[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05825482":3,"trial-entities:NCT05825482":112,"trial-summary:NCT05825482":117},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":43,"secondary_outcomes":48,"sex":58,"minimum_age":59,"maximum_age":60,"healthy_volunteers":14,"eligibility_criteria":61,"std_ages":78,"locations":81,"central_contacts":103,"overall_officials":107,"references":110,"see_also_links":111},"NCT05825482","CASE5122","Breast Margin Study: Routine Cavity Shave Margins Vs. Selective Margins Using Savi Scout®","RECRUITING","2026-08","2026-04","2026-04-08","2023-07-17","Case Comprehensive Cancer Center","OTHER",false,"This is a prospective study comparing partial mastectomy performed with routine cavity shave margins and Savi Scout® localization to partial mastectomy performed with selective margins and Savi Scout® localization. The primary objective is to determine the difference in positive margin rate between the two methods. The secondary objectives are to determine the differences in the rate of re-excision, volume of tissue extracted and Breast-Q® score between the two methods. It is hypothesized that the Savi Scout® will allow for decreased volume of tissue excised when compared to routine cavity shave margins without any difference in positive margin rate or rate of re-excision.","Over a period of 24 months, this study will recruit 204 women 18 years and older with stage I-II breast cancer or stage 0 DCIS that have been diagnosed by core needle biopsy and are planning to receive breast conserving surgery.\n\nAfter obtaining consent, the patient will be asked to complete the Breast-Q® questionnaire which should take about 10-15 minutes for the patient to complete. The patient will then be randomized in a 1:1 fashion to:\n\nArm 1: Partial mastectomy with Savi Scout® localization and routine cavity shave margins\n\nArm 2: Partial mastectomy with Savi Scout® localization and selective shave margins.\n\nArm 1 and 2 patients will undergo preoperative Savi Scout® reflector placement under image guidance per routine care. The surgeons will be instructed to perform a partial mastectomy with routine cavity shave margins using Savi Scout® or partial mastectomy with selective margins using Savi Scout®. The lesion will be removed in the routine fashion. For patients in arm 1, the surgeons will use the Savi Scout® to perform routine cavity shave margins by extracting superior, lateral, inferior, medial, anterior, and posterior margins. For patients in arm 2, the Savi Scout® localizer will be utilized to determine selective shave margins by examining the same margins on the excised tissue specimen. The surgeon will obtain selective margins if the margin of the tissue specimen is within 1mm of invasive cancer and 2mm within DCIS. All surgeons participating in the study will undergo an educational session to ensure consistency.\n\nTissue specimens will be processed per hospital policy and sectioned for gross evaluation. Tissue specimens will be assessed by the pathologists at Cleveland Clinic Akron General. This simulates typical pathology review. Positive margin rate is a categorical variable and will be reviewed by pathology board certified physicians and thus should have minimal interpersonal variation.\n\nAt the postoperative visit, the patient will be asked to complete another Breast-Q® questionnaire.",[18],"Breast Cancer",[18,20,21,22,23],"Savi Scout","Shave margin","Selective margin","Breast-Q","INTERVENTIONAL","TREATMENT",[27],"NA",{"count":29,"type":30},204,"ESTIMATED",[32,38],{"type":33,"name":34,"description":35,"armGroupLabels":36},"PROCEDURE","Arm 1 Partial mastectomy with Savi Scout® localization and shave margins.","Patients will undergo preoperative Savi Scout® reflector placement under image guidance per routine care. Patients will undergo randomization. With Arm 1 randomization, the surgeons will be instructed to perform a partial mastectomy with routine cavity shave margins using Savi Scout® localization. The lesion will be removed in the routine fashion. The surgeons will use the Savi Scout® to perform routine cavity shave margins by extracting superior, lateral, inferior, medial, anterior, and posterior margins.",[37],"Arm 1",{"type":33,"name":39,"description":40,"armGroupLabels":41},"Arm 2 Partial mastectomy with Savi Scout® localization and selective shave margins.","Patients will undergo preoperative Savi Scout® reflector placement under image guidance per routine care. Patients will undergo randomization. With Arm 2 randomization, the surgeons will be instructed to perform a partial mastectomy with selective margins shave margins using Savi Scout®. The lesion will be removed in the routine fashion. The Savi Scout® localizer will be utilized to determine selective shave margins by examining the same margins on the excised tissue specimen. The surgeon will obtain selective margins if the margin of the tissue specimen is within 1mm of invasive cancer and 2mm within DCIS.",[42],"Arm 2",[44],{"measure":45,"description":46,"timeFrame":47},"Determine