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

Breastcancer Clinical Trial

— BLES  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02975128
• Other study ID #: NL58040.091.16
• Status: Terminated
• Phase: N/A
• Start date: February 19, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: May 2019
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will assess whether it is feasible to remove small breast cancers completely using the Breast Lesion Excision System under Ultrasound guidance.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Breastcancer

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Canisius Wilhelmina Hospital	Nijmegen	Gelderland
Netherlands	Radboudumc	Nijmegen	Gelderland

Sponsors (3)

Lead Sponsor	Collaborator
Radboud University	Canisius-Wilhelmina Hospital, Dutch Cancer Society

Country where clinical trial is conducted

Netherlands, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quality of the margin evaluation of the biopsy specimen and the eventual surgical specimen.		Through study completion, an average of two months
Secondary	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
Secondary	Assess in retrospect whether we can predict successful tumor extraction based upon other factors than tumor size alone.	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	2 years