AzTrials
AzTrials

Breast CancerNCT02281812

Radiofrequency Ablation in Breast Cancer

A study testing Radiofrequency ablation in people with Breast Cancer, run by Hospital Universitari de Bellvitge at 1 site in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

Background/Main objective: Radiofrequency ablation (RFA) is a minimally invasive procedure widespread accepted in the treatment of different tumors, especially in the liver but its benefit is not yet well-known in breast cancer. Read more about this study

Who is it for?
Ages 40 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Radiofrequency ablation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSpain
Study dates
Sep 2013to Jul 2017
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 40 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Breast single tumor,
  • Clearly visible by ultrasound,
  • Diameter < 2 cm
  • Located >1 cm from the chest wall and skin;
  • Ductal carcinoma according to previous biopsy,
  • < 20% of intraductal carcinoma

Who cannot join

  • Breast cancer in men;
  • Personal history of ipsilateral breast cancer;
  • Age <40 years;
  • Pregnancy or breastfeeding;
  • Suspicion of intraductal extension or multifocality by mammography or MRI;
  • Tumour not visible by ultrasound;
Show all 11Show fewer
  • Diameter > 2 cm;
  • Distance to muscle or skin <1 cm;
  • Lobular carcinoma;
  • Intraductal carcinoma in > 20% of the biopsy sample
  • Patients undergoing neoadjuvant chemotherapy or hormonotherapy.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Universitario Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08908

Other trials in Spain

About this study

Official title: Impact of Radiofrequency Ablation on Surgical Margins in Early Stage of Malignant Breast Tumors

Background/Main objective: Radiofrequency ablation (RFA) is a minimally invasive procedure widespread accepted in the treatment of different tumors, especially in the liver but its benefit is not yet well-known in breast cancer.

Our main objective is to evaluate the usefulness of RFA in < 2cm malignant breast tumors to reduce the proportion of positive margins.

Read more

Methodology: The investigator propose a single-center, single-blind, phase I and II randomized controlled trial. Phase I:Security of the cool-tip cluster electrode assessing the potential adverse effects in three stages: initial,intermediate and final. Phase II: Randomized clinical trial, 2 parallel groups with 37 patients in each one.

Experimental group: percutaneous RFA previous to conventional lumpectomy. Control group: conventional surgery with lumpectomy. The number of positive margins in both groups, and the need of extending margin resection will be assessed intraoperatively. Inclusion criteria: women >40 years, infiltrating ductal breast carcinoma by biopsy. The tumor must be unique, visible by ultrasound, smaller than 2cm and located > 1 cm from the chest wall and the skin. Patients will be followed up for a period of two years to assess cosmetic result, short -term and long -term complications and recurrences.

Expected results: The "cool-tip" (cluster) ablation method reduces by at least 30% the risk of intraoperative extensions for positive margins during lumpectomy compared to conventional surgery in breast tumors with a diameter < 2 cm.

Therefore this procedure may reduce the risk of second surgeries and the removed volume of tissue.Consequently the final cosmetic result should be improved.

Read the detailed description

Main objectives of the project:

  • To evaluate the usefulness of radiofrequency ablation (RFA) to achieve a lower percentage of positive margins.
  • To validate clinically the efficacy and safety of the method in breast tumors smaller than < 2 cm.

Specific objectives of the project:

