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Early-Stage Breast CancerPhase 3CRYSTALNCT07483996

Cryoablation Versus Lumpectomy in Early-Stage Breast Cancer

A Phase 3 study testing Percutaneous cryoablation and Breast-conserving surgery in people with Early-Stage Breast Cancer, run by Franciscus Gasthuis & Vlietland (Hospital).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and older, women only
Conditions the study is for
Early-Stage Breast Cancer
What is being tested?
Percutaneous cryoablation and Breast-conserving surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
938 participants
Where
No sites listed yet
Study dates
1 Apr 2026to 31 Dec 2038
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Women
  • Age > 60 years
  • 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)
  • Histopathological confirmed primary invasive ER+/HER2- type breast cancer
  • Bloom Richardson grade 1 or 2 (low or intermediate malignancy grade)
  • Unilateral and unifocal breast cancer
Show all 10Show fewer
  • 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.
  • Tumor should be visible and well delineated (all borders of the tumor should be visible) on ultrasound at diagnosis and during the procedure.
  • Sufficient knowledge of the Dutch language to complete the questionnaires
  • To be able to give written informed consent

Who cannot join

  • History of invasive breast cancer
  • Breast augmentation
  • BRCA-1 or 2 gene mutation carrier
  • Lobular carcinoma
  • Triple negative breast cancer
  • Multifocality
Show all 18Show fewer
  • HER2-neu overexpressing tumors
  • Lymph vascular invasion (LVI) on core needle biopsy or histopathological confirmed after lumpectomy
  • Indication for neoadjuvant systemic therapy
  • Intraductal component > 25% of the diameter of the invasive tumor on MRI, complete area of the primary tumor should not exceed 2cm.
  • Allergic to local anesthetics
  • Electrical devices and/or implants that are not compatible with MRI
  • Current severe breast infection
  • Uncorrectable coagulopathy
  • Hemodynamic instability
  • Respiratory instability
  • Refraining from adjuvant radiotherapy
  • Indication for oncoplastic surgery (surgical volume replacement techniques e.g. LICAP)

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Linda Riks, MD contact

010 - 893 6010

l.riks@franciscus.nl

About this study

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

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.

Being tested
Percutaneous cryoablation, Breast-conserving surgery
Keywords
Breast Cancer, Early-Stage Breast Cancer, Borstkanker, Vroegstadium Borstkanker
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous cryoablationProcedure or surgery

    Also called Minimally invasive treatment, Thermal ablation, Thermoablation

    In this trial, the IceCure Prosense Cryoablation System will be used to execute the percutaneous cryoablation procedure.

  • Breast-conserving surgeryProcedure or surgery

    Also called Lumpectomy, Lumpectomie

    Breast-conserving surgery

Study groups in NCT07483996
Study groupRoleWhat they receive
Patients will be treated with ultrasound-guided percutaneous cryoablationActive comparatorUltrasound-guided percutaneous cryoablation
Receives: Procedure: Percutaneous cryoablation
Breast-conserving surgeryOtherPatients will be treated with breast-conserving surgery.
Receives: Procedure: Breast-conserving surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ipsilateral breast cancer recurrence

    Proportion of ipsilateral breast cancer recurrences (IBTR) after 5 years in both study arms.

    Measured: Until 5 years after the intervention

Secondary outcomes (14)

  1. Complication Rate

    The proportion of complications within 30 days (percentage Clavien-Dindo classification).

    Measured: Within 30 days after the intervention

  2. Regional breast cancer recurrences

    Regional breast cancer recurrences, defined as clinically, radiologically, and/or histologically confirmed recurrence in regional lymph nodes.

    Measured: Until 5 years after the intervention

  3. 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

    Measured: until 15 years after the intervention

  4. Overall Survival

    Overall survival (OS) is defined as the time from breast cancer diagnosis to death from any cause.

    Measured: through study completion, an average of 15 years

  5. Cosmetic Outcomes

    • 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.

    Measured: at baseline, 6 months and 1 year after the intervention

  6. Hospital-related costs

    Hospital-related costs, including expenses made due to additional findings on inclusion MRI

    Measured: Until 5 years after the intervention

  7. 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.

    Measured: Until 5 years after the intervention

  8. 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

    Measured: At baseline, 6 months after the intervention, 1 and 5 years after the intervention

  9. 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.

    Measured: At baseline, 6 months after the intervention, 1 and 5 years after the intervention

  10. Complete ablation rate

    On magnetic resonance imaging

    Measured: 2 weeks after the intervention (cryoablation)

  11. Predictive value of MRI

    The negative predictive-, and diagnostic value of MRI for incomplete ablation

    Measured: until 5 years after the intervention

  12. Proportion of reinterventions

    For both study arms.

    Measured: For the duration of the study, most likely within 2 weeks after the intervention

  13. 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

    Measured: At baseline, prior to radiation, 1 year and 5 years after the intervention

  14. 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.

    Measured: Until 5 years after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2026
  2. Study start1 Apr 2026 (estimated)
  3. Primary completion31 Dec 2035 (estimated)
  4. Study completion31 Dec 2038 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
This is a multicenter randomized phase III non-inferiority trial with two arms: percutaneous cryoablation and breastconserving surgery. The randomization ratio is 1:1, stratified by center, tumor size (\< / \> 1 cm) and Bloom Richardson grade. All eligible patients will consecutively be included and randomized. Crossover is only possible for patients allocated to the cryoablation arm.
Masking
None (open label)
Enrolment
938 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07483996
Sponsor's protocol ID
NL-010714
Acronym
CRYSTAL
Status last verified
Mar 2026
First submitted
11 Mar 2026
Last updated
19 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Percutaneous cryoablation and Breast-conserving surgery in people with Early-Stage Breast Cancer, run by Franciscus Gasthuis & Vlietland (Hospital).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Linda Riks, MD (010 - 893 6010, l.riks@franciscus.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ipsilateral breast cancer recurrence (time frame: Until 5 years after the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07483996.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.

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