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Clinical Trial NCT07483996 (CRYSTAL) for Early-Stage Breast Cancer is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Cryoablation Versus Lumpectomy in Early-Stage Breast Cancer (CRYSTAL) Phase 3 938

Not yet recruiting
Clinical Trial NCT07483996 (CRYSTAL) is designed to study Treatment for Early-Stage Breast Cancer. This Phase 3 interventional study is not yet recruiting. Enrollment is planned to begin on 1 April 2026 until the study accrues 938 participants. Led by Franciscus Gasthuis & Vlietland (Hospital), this study is expected to complete by 31 December 2038. The latest data from ClinicalTrials.gov was last updated on 19 March 2026.
Brief Summary
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.
Official Title

Cryoablation as Alternative for Lumpectomy in Early-Stage Breast Cancer: The CRYSTAL Trial

Conditions
Early-Stage Breast Cancer
Other Study IDs
  • CRYSTAL
  • NL-010714
NCT ID Number
NCT07483996
Start Date (Actual)
2026-04-01
Last Update Posted
2026-03-19
Completion Date (Estimated)
2038-12-31
Enrollment (Estimated)
938
Study Type
Interventional
PHASE
Phase 3
Status
Not yet recruiting
Keywords
Breast Cancer
Early-Stage Breast Cancer
Borstkanker
Vroegstadium Borstkanker
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorPatients will be treated with ultrasound-guided percutaneous cryoablation
Ultrasound-guided percutaneous cryoablation
Percutaneous cryoablation
In this trial, the IceCure Prosense Cryoablation System will be used to execute the percutaneous cryoablation procedure.
OtherBreast-conserving surgery
Patients will be treated with breast-conserving surgery.
Breast-conserving surgery
Breast-conserving surgery
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Ipsilateral breast cancer recurrence
Proportion of ipsilateral breast cancer recurrences (IBTR) after 5 years in both study arms.
Until 5 years after the intervention
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Complication Rate
The proportion of complications within 30 days (percentage Clavien-Dindo classification).
Within 30 days after the intervention
Regional breast cancer recurrences
Regional breast cancer recurrences, defined as clinically, radiologically, and/or histologically confirmed recurrence in regional lymph nodes.
Until 5 years after the intervention
Disease Free Survival
Disease free survival (DFS) is defined as the time from date of intervention to the first occurrence of recurrent disease of the same histological characteristics as the primary tumor and in the same quadrant as the primary tumor
until 15 years after the intervention
Overall Survival
Overall survival (OS) is defined as the time from breast cancer diagnosis to death from any cause.
through study completion, an average of 15 years
Cosmetic Outcomes
o assess cosmetic outcomes following treatment with cryoablation or lumpectomy using the BCTOS-13 and BREAST-Q questionnaires at specified follow-up visits, and objective assessment using BCCT.core software. Higher scores indicate better cosmetic outcomes.
at baseline, 6 months and 1 year after the intervention
Hospital-related costs
Hospital-related costs, including expenses made due to additional findings on inclusion MRI
Until 5 years after the intervention
Out-of-hospital (non)-medical costs
To assess out-of-hospital medical and non-medical costs and productivity losses using the iMTA Medical Consumption Questionnaire (iMCQ) and iMTA Productivity Cost Questionnaire (iPCQ) questionnaires.
Until 5 years after the intervention
Generic Health-related Quality of Life
To assess general health-related quality of life using the EQ-5D-5L questionnaire, with higher scores indicating better health status
At baseline, 6 months after the intervention, 1 and 5 years after the intervention
Disease-specific quality of life
To assess cancer-specific quality of life using the EORTC QLQ-C30 and EORTC QLQ-BR23 questionnaires. Higher scores indicate better functioning or greater symptom burden depending on the subscale.
At baseline, 6 months after the intervention, 1 and 5 years after the intervention
Complete ablation rate
On magnetic resonance imaging
2 weeks after the intervention (cryoablation)
Predictive value of MRI
The negative predictive-, and diagnostic value of MRI for incomplete ablation
until 5 years after the intervention
Proportion of reinterventions
For both study arms.
For the duration of the study, most likely within 2 weeks after the intervention
Radiation Toxicity
The proportion of acute and long-term breast irradiation toxicity (radiation dermatitis, superficial or deep connective tissue fibrosis, chest wall pain, localized edema) using common toxicity criteria (CTCAE v5.0) and cosmetic questionnaires
At baseline, prior to radiation, 1 year and 5 years after the intervention
Incremental cost-utility ratio (ICUR)
To estimate the incremental cost-utility ratio (ICUR). Higher ICUR values indicate higher costs per quality-adjusted life year (QALY) gained.
Until 5 years after the intervention
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
60 Years
Eligible Sexes
Female
  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

  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)
Franciscus Gasthuis & Vlietland (Hospital) logoFranciscus Gasthuis & Vlietland (Hospital)
Study Responsible Party
Linda Riks, Principal Investigator, MD, Franciscus Gasthuis & Vlietland (Hospital)
Study Central Contact
Contact: Linda Riks, MD, 010 - 893 6010, [email protected]
No location data.