Breast Cancer FemaleRFANCT04389216
Radiofrequency Ablation (RFA) in Breast Tumors
A study testing Cool-tip electrode for Radiofrequency Ablation in people with Breast Cancer Female, run by Hospital Universitari de Bellvitge at 2 sites in Spain.
Trial summary
To validate the efficacy and safety of the cool-tip ablation method for breast tumors smaller than 2 cm. Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Cool-tip electrode for Radiofrequency Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesSpain
- Study dates
- 1 May 2020to 9 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- Personal antecedents of breast cancer
- Multifocality or intraductal carcinoma
- Lobular infiltrating carcinoma
- Neoadjuvant therapy
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital del Mar
Barcelona, Barcelona, 08003
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
About this study
Official title: Radiofrequency Ablation in Breast Tumors in Early Stages
To validate the efficacy and safety of the cool-tip ablation method for breast tumors smaller than 2 cm.
Read the 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.
- Conditions
- Breast Cancer Female
- Being tested
- Cool-tip electrode for Radiofrequency Ablation
- Keywords
- radiofrequency, early stage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cool-tip electrode for Radiofrequency AblationDevice
Radiofrequency ablation of the tumour in the surgery group, associated whith axillary surgery when applicable
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency Ablation Tumor | Experimental | Radiofrequency Ablation of breast cancer tumour by Cool-tip electrode. Receives: Device: Cool-tip electrode for Radiofrequency Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI post-RFA
Magnetic Resonance Image after Radiofrequency ablation to confirmate complete disappearance of tumor contrast enhancement (residual mm).
Measured: "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%).
Measured: "1 month"
Secondary outcomes (2)
Adverse Effects
Adverse effects related to radiofrequency
Measured: "1 month"
Quality
Breast-Q
Measured: "1 month"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start1 May 2020
- Primary completion9 Sep 2025
- Study completion9 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Radiofrequency ablation
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amparo Garcia-Tejedor, Hospital Universitari de Bellvitge
- Investigators
- Amparo Garcia-Tejedor, MDPhD, Principal investigator, Hospital Universitari Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04389216
- Sponsor's protocol ID
- ICPS002/20
- Acronym
- RFA
- Status last verified
- Sep 2025
- First submitted
- 3 May 2020
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Ablation in Breast Tumors in Early Stages
- ClinicalTrials.gov ID
- NCT04389216
- Acronym / sponsor ID
- RFA / ICPS002/20
- Conditions
- Breast Cancer Female
- Keywords
- radiofrequency, early stage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 9 Sep 2025 (actual)
- Study completion
- 9 Sep 2025 (actual)
- First posted
- 15 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Radiofrequency ablation
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency Ablation Tumor | Experimental | Device: Cool-tip electrode for Radiofrequency AblationRadiofrequency Ablation of breast cancer tumour by Cool-tip electrode. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Personal antecedents of breast cancer
- Multifocality or intraductal carcinoma
- Lobular infiltrating carcinoma
- Neoadjuvant therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cool-tip electrode for Radiofrequency AblationRadiofrequency ablation of the tumour in the surgery group, associated whith axillary surgery when applicable | Device | Radiofrequency Ablation Tumor |
Primary outcome
MRI post-RFA
Time frame: "1 month"
Magnetic Resonance Image after Radiofrequency ablation to confirmate complete disappearance of tumor contrast enhancement (residual mm).
BAG post-RFA
Time frame: "1 month"
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%).
2 secondary outcomes
Adverse Effects
Time frame: "1 month"
Quality
Time frame: "1 month"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amparo Garcia-Tejedor, MDPhD principal investigator
Hospital Universitari Bellvitge
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cool-tip electrode for Radiofrequency Ablation in people with Breast Cancer Female, run by Hospital Universitari de Bellvitge at 2 sites in Spain.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI post-RFA (time frame: "1 month"). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2025.