Clinical trial · Interventional
Cryoablation Versus Lumpectomy in Early-Stage Breast Cancer
Cryoablation as Alternative for Lumpectomy in Early-Stage Breast Cancer: The CRYSTAL Trial
NCT07483996CI-TRIAL-00105989CRYSTALnot yet recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early-Stage Breast Cancer | Early Stage Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast-conserving surgery | Procedure | — | UNRESOLVED |
| Percutaneous cryoablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Patients will be treated with ultrasound-guided percutaneous cryoablation
- description
- Ultrasound-guided percutaneous cryoablation
- interventionNames
- Procedure: Percutaneous cryoablation
- type
- OTHER
- label
- Breast-conserving surgery
- description
- Patients will be treated with breast-conserving surgery.
- interventionNames
- Procedure: Breast-conserving surgery
Primary outcomes (1)
- measure
- Ipsilateral breast cancer recurrence
- timeFrame
- Until 5 years after the intervention
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women 2. Age \> 60 years 3. 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/l and estradiol \< 100 pmol/l) 4. Histopathological confirmed primary invasive ER+/HER2- type breast cancer 5. Bloom Richardson grade 1 or 2 (low or intermediate malignancy grade) 6. Unilateral and unifocal breast cancer 7. A clinical T1N0M0 tumor (≤ 2cm and N0 on US and/or MRI), without distant metastases. The largest diameter measured will be used to determine eligibility. 8. Tumor should be visible and well delineated (all borders of the tumor should be visible) on ultrasound at diagnosis and during the procedure. 9. Sufficient knowledge of the Dutch language to complete the questionnaires 10. To be able to give written informed consent Exclusion Criteria: 1. History of invasive breast cancer 2. Breast augmentation 3. BRCA-1 or 2 gene mutation carrier 4. Lobular carcinoma 5. Triple negative breast cancer 6. Multifocality 7. HER2-neu overexpressing tumors 8. Lymph vascular invasion (LVI) on core needle biopsy or histopathological confirmed after lumpectomy 9. Indication for neoadjuvant systemic therapy 10. Intraductal component \> 25% of the diameter of the invasive tumor on MRI, complete area of the primary tumor should not exceed 2cm. 11. Allergic to local anesthetics 12. Electrical devices and/or implants that are not compatible with MRI 13. Current severe breast infection 14. Uncorrectable coagulopathy 15. Hemodynamic instability 16. Respiratory instability 17. Refraining from adjuvant radiotherapy 18. Indication for oncoplastic surgery (surgical volume replacement techniques e.g. LICAP)
References
Publications (0)
Data not yet available
No reference posted for this study.