  1. To demonstrate that , after RFA, clear margins are increased in the intraoperative pathological analysis compared to conventional surgery.
  2. To quantify the number of positive margins requiring intraoperative extension in each patient, comparing the ratio in both groups.
  3. To quantify the percentage of patients requiring intraoperative extension compared in both groups.
  4. To demonstrate a reduction in the volume of breast tissue removed after RFA compared to conventional surgery.
  5. Comparing in both groups the anteroposterior, transverse and craniocaudal diameters of the excised specimen, measured in cm, and to calculate the volume.
  6. Tumor weight in grams (including extensions) will be measured to compare the weights in both groups.
  7. To evaluate the differences in cosmetic outcome after RFA versus conventional surgery.
  8. An international scale will be used and the scores will be compared. There will be two independent assessments, one for the physician and another for the patient.
  9. To demonstrate the effectiveness of the RFA by cluster "cool-tip" electrode in the experimental group.
  10. RFA is considered as complete when no viable tumor tissue is evidenced by oxidation-reduction reaction mediated by NADH-diaphorase after surgical resection. Mitochondrial dysfunction will be also evaluated by semiquantitative and quantitative method using the enzyme cytochrome c oxidase or Complex IV (COX) and tunel. Any residual viable tumor tissue will be considered as incomplete RFA.
  11. Risk factors for incomplete ablations will be analyzed, especially tumor vascularization.
  12. To demonstrate the safety of RFA by cluster "cool-tip" electrode in breast cancer tumors a. To quantify all side effects that may occur after the RFA and / or surgery and to correlate the complication rate in each group with severity.
Conditions
Breast Cancer
Being tested
Radiofrequency ablation
Keywords
Ablation Technique, Breast cancer, Stage 1, Lumpectomy
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Radiofrequency ablationProcedure or surgery

    After tumor ablation and excision of the tumor, the pathologist performed a macroscopic study of the specimen,measuring the distance between the tumor and the margin in order to indicate if extensions are mandatory. Secondly and delayed, margins will be evaluated microscopically by H\&E stain. Furthermore, the tumoral viability in the ablation zone will be evaluated by NADH-diaphorase, COX and tunnel.

Study groups in NCT02281812
Study groupRoleWhat they receive
RFA groupExperimentalA percutaneous (utlrasound-guided) radiofrequency ablation (RFA) of the tumor will be performed by the radiologist under general anesthesia. Immediately after, excision of the tumor with appropriate margin will be accomplished.
Receives: Procedure: Radiofrequency ablation
Control groupNo interventionNormal excision of the tumor according to the protocol

What is being measured

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

  1. Intraoperative free margins (distance between the tumor and the margin in order to indicate if extensions are mandatory.)

    The pathologist performed a macroscopic study of the specimen, measuring the distance between the tumor and the margin in order to indicate if extensions are mandatory.

    Measured: 1 hour

Secondary outcomes (2)

  1. Security of RFA (Adverse effects and cosmetic result)

    Adverse effects and cosmetic result will be evaluated 15 days after the procedure

    Measured: 15 days

  2. Efficacy of RFA (Tumoral viability in the ablation zone)

    Tumoral viability in the ablation zone will be evaluated by NADH-diaphorase, COX and tunel

    Measured: 7 days

Timeline

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

  1. First posted4 Nov 2014 (estimated)
  2. Study startSep 2013
  3. Primary completionJul 2017
  4. Study completionJul 2017

Why it stopped: Increased local adverse effect (breast inflamation and infection)

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02281812
Sponsor's protocol ID
AC133/12
Status last verified
May 2018
First submitted
30 Oct 2014
Last updated
4 Jun 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Garcia-Tejedor A, Guma A, Soler T, Valdivieso A, Petit A, Contreras N, Chappuis CG, Falo C, Pernas S, Amselem A, Pla MJ, Fernandez-Montoli E, Burdio F, Ponce J. Radiofrequency Ablation Followed by Surgical Excision versus Lumpectomy for Early Stage Breast Cancer: A Randomized Phase II Clinical Trial. Radiology. 2018 Nov;289(2):317-324. doi: 10.1148/radiol.2018180235. Epub 2018 Aug 21.

    PubMed 30129904

Questions about this trial

What is this clinical trial studying?

A study testing Radiofrequency ablation in people with Breast Cancer, run by Hospital Universitari de Bellvitge at 1 site 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 6 inclusion and 11 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: stopped early, as of the sponsor's last update on 4 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 was stopped early (reason given: Increased local adverse effect (breast inflamation and infection)). Results are not available in the source record.

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?

Intraoperative free margins (distance between the tumor and the margin in order to indicate if extensions are mandatory.) (time frame: 1 hour). 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 NCT02281812, which also lists 1 linked publication.

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 4 Jun 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in