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Minimal Invasive Breast Cancer Excision Using the Breast Lesion Excision System Under Ultrasound Guidance (BLES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02975128
Recruitment Status : Terminated (Needle production stopped)
First Posted : November 29, 2016
Last Update Posted : May 29, 2020
Sponsor:
Collaborators:
Canisius-Wilhelmina Hospital
Dutch Cancer Society
Information provided by (Responsible Party):
Radboud University

Tracking Information
First Submitted Date  ICMJE November 23, 2016
First Posted Date  ICMJE November 29, 2016
Last Update Posted Date May 29, 2020
Actual Study Start Date  ICMJE February 19, 2018
Actual Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2016)
Frequency of successful complete tumor excision by the BLES system. [ Time Frame: Through study completion, an average of two months ]
Successful is defined as 'having tumor free margins, and no residual (in situ) cancer in the surgical specimen'.
Original Primary Outcome Measures  ICMJE
 (submitted: November 23, 2016)
Frequency of successful complete tumor excision by the BLES system, where successful is defined as 'having tumor free margins, and no residual (in situ) cancer in the surgical specimen'. [ Time Frame: Through study completion, an average of two months ]
Successful is defined as 'having tumor free margins, and no residual (in situ) cancer in the surgical specimen'.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2016)
  • Quality of the margin evaluation of the biopsy specimen and the eventual surgical specimen. [ Time Frame: Through study completion, an average of two months ]
  • In biopsy specimen in which the margin is not completely tumor free, but the Dutch criterion for successful surgery is met (no more than focal (4 mm) margin involvement), we will specifically analyse the residual tumor burden in the surgical excision. [ Time Frame: Through study completion, an average of two months ]
  • Assess in retrospect whether we can predict successful tumor extraction based upon other factors than tumor size alone. [ Time Frame: 2 years ]
    Parameters categorized in:
    • Patient related variables obtained from a questionnaire
    • Lesion related variables
    • Imaging features
    • Surgical features
    • Histopathological and molecular features from the core biopsy
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Minimal Invasive Breast Cancer Excision Using the Breast Lesion Excision System Under Ultrasound Guidance
Official Title  ICMJE Minimal Invasive Breast Cancer Excision Using the Breast Lesion Excision System Under Ultrasound Guidance
Brief Summary This study will assess whether it is feasible to remove small breast cancers completely using the Breast Lesion Excision System under Ultrasound guidance.
Detailed Description

Rationale: In the Netherlands, ≥7000 women are operated for small breast cancers yearly. In this study, we will evaluate under which conditions it is possible to excise small breast cancers using the Breast Lesion Excision System (BLES) under ultrasound (US) guidance. When successful, this will allow ambulatory treatment of women with small breast cancers, improving the cosmetic outcome and quality of life.

Objective: Our study aim is to assess whether it is feasible to remove small breast cancers completely using the BLES system under US guidance.

Study design: This is a multi-centre, translational clinical phase II study in 125 women with cancers ≤1.5 cm based upon US measurements, and without mammographic evidence of more extensive disease (e.g. microcalcifications).

Study population: Women with cancers ≤1.5 cm based upon US measurements, if there is no mammographic evidence of more extensive disease (e.g. microcalcifications or extensive architectural distortion), and the tumor lies ≥6 mm away from the dermis, nipple or pectoral muscle, are eligible for this study.

Intervention: In 125 women with cancers ≤1.5 cm based upon US measurements, and without mammographic evidence of more extensive disease (e.g. microcalcifications), we will conduct additional preoperative breast MRI to ascertain lesion size, after informed consent has been obtained. If the lesion is confirmed ≤1.5 cm on MRI and lying ≥6 mm away from the dermis, nipple and pectoral muscle, the patient is eligible. Moreover, patients will be asked to fill out the questionnaire, detailing their risk profile and comorbidity index.

Under general anaesthesia for the normal surgical procedure, the tumor is first removed using the BLES system under US guidance, through a small skin incision (<1 cm). Next, the normal surgical procedure is performed, excising the BLES excision cavity and a ≥ 1cm margin of surrounding tissue, also guided by the US appearance after the BLES procedure. Margin assessment will be performed separately for the BLES excision and the surgical specimen of the surrounding tissue.

Main study parameters/endpoints: Main endpoint of the study is the frequency of successful complete tumor excision by the BLES system, where successful is defined as 'having tumor free margins, and no residual (in situ) cancer in the surgical specimen'.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Our approach allows to test the feasibility of this highly innovating approach to remove breast cancer, with minimal negative effects or possible complications.

While there is no direct benefit nor detrimental effect from this study to the patients participating, the study has large implications for many women, as breast cancer remains the most common cancer in women, and due to screening, most cancers are small. Further reduction of the impact of local treatment is still desired as the psychosocial and somatic effects of breast deformation can be substantial.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breastcancer
Intervention  ICMJE Device: BLES system and conventional lumpectomy
Each patient undergoes the same procedure. Under general anaesthesia for the normal surgical procedure, the tumor is first removed using the BLES system under US guidance. Next, the normal surgical procedure is performed, excising the BLES excision cavity and a ≥ 1cm margin of surrounding tissue, also guided by the US appearance after the BLES procedure.
Study Arms  ICMJE Experimental: Patients
Intervention: Device: BLES system and conventional lumpectomy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 27, 2020)
22
Original Estimated Enrollment  ICMJE
 (submitted: November 23, 2016)
125
Actual Study Completion Date  ICMJE July 31, 2019
Actual Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female
  • 19 years or older
  • US visible breast cancer with maximum diameter of 15 mm on US
  • Histologically proven invasive breast cancer
  • Willing and able to undergo preoperative breast MRI
  • Able to provide informed consent

Exclusion Criteria:

  • Poor US visibility of the breast cancer
  • Breast cancer closer than 6 mm to the dermis, nipple or pectoral muscle.
  • Contra-indications to breast MRI or intravenous contrast administration
  • Contra-indications for the use of diathermia
  • Unable to provide informed consent
  • Patients with breast implants
  • Patients with implanted electronics
  • Pregnancy
  • Neoadjuvant chemotherapy
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02975128
Other Study ID Numbers  ICMJE NL58040.091.16
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Radboud University
Study Sponsor  ICMJE Radboud University
Collaborators  ICMJE
  • Canisius-Wilhelmina Hospital
  • Dutch Cancer Society
Investigators  ICMJE
Principal Investigator: Ritse Mann, MD, PhD Radboud University
PRS Account Radboud University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP