[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100478105":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":39,"centralContacts":43,"locations":48,"responsibleParty":82,"collaborators":84,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":92,"sex":98,"minAge":99,"maxAge":34,"enrollmentInfo":100,"targetDuration":34,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":110,"overallStatus":50,"whyStopped":34,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Washington University School of Medicine","OTHER",[8,14,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Cryoablation","EXPERIMENTAL","Patients will be treated with cryoablation using the Endocare SlimLine Cyroprobe under real time ultrasound guidance and local anesthesia. The cryoablation consists of a 10 minute freeze phase followed by a 10 minute passive thaw, and ends with a second 10 minute freeze cycle. The freeze-thaw-freeze times may be adjusted at the physician's discretion depending on tumor size.",[13],"Device: Endocare SlimLine Cryoprobe",{"label":15,"type":16,"description":17,"interventionNames":18},"Lumpectomy","ACTIVE_COMPARATOR","Lumpectomy will be performed under general anesthesia as per standard operative procedures at Washington University and Siteman Cancer Center.",[19],"Procedure: Lumpectomy",{"label":21,"type":6,"description":22,"interventionNames":23},"Rescue Arm: Lumpectomy","If there is evidence of residual or recurrent tumor on follow-up imaging evaluation (6 month MRI (if can tolerate) and yearly MRI\u002Fmammography), patients in the cryoablation safety lead-in and who were randomized to receive cryoablation only will be crossed over to receive a rescue lumpectomy followed by adjuvant treatment based on standard of care.",[19],{"label":25,"type":10,"description":26,"interventionNames":27},"Cryoablation - Safety Lead In","Patients will be treated with cryoablation (Day 1) using the Endocare SlimLine Cyroprobe followed by adjuvant treatment.",[13],[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DEVICE","Endocare SlimLine Cryoprobe","The Endocare(TM) SlimLine (TM) Cryoprobe is a single use, disposable device designed for use with Endocare Cryocare Surgical Systems. Endocare cryoprobes are designed to deliver cold temperatures for cryoablation using high-pressure argon gas circulated through the cryoprobe, followed by active thawing using helium gas.\n\nThe Cryocare CS Surgical System is intended for use in open, minimally invasive, or endoscopic surgical procedures in the areas of general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery, and thoracic surgery. The system is designed to freeze\u002Fablate tissue by the application of extreme cold temperatures.",[9,25],null,{"type":36,"name":15,"description":37,"armGroupLabels":38,"otherNames":34},"PROCEDURE","Patients randomized to cryoablation who experience disease recurrence may undergo crossover to lumpectomy.",[15,21],[40],{"name":41,"affiliation":5,"role":42},"Heather Garrett, M.D.","PRINCIPAL_INVESTIGATOR",[44],{"name":41,"role":45,"phone":46,"phoneExt":34,"email":47},"CONTACT","636-916-9662","hvgarrett@wustl.edu",[49],{"facility":5,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"RECRUITING","St Louis","Missouri","63110","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-90.19789,38.62727,{"lat":60,"lon":59},[63,64,65,68,70,72,74,76,78,80],{"name":41,"role":45,"phone":46,"phoneExt":34,"email":47},{"name":41,"role":42,"phone":34,"phoneExt":34,"email":34},{"name":66,"role":67,"phone":34,"phoneExt":34,"email":34},"Robert McKinstry, M.D.","SUB_INVESTIGATOR",{"name":69,"role":67,"phone":34,"phoneExt":34,"email":34},"Debbie Bennett, M.D.",{"name":71,"role":67,"phone":34,"phoneExt":34,"email":34},"Julie Margenthaler, M.D.",{"name":73,"role":67,"phone":34,"phoneExt":34,"email":34},"Katherine Clifton, M.D.",{"name":75,"role":67,"phone":34,"phoneExt":34,"email":34},"Jingqin Luo, Ph.D.",{"name":77,"role":67,"phone":34,"phoneExt":34,"email":34},"Christina Doherty, M.D.",{"name":79,"role":67,"phone":34,"phoneExt":34,"email":34},"Tabassum Ahmad, M.D.",{"name":81,"role":67,"phone":34,"phoneExt":34,"email":34},"Imran Zoberi, M.D.",{"type":83,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[85,87],{"name":86,"class":6},"The Foundation for Barnes-Jewish Hospital",{"name":88,"class":89},"Varian Medical Systems","INDUSTRY","100478105","cryoablation-vs-lumpectomy-in-t1-breast-cancers-100478105",false,"NCT05505643","Cryoablation vs Lumpectomy in T1 Breast Cancers","COOL-IT: Cryoablation vs Lumpectomy in T1 Breast Cancers: A Randomized Controlled Trial With Safety Lead-in","COOL-IT","Inclusion Criteria:\n\n* Diagnosis of invasive ductal carcinoma of the breast (ER , Her-2 negative) that is grade 1 or 2 with intraductal component \\\u003C25%. Must be T1N0M0 (2 cm or less).\n* If DCIS is present in the biopsy specimen it should be \\\u003C25% of the tumor and should be contiguous with the IDC. (i.e. DCIS should not be a separate tumor from the IDC).\n* Oncotyping will be performed on T1b+Allred\\\u003C6\u002F8 and T1c tumors. Oncotype score in this subset of patients must be \\\u003C26 to be included in the trial.\n* At least 50 years of age.\n* Negative ipsilateral axillary assessment as determined either by (1) negative axillary ultrasound (2) negative sentinel lymph node biopsy or (3) negative percutaneous axillary node biopsy with no further clinical or imaging concern for nodal metastatic disease.\n* Able to understand and willing to sign an IRB-approved written informed consent document.\n\nExclusion Criteria:\n\n* Indication for neoadjuvant chemotherapy.\n* Prior history of breast cancer.\n* Breast augmentation.\n* Allergy to local anesthetics.\n* Pregnant or lactating. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.\n* Tumoral involvement of skin or chest wall.","FEMALE","50 Years",{"count":101,"type":102},120,"ESTIMATED","INTERVENTIONAL",[105],"NA","This trial studies the efficacy and safety of cryoablation in patients with low risk, early stage breast cancer. Cryoablation is a method of killing a tumor by freezing it. The standard approach for patients with this kind of cancer is a lumpectomy. This study will review the safety of the cryoablation procedure initially, followed by comparing cryoablation to lumpectomy in order to see if the cryoablation results in better disease control, complication rates, and quality of life.",[108,109],"Breast Cancer","Breast Neoplasm",[111,112,113],"breast cancer","cryoablation","lumpectomy","2026-02-24",{"date":116,"type":117},"2026-02-27","ACTUAL",{"date":119,"type":117},"2024-04-03",{"date":121,"type":102},"2033-04-30",{"name":5,"class":6},1]