NCT04389216

Brief Summary

To validate the efficacy and safety of the cool-tip ablation method for breast tumors smaller than 2 cm.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 15, 2020

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2025

Completed
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

5.4 years

First QC Date

May 3, 2020

Last Update Submit

September 8, 2025

Conditions

Breast Cancer Female

Keywords

radiofrequencyearly stage

Outcome Measures

Primary Outcomes (2)

  • MRI post-RFA

    Magnetic Resonance Image after Radiofrequency ablation to confirmate complete disappearance of tumor contrast enhancement (residual mm).

    "1 month"

  • BAG post-RFA

    Breast biopsy after Radiofrequency to confirmate absence of viable tumor tissue using NADH, CK18 and CK19 stainings (tumor viability scale: 0, \<25%, 25-50%, 50-75%, \> 75%).

    "1 month"

Secondary Outcomes (2)

  • Adverse Effects

    "1 month"

  • Quality

    "1 month"

Study Arms (1)

Radiofrequency Ablation Tumor

EXPERIMENTAL

Radiofrequency Ablation of breast cancer tumour by Cool-tip electrode.

Device: Cool-tip electrode for Radiofrequency Ablation

Interventions

Cool-tip electrode for Radiofrequency AblationDEVICE

Radiofrequency ablation of the tumour in the surgery group, associated whith axillary surgery when applicable

Radiofrequency Ablation Tumor

Eligibility Criteria

Age65 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Infiltrating ductal carcinoma according the biopsy of the breast,
  • Tumor visible by ultrasound, smaller than 2 cm,
  • Located \> 1 cm from the chest wall and the skin.

You may not qualify if:

  • Personal antecedents of breast cancer
  • Multifocality or intraductal carcinoma
  • Lobular infiltrating carcinoma
  • Neoadjuvant therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

Hospital de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

MeSH Terms

Interventions

Radiofrequency Ablation

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Amparo Garcia-Tejedor, MDPhD

    Hospital Universitari Bellvitge

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Radiofrequency ablation
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PRINCIPAL INVESTIGATOR

Study Record Dates

First Submitted

May 3, 2020

First Posted

May 15, 2020

Study Start

May 1, 2020

Primary Completion

September 9, 2025

Study Completion

September 9, 2025

Last Updated

September 15, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)