NCT02975128

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
1.2 years until next milestone

Study Start

First participant enrolled

February 19, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

May 29, 2020

Status Verified

May 1, 2019

Enrollment Period

1.4 years

First QC Date

November 23, 2016

Last Update Submit

May 27, 2020

Conditions

Breastcancer

Keywords

Minimal invasiveBiopsy

Outcome Measures

Primary Outcomes (1)

  • Frequency of successful complete tumor excision by the BLES system.

    Successful is defined as 'having tumor free margins, and no residual (in situ) cancer in the surgical specimen'.

    Through study completion, an average of two months

Secondary Outcomes (3)

  • Quality of the margin evaluation of the biopsy specimen and the eventual surgical specimen.

    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.

    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.

    2 years

Study Arms (1)

Patients

EXPERIMENTAL
Device: BLES system and conventional lumpectomy

Interventions

BLES system and conventional lumpectomyDEVICE

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.

Patients

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Radboudumc

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

Canisius Wilhelmina Hospital

Nijmegen, Gelderland, 6532 SZ, Netherlands

Location

Related Publications (4)

  • Allen SD, Nerurkar A, Della Rovere GU. The breast lesion excision system (BLES): a novel technique in the diagnostic and therapeutic management of small indeterminate breast lesions? Eur Radiol. 2011 May;21(5):919-24. doi: 10.1007/s00330-010-2000-7. Epub 2011 Jan 15.

    PMID: 21240608BACKGROUND

  • Sie A, Bryan DC, Gaines V, Killebrew LK, Kim CH, Morrison CC, Poller WR, Romilly AP, Schilling K, Sung JH. Multicenter evaluation of the breast lesion excision system, a percutaneous, vacuum-assisted, intact-specimen breast biopsy device. Cancer. 2006 Sep 1;107(5):945-9. doi: 10.1002/cncr.22090.

    PMID: 16874817BACKGROUND

  • Medjhoul A, Canale S, Mathieu MC, Uzan C, Garbay JR, Dromain C, Balleyguier C. Breast lesion excision sample (BLES biopsy) combining stereotactic biopsy and radiofrequency: is it a safe and accurate procedure in case of BIRADS 4 and 5 breast lesions? Breast J. 2013 Nov-Dec;19(6):590-4. doi: 10.1111/tbj.12184. Epub 2013 Sep 19.

    PMID: 24102869BACKGROUND

  • Allen SD, Osin P, Nerurkar A. The radiological excision of high risk and malignant lesions using the INTACT breast lesion excision system. A case series with an imaging follow up of at least 5 years. Eur J Surg Oncol. 2014 Jul;40(7):824-9. doi: 10.1016/j.ejso.2014.03.022. Epub 2014 Apr 2.

    PMID: 24742589BACKGROUND

Study Officials

  • Ritse Mann, MD, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2016

First Posted

November 29, 2016

Study Start

February 19, 2018

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

May 29, 2020

Record last verified: 2019-05

Locations

NL(2)