[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630155":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":34,"centralContacts":39,"locations":44,"responsibleParty":46,"collaborators":44,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":44,"enrollmentInfo":59,"targetDuration":44,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":72,"whyStopped":44,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":44},{"fullName":5,"class":6},"Franciscus Gasthuis & Vlietland (Hospital)","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients will be treated with ultrasound-guided percutaneous cryoablation","ACTIVE_COMPARATOR","Ultrasound-guided percutaneous cryoablation",[13],"Procedure: Percutaneous cryoablation",{"label":15,"type":6,"description":16,"interventionNames":17},"Breast-conserving surgery","Patients will be treated with breast-conserving surgery.",[18],"Procedure: Breast-conserving surgery",[20,29],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Percutaneous cryoablation","In this trial, the IceCure Prosense Cryoablation System will be used to execute the percutaneous cryoablation procedure.",[9],[26,27,28],"Minimally invasive treatment","Thermal ablation","Thermoablation",{"type":21,"name":15,"description":15,"armGroupLabels":30,"otherNames":31},[15],[32,33],"Lumpectomy","Lumpectomie",[35],{"name":36,"affiliation":37,"role":38},"T.M.A.L. GE Klem, MD, PhD","Franciscus Gasthuis & Vlietland","PRINCIPAL_INVESTIGATOR",[40],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Linda Riks, MD","CONTACT","010 - 893 6010",null,"l.riks@franciscus.nl",{"type":38,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"Linda Riks","MD","100630155","phase-3-cryoablation-versus-lumpectomy-in-early-stage-breast-cancer-100630155",false,"NCT07483996","Cryoablation Versus Lumpectomy in Early-Stage Breast Cancer","Cryoablation as Alternative for Lumpectomy in Early-Stage Breast Cancer: The CRYSTAL Trial","CRYSTAL","Inclusion Criteria:\n\n1. Women\n2. Age \\> 60 years\n3. Postmenopausal (no menstrual period for at least 12 months or in case of an intra-uterine device (IUD) hormone levels that indicate the menopause: follicle stimulating hormone (FSH) \\> 20 IE\u002Fl and estradiol \\\u003C 100 pmol\u002Fl)\n4. Histopathological confirmed primary invasive ER+\u002FHER2- type breast cancer\n5. Bloom Richardson grade 1 or 2 (low or intermediate malignancy grade)\n6. Unilateral and unifocal breast cancer\n7. A clinical T1N0M0 tumor (≤ 2cm and N0 on US and\u002For MRI), without distant metastases. The largest diameter measured will be used to determine eligibility.\n8. Tumor should be visible and well delineated (all borders of the tumor should be visible) on ultrasound at diagnosis and during the procedure.\n9. Sufficient knowledge of the Dutch language to complete the questionnaires\n10. To be able to give written informed consent\n\nExclusion Criteria:\n\n1. History of invasive breast cancer\n2. Breast augmentation\n3. BRCA-1 or 2 gene mutation carrier\n4. Lobular carcinoma\n5. Triple negative breast cancer\n6. Multifocality\n7. HER2-neu overexpressing tumors\n8. Lymph vascular invasion (LVI) on core needle biopsy or histopathological confirmed after lumpectomy\n9. Indication for neoadjuvant systemic therapy\n10. Intraductal component \\> 25% of the diameter of the invasive tumor on MRI, complete area of the primary tumor should not exceed 2cm.\n11. Allergic to local anesthetics\n12. Electrical devices and\u002For implants that are not compatible with MRI\n13. Current severe breast infection\n14. Uncorrectable coagulopathy\n15. Hemodynamic instability\n16. Respiratory instability\n17. Refraining from adjuvant radiotherapy\n18. Indication for oncoplastic surgery (surgical volume replacement techniques e.g. LICAP)","FEMALE","60 Years",{"count":60,"type":61},938,"ESTIMATED","INTERVENTIONAL",[64],"PHASE3","The goal of this randomised controlled trial is to compare ipsilateral breast cancer recurrence rates in patients with early-stage breast cancer between patients treated with breast conserving surgery and patient treated with percutaneous cryo-ablation.",[67],"Early-Stage Breast Cancer",[69,67,70,71],"Breast Cancer","Borstkanker","Vroegstadium Borstkanker","NOT_YET_RECRUITING","2026-03-16",{"date":75,"type":76},"2026-03-19","ACTUAL",{"date":78,"type":61},"2026-04-01",{"date":80,"type":61},"2038-12-31",{"name":5,"class":6}]