpretation of low-dose 296 MBq images with count densities corresponding to acquisitions of 2.5, 5, 7.5, and 10 min/view and median lesion size of 1.4 cm resulted in similar diagnostic accuracy across count densities and substantial to near-perfect intrareader agreement between full 10 min-views and lower count density views. CONCLUSIONS: Review of patient studies showed that registered optimized collimation and wide energy window resulted in a substantial gain in count sensitivity as previously indicated by phantom results. This proof of concept work indicates that MBI performed at administered doses of 296 MBq Tc-99 m sestamibi with the applied count sensitivity improvements permits the detection of small breast lesions in patients. Findings suggest that further reductions in acquisition duration or administered dose may be achievable.

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PURPOSE OF THE REPORT: To report our findings from a prospective pilot study evaluating the accuracy of molecular breast imaging (MBI) in assessing tumor response to neoadjuvant therapy (NT) for breast cancer. MATERIALS AND METHODS: Twenty patients with newly diagnosed invasive breast cancer who were scheduled to receive NT underwent MBI before beginning and after completing NT before surgery. MBI was performed using a dual-detector cadmium-zinc-telluride gamma camera system mounted on a modified mammography gantry after patients had received an intravenous injection of 20 mCi of 99mTc sestamibi. Tumor extent was measured on MBI, and tumor-to-background (T/B) ratios of radiotracer uptake were determined through region-of-interest analysis. Pathologic measurement of tumor size was used as a standard and compared with post-NT tumor size derived from MBI. RESULTS: Three patients in whom post-NT MBI could not be performed because of scheduling problems were excluded from analysis. Eighteen cancers were diagnosed in 17 patients. A correlation coefficient of r = 0.681 (P = 0.002) was found between MBI and residual tumor size. The average T/B ratio on MBI decreased from a pretreatment value of 3.0 to a posttreatment value of 1.4. The relative decrease in T/B ratio did not appear to be predictive of response. CONCLUSIONS: Measurements of tumor size by MBI and T/B ratios are limited in their predictive value regarding the pathologic extent of residual disease in women treated with NT for breast cancer. Alternate tumor-specific radiopharmaceuticals should be evaluated to provide information to improve planning and monitoring of breast cancer treatment.

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PURPOSE: To determine interobserver agreement and diagnostic accuracy using a lexicon for standardized interpretation of molecular breast imaging (MBI) studies by breast radiologists. METHODS: An MBI lexicon was developed, including descriptors of lesion type, background uptake, and associated findings by a consensus of experts. In an institutional review board-exempted protocol, six breast imaging radiologist observers without prior MBI experience attended a 2-h MBI interpretation training session, including definitions of lexicon terminology, case examples, and ten unknown cases with expert feedback. Following training, each radiologist observer interpreted an independent set of MBI images of 50 breasts, including 20 (40%) with malignancies with a median invasive tumor size of 1.7 cm (range 1.0 to 6.3 cm). The findings were described using the lexicon and each breast was given a final assessment of 1 to 5, paralleling BI-RADS assessment categories. Sensitivity, specificity, positive and negative predictive values were determined with core or surgical pathology results or 1-year imaging follow-up as the reference standard. Interobserver agreement for lesion-type classification, lesion and background uptake intensity, and final assessments were determined using Cohen's kappa. RESULTS: For the six observers, median sensitivity was 1.0 (range 0.90-1.0), specificity 0.88 (range 0.83-0.97), and AUC 0.94 (range 0.93-0.98). Fair interobserver agreement was shown for background uptake (κ = 0.31). Agreement was substantial for lesion type (κ = 0.79) and non-mass distribution (κ = 0.63), and near-perfect for final assessment (κ = 0.84). CONCLUSION: Dedicated breast imaging radiologists, newly trained to interpret MBI with the proposed lexicon, achieved high agreement and diagnostic accuracy.

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