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Radiofrequency Ablation (RFA) in Breast Tumors (RFA)

Primary Purpose

Breast Cancer Female

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Cool-tip electrode for Radiofrequency Ablation
Sponsored by
Hospital Universitari de Bellvitge
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer Female focused on measuring radiofrequency, early stage

Eligibility Criteria

65 Years - undefined (Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Sites / Locations

  • Hospital de BellvitgeRecruiting
  • Hospital del MarRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiofrequency

Arm Description

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

Outcomes

Primary Outcome Measures

MRI post-RFA
Magnetic Resonance Image after Radiofrequency ablation to confirmate complete disappearance of tumor contrast enhancement.
BAG post-RFA
Breast biopsy after Radiofrequency to confirmate absence of viable tumor tissue using NADH, CK18 and CK19 stainings.

Secondary Outcome Measures

Adverse Effects
Adverse effects related to radiofrequency
Quality
Breast-Q

Full Information

First Posted
May 3, 2020
Last Updated
February 28, 2023
Sponsor
Hospital Universitari de Bellvitge
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1. Study Identification

Unique Protocol Identification Number
NCT04389216
Brief Title
Radiofrequency Ablation (RFA) in Breast Tumors
Acronym
RFA
Official Title
Radiofrequency Ablation in Breast Tumors in Early Stages
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
December 15, 2024 (Anticipated)
Study Completion Date
December 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitari de Bellvitge

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To validate the efficacy and safety of the cool-tip ablation method for breast tumors smaller than 2 cm.
Detailed Description
A prospective, phase II-III study, which will include a series of cases of 30 patients. The hospitals involved will be Bellvitge University Hospital and Hospital del Mar. Efficacy was evaluated according magnetic resonance image and biopsy of the breast 1 month after the procedure. Patients will be followed up over a 2-year period to assess cosmetic results, short and long-term complications and possible recurrences.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female
Keywords
radiofrequency, early stage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Radiofrequency ablation
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiofrequency
Arm Type
Experimental
Arm Description
Radiofrequency Ablation of breast cancer tumour by Cool-tip electrode.
Intervention Type
Device
Intervention Name(s)
Cool-tip electrode for Radiofrequency Ablation
Intervention Description
Radiofrequency ablation of the tumour in the surgery group, associated whith axillary surgery when applicable
Primary Outcome Measure Information:
Title
MRI post-RFA
Description
Magnetic Resonance Image after Radiofrequency ablation to confirmate complete disappearance of tumor contrast enhancement.
Time Frame
1 month after procedure
Title
BAG post-RFA
Description
Breast biopsy after Radiofrequency to confirmate absence of viable tumor tissue using NADH, CK18 and CK19 stainings.
Time Frame
1 month after procedure
Secondary Outcome Measure Information:
Title
Adverse Effects
Description
Adverse effects related to radiofrequency
Time Frame
Through study completion, an average of 1 year
Title
Quality
Description
Breast-Q
Time Frame
1 month after procedure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Personal antecedents of breast cancer Multifocality or intraductal carcinoma Lobular infiltrating carcinoma Neoadjuvant therapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amparo Garcia-Tejedor, MDPhD
Phone
660223417
Email
agarciat@bellvitgehospital.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amparo Garcia-Tejedor, MDPhD
Organizational Affiliation
Hospital Universitari Bellvitge
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Bellvitge
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amparo Garcia-Tejedor, MDPhD
Phone
0034-660223417
Email
agarciat@bellvitgehospital.cat
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nuria Argudo, MD
Email
nargudo@parcdesalutmar.cat

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Radiofrequency Ablation (RFA) in Breast Tumors

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