the difference in positive margin rate between the two methods.","The primary objective is to determine the difference in positive margin rate between the two methods.","24 months",[49,52,55],{"measure":50,"description":51,"timeFrame":47},"Difference in the rate of re-excision between the two methods.","Determine the difference in the rate of re-excision between the two methods.",{"measure":53,"description":54,"timeFrame":47},"Difference in the volume of tissue extracted between the two methods.","Determine the difference in the volume of tissue extracted between the two methods.",{"measure":56,"description":57,"timeFrame":47},"Difference in the BREAST-Q® Version 2.0 Breast Conserving Therapy Module Pre- and Postoperative Scales","Determine the difference in the Breast-Q® scores between the two methods. Scores range from 0 (worst) to 100 (best). Higher scores reflect a better outcome.","FEMALE","18 Years",null,{"inclusion":62,"exclusion":71,"raw_text":77},[63,64,65,66,67,68,69,70],"Women 18 years and older, and","With Clinical stage I-II invasive breast cancer, or Stage 0 DCIS, and","That have been diagnosed by means of core needle biopsy appropriate for breast conserving therapy, and","Present to Cleveland Clinic Akron General.","Subjects must have pathologically confirmed breast carcinoma or ductal carcinoma in situ.","Performance status: ECOG 0-1","Subjects must have the ability to understand and the willingness to sign a written informed consent document.","Patients may have received or may be receiving endocrine therapy.",[72,73,74,75,76],"Men","Pregnant women","Patients who have received neoadjuvant chemotherapy for current cancer diagnosis.","Patients with current diagnosis of synchronous bilateral breast cancer. (A diagnosis of breast cancer at least one year prior to current cancer diagnosis is acceptable.)","Patients \\\u003C 18 years of age.","Inclusion Criteria\n\n* Women 18 years and older, and\n* With Clinical stage I-II invasive breast cancer, or Stage 0 DCIS, and\n* That have been diagnosed by means of core needle biopsy appropriate for breast conserving therapy, and\n* Present to Cleveland Clinic Akron General.\n* Subjects must have pathologically confirmed breast carcinoma or ductal carcinoma in situ.\n* Performance status: ECOG 0-1\n* Subjects must have the ability to understand and the willingness to sign a written informed consent document.\n* Patients may have received or may be receiving endocrine therapy.\n\nExclusion Criteria\n\n* Men\n* Pregnant women\n* Patients who have received neoadjuvant chemotherapy for current cancer diagnosis.\n* Patients with current diagnosis of synchronous bilateral breast cancer. (A diagnosis of breast cancer at least one year prior to current cancer diagnosis is acceptable.)\n* Patients \\\u003C 18 years of age.",[79,80],"ADULT","OLDER_ADULT",[82],{"facility":83,"status":7,"city":84,"state":85,"zip":86,"country":87,"contacts":88,"geoPoint":100},"Cleveland Clinic Akron General, Case Comprehensive Cancer Center","Akron","Ohio","44302","United States",[89,94,97],{"name":90,"role":91,"phone":92,"email":93},"Michael McNeal, BSN","CONTACT","330-344-6348","mcnealm@ccf.org",{"name":95,"role":91,"phone":92,"email":96},"Wendy Catchpole, BS","catchpw@ccf.org",{"name":98,"role":99},"Andrew Fenton, MD","PRINCIPAL_INVESTIGATOR",{"lat":101,"lon":102},41.08144,-81.51901,[104],{"name":105,"role":91,"phone":106,"email":96},"Wendy Catchpole","3303446348",[108],{"name":109,"affiliation":83,"role":99},"Andrew Fenton, M.D.",[],[],{"nct_id":4,"conditions":113,"biomarkers":116},[114,115],"Breast Carcinoma","Breast Ductal Carcinoma In Situ",[],{"nct_id":4,"found":118,"summary":119,"prompt_version":129},true,{"design":120,"status":121,"heading":122,"summary":123,"follow_up":124,"word_count":125,"commitments":126,"compensation":127,"drugs_mentioned":128},"This is an interventional study comparing two surgical approaches using Savi Scout® localization, with 204 women expected to participate.","completed","Breast Margin Study: Savi Scout® for Breast Cancer Surgery","This study is for women aged 18 and older with early-stage breast cancer (Clinical stage I-II invasive breast cancer or Stage 0 DCIS) who are planning to have breast-conserving surgery. It compares two methods of removing breast cancer using a device called Savi Scout®. One method involves removing a routine amount of surrounding tissue (routine cavity shave margins), while the other removes tissue more selectively (selective shave margins). The main goal is to see if one method results in fewer positive margins (cancer cells found at the edge of the removed tissue) after 24 months. The study is also looking at how much tissue is removed and the need for additional surgeries. This study aims to enroll 204 participants.","The primary outcome of the study will be measured at 24 months after surgery.",119,"You would complete a questionnaire, have a Savi Scout® reflector placed, and undergo a partial mastectomy using one of the two methods being studied.","Not stated in the trial record.",[],"v2"]