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

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ClinicalTrials.gov Identifier: NCT02975128
Recruitment Status : Recruiting
First Posted : November 29, 2016
Last Update Posted : April 12, 2018
Sponsor:
Collaborators:
Canisius-Wilhelmina Hospital
Dutch Cancer Society
Information provided by (Responsible Party):
Radboud University

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.

Condition or disease Intervention/treatment Phase
Breastcancer Device: BLES system and conventional lumpectomy Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Minimal Invasive Breast Cancer Excision Using the Breast Lesion Excision System Under Ultrasound Guidance
Actual Study Start Date : February 19, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Patients 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.




Primary Outcome Measures :
  1. 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'.


Secondary Outcome Measures :
  1. Quality of the margin evaluation of the biopsy specimen and the eventual surgical specimen. [ Time Frame: Through study completion, an average of two months ]
  2. 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 ]
  3. 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



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02975128


Contacts
Contact: Wendelien Sanderink, MSc wendelien.sanderink@radboudumc.nl
Contact: Ritse Mann, MD, PhD Ritse.Mann@radboudumc.nl

Locations
Netherlands
Radboudumc Recruiting
Nijmegen, Gelderland, Netherlands, 6500 HB
Contact: Ritse Mann, MD, PhD       Ritse.Mann@radboudumc.nl   
Contact: Wendelien Sanderink, MSc       wendelien.sanderink@radboudumc.nl   
Canisius Wilhelmina Hospital Recruiting
Nijmegen, Gelderland, Netherlands, 6532 SZ
Contact: Luc Strobbe, MD, PhD         
Contact: Wendelien Sanderink, MSc       wendelien.sanderink@radboudumc.nl   
Sponsors and Collaborators
Radboud University
Canisius-Wilhelmina Hospital
Dutch Cancer Society
Investigators
Principal Investigator: Ritse Mann, MD, PhD Radboud University

Publications:
Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT02975128     History of Changes
Other Study ID Numbers: NL58040.091.16
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Radboud University:
Minimal invasive
Biopsy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases