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Authors: Maria Luisa Machado Heredia1,2 Alphi Kuriakose1,2 Huma Javaid1,3 Brian Menegaz 1,3 Alastair Thompson1,2,3 Bora Lim1,2 Affiliation 1Dan L. Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX 77030 2 Lester and Sue Smith Breast Center, Baylor College of Medicine, Houston, TX 77030 3 Department of Surgery, Baylor College of Medicine, Houston, TX 77030 Background and Purpose Increasing research data support the existence of barriers and discrepancies to oncology interventional clinical trial enrollment rate based on patients’ social-economic status. However, few studies examined if such discrepancy exists in observational trials. We hypothesize the enrollment discrepancy remains the same in specimen collection only protocols, and several factors including health literacy and religious belief contribute to such discrepancy. Methods Data was collected from March 1st, 2022, to July 7th, 2022, as part of an ongoing pilot study examining circulating tumor DNA (ctDNA) from patients diagnosed with stage IV metastatic breast cancer starting a new line of therapy treatment (BCM protocol number H- 48751). This study was selected as specimen collected is part of normally scheduled standard of care clinical labs and beyond informed consent does not require any additional patient commitment for participation. This study was performed across both county and private practice sites:1) Smith Clinic-Harris Health System 2) Baylor Saint Luke’s Medical center (BSLMC); respectively. Correlations for independent variables potentially affecting enrollment were assessed to estimate the association between patient participation and socio-economic factors like religious affiliation and level of formal education received. Free-form text responses were collected from patients who declined study participation. Results Fourteen eligible candidates were asked to participate in the observational trial to determine whether serial changes in ctDNA ratio correlate with the results of first monitoring patients via imaging at three months. Out of 14 patients approached, 5 patients (36%) declined. Interestingly, all five patients who declined were from Smith Clinic- Harris Health System, while all BSLMC patients agreed to enroll. Based on the free-text response of why patients declined the ctDNA study, we identified a total of 4 different categories: Language barriers, low health literacy, religious objection, and disinterest in research. Using these four categories, we continue to collect data to improve our understanding of barriers in observational trial enrollment. Conclusion Low literacy and other socioeconomic factors serve as barriers to enrollment in observational trials for patients who suffer from stage IV breast cancers. In our preliminary data, we also noted that these barriers are only relevant for patients who are treated at the county hospital. An investigation to recognize low literacy and religious affiliation as barriers to poor trial accrual is ongoing. Reasons to declining participation in observational trial. Citation Format: Maria L. Machado Heredia, Alphi Kuriakose, Brian A. Menegaz, Alastair M. Thompson, Bora Lim, Huma Javaid. Barriers to enrolling in observational trials for patients with stage IV breast cancer. [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P6-08-03.

Background/Purpose: Superparamagnetic iron oxide (SPIO)-based techniques like Magseed and Magtrace offer alternatives for breast lesion and sentinel lymph node (SNL) localization. Magseeds placed under ultrasound guidance offer logistical and safety advantages compared to traditional wire-localization or radioactive seed placement. Further, Magtrace injection is a viable SNL-localization alternative that overcomes radiation safety, skin necrosis, and allergic reactions associated with traditional 99mTc colloid and Methylene blue/Isosulfan blue dyes. To evaluate the effectiveness of these techniques in surgical practice, we report the implementation of Magseed and Magtrace at Baylor St. Luke’s Medical Center. Methods: We retrospectively reviewed prospectively collected data from the 128 female patients undergoing Magseed/Magtrace procedures from October 2019 to December 2020. Demographics and clinical characteristics were summarized, and surgical outcomes analyzed including margin status, re-excision rates, post-operative breast and axilla complications, successful localization and detection rates. Results: Patients presented with varied diagnoses including 98 (77%) with invasive carcinoma, 21 (16%) with DCIS, and 9 (7%) with fibroadenoma, papillary, or other lesions. 50 patients (39%) underwent neoadjuvant therapy. Mean BMI at surgery was 27.33 kg/m2 (range, 17.80-48.65) and mean age was 57.26 years (range, 27-86). Breast density varied, 5 (4%) categorized as almost entirely fatty, 69 (54%) as heterogeneously dense, 12 (9%) as extremely dense, and 39 (30%) with fibroglandular density. For breast size there were 2 (2%) A cups, 13 (10%) B cups, 16 (13%) C cups, 10 (8%) D cups, 8 (6%) DD cups, 2 (2%) DDD cups, 1 (.8%) F cup, and 12 (9%) with in between breast size (A-DDD). 108 patients (84%) had on-table Magtrace injection and 52 (41%) had Magseed localization. 