BreastcancerBLESNCT02975128
Minimal Invasive Breast Cancer Excision Using the Breast Lesion Excision System Under Ultrasound Guidance
A study testing BLES system and conventional lumpectomy in people with Breastcancer, run by Radboud University Medical Center at 2 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Breastcancer
- What is being tested?
- BLES system and conventional lumpectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesNetherlands
- Study dates
- 19 Feb 2018to 31 Jul 2019
- 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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Patients with implanted electronics
- Pregnancy
- Neoadjuvant chemotherapy
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Radboudumc
Nijmegen, Gelderland, 6500 HB
Canisius Wilhelmina Hospital
Nijmegen, Gelderland, 6532 SZ
About this study
This study will assess whether it is feasible to remove small breast cancers completely using the Breast Lesion Excision System under Ultrasound guidance.
Read the 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.
- Conditions
- Breastcancer
- Being tested
- BLES system and conventional lumpectomy
- Keywords
- Minimal invasive, Biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Not described Receives: Device: BLES system and conventional lumpectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: 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.
Measured: 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.
Measured: 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.
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study start19 Feb 2018
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Why it stopped: Needle production stopped
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for BreastcancerStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Canisius-Wilhelmina Hospital, Dutch Cancer Society
- Responsible party
- Sponsor
- Investigators
- Ritse Mann, MD, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02975128
- Sponsor's protocol ID
- NL58040.091.16
- Acronym
- BLES
- Status last verified
- May 2019
- First submitted
- 23 Nov 2016
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 21240608Sie 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.
PubMed 16874817Medjhoul 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.
PubMed 24102869Allen 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.
PubMed 24742589
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Invasive Breast Cancer Excision Using the Breast Lesion Excision System Under Ultrasound Guidance
- ClinicalTrials.gov ID
- NCT02975128
- Acronym / sponsor ID
- BLES / NL58040.091.16
- Conditions
- Breastcancer
- Keywords
- Minimal invasive, Biopsy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Needle production stopped
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Canisius-Wilhelmina Hospital, Dutch Cancer Society
- Study start
- 19 Feb 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 29 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Device: BLES system and conventional lumpectomy |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BLES system and conventional lumpectomyEach 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. | Device | Patients |
Primary outcome
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'.
3 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Needle production stopped). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
- Background: PubMed 21240608Allen 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.
- Background: PubMed 16874817Sie 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.
- Background: PubMed 24102869Medjhoul 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.
- Background: PubMed 24742589Allen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ritse Mann, MD, PhD principal investigator
Radboud University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BLES system and conventional lumpectomy in people with Breastcancer, run by Radboud University Medical Center at 2 sites in Netherlands.
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 9 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 29 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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: Needle production stopped). 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?
Frequency of successful complete tumor excision by the BLES system. (time frame: Through study completion, an average of two months). 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 NCT02975128, which also lists 4 linked publications.
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 29 May 2020.