18 (14%) patients had Methylene blue/Isosulfan blue dye or Technetium-99 used with Magseed and/or Magtrace. There was a 100% (52/52) success rate of lesion localization using Magseed and a 94% (101/108) success rate of SLN detection using Magtrace. Magtrace brown skin staining occurred in 12/108 patients (11%). Breast complications occurred in 43 patients (34%), with bruising/hematoma in 30/43 (70%), seroma in 7/43 (16%), and infection in 4/43 (9%). Axilla complications occurred in 11 patients (9%): 5/11 (45%) had bruising/hematoma, 6/11 (55%) had seroma, and 1/11 (9%) had infection. Positive margins were seen in 11 (9%) patients with re-excision performed in 8 women (6%). Conclusions: Magseed and Magtrace are comparable to standard practices in terms of practicality, surgical implementation, and risk of surgical complications and re-excision, providing a rationale for the adoption of SPIO-based techniques. By putting these surgical techniques into practice and evaluating their success in excising a wide range of lesions and monitoring complications, there is possibility of introducing new, innovative techniques into a standardized clinical setting within surgical oncology. Magseed/Magtrace Procedures at BSLMCRaw NumberPercentageTechniquesMagtrace Only6047%Magseed Only1915%Magtrace + Magseed3124%Isotope1713%Blue Dye11%Skin Staining Post-Op.1211%Breast Complication4334%Wound Complication921%Infection49%Bruising/Hematoma3070%Seroma716%Patients with >1 complication49%Axilla Complication119%Wound Complication00%Infection19%Bruising/Hematoma545%Seroma655%Patients with >1 complication19%Re-excision Rate86%Histological TypesER+, HER2-7055%ER+10078%HER2+2016%TNB1310% Citation Format: Jessica Montalvan, Logan Healy, Huma Javaid, Ivan Marin, Brian Menegaz, Cary Hsu, Eric Silberfein, Elizabeth Bonefas, Stacey Carter, Alastair Thompson. Magseed/magtrace-guided surgery in breast cancer- an institutional perspective [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P3-20-06.

Background: Ensuring negative margins at the time of breast conserving surgery for invasive breast cancer or ductal carcinoma in situ is necessary to minimize the chance of local recurrence and avoid re-excisions that cause patient concern and may delay adjuvant therapy. However, about 25% of women who have lumpectomy have a second surgery to remove residual disease, suggesting an ongoing need for improved methods of intraoperative margin assessment. This study aimed to perform a contemporary review of methods of intraoperative margin assessment during breast conservation surgery. Methods: A review of the scientific literature from 2009 to 2021 comprising 62 manuscripts of the current and proposed. intraoperative techniques for breast margin assessment during breast conservation surgery was conducted via PubMed and Google Scholar. The methods assessed were grouped into 10 categories based on the technology employed: bioimpedance/radiofrequency, high-resolution imaging, optical imaging, mass spectrometry, magnetic-resonance imaging, 2D/3D specimen CT, X-ray, multimodal optical microscopy, pharmacologic and pathological margin assessment. All technologies were reviewed for overall effectiveness in lowering re-excision rates derived from their respective advantages, limitations, sensitivity, and specificity. Results: Overall, 8 current and 7 technologies under development were assessed (Table 1). Frozen section and cytology yielded the highest diagnostic accuracy; however, these can be time-consuming, resource-intensive, and have limited sampling points. Conversely, 2D specimen CT provides rapid results but is limited by relatively low sensitivity. Future technologies such as optical coherence tomography showed promising results in demonstrating higher diagnostic accuracy for lumpectomy and margin shaves, but remain to be proven in clinical practice. Conclusion: Intraoperative margin assessments can lower final positive margins and subsequent re-excisions rates. A number of current and upcoming technologies that assess margin status range in their respective efficacies and limitations. There remains demand for improved margin assessment at the time of breast conserving surgery, but which technologies will become standard of care remains, at present, unclear. Table 1.Methods of intraoperative margin assessmentMethod:Brand:Sensitivity:Specificity:Source:Bioimpedence• ClearEdge™87.3%75.6%Dixon et al. 2016• MarginProbe75.2%70-87%Schanabel et al., 2014Cytology:• Imprint72%97%Esbona & Zhanhai 2012; Qui et al., 2018Frozen Section–83%95%Schmidt et al, 2020; Schwarz & Schmidt, 2020Mass Spectrometry• iKnife93.4-94.7%94.7-96.2%St. John et al., 2017• MasSpec Pen83-95%95-100%Garza et al., 2020Multimodal optical microscopy• fluorescence imaging combination withRCM/OCT subsystemTBDTBDScimone et al., 2021MRI• ClearSight™93%92%Moshe et al., 2016Optical Coherence Tomography (OCT)• OTIS™96%92%Mojahed et al., 2020; Schmidt et al. 2020Pharmacology• Bevacizumab98%79%Koch et al., 2017• Lumicell2-3D specimen CT• Mozart®93%78%Black et al., [poster]• Faxitron78.6-85.6%100%Emmadi & Wiley 2012; Bathla et al. 2011• MicroCT56%100%Qiu et al. 2018X-ray• XPCI83%83%Massimi et al. 2021 Citation Format: Huma Javaid, Ivan Marin, Jessica Montalvan, Logan Healy, Brian Menegaz, Cary Hsu, Eric Silberfein, Elizabeth Bonefas, Stacey A. Carter, Alastair M. Thompson. Current options and future perspectives for breast margin assessment in clinical practice [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P3-18-10.