Our study aim is to assess whether it is feasible to remove small breast cancers completely using the BLES system under US guidance.
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint of this study is the frequency of successful complete tumour
excision by the BLES system, where successful is defined as *having tumour free
margins, and no residual (in situ) cancer in the surgical specimen'.
Secondary outcome
- An analysis will be performed to identify predicting factors for
underestimation and for complete excision of the lesion after BLES excision.
Factors included in the analysis are patient related variables, lesion related
variables, imaging features, surgical features and histopathological features
from the core biopsy.
- When tumour margins of the biopsy specimen are positive and a residual (in
situ) tumour in the surgical specimen is found, the agreement between
histopathologic examination of biopsy specimen and surgical specimen can be
assessed.
Background summary
Breast cancer is the most frequently diagnosed cancer in women worldwide. Each
year more than 130000 women with breast cancer are treated in the Netherlands.
The national screening program has reduced the average size of breast cancers.
Small breast cancers are nowadays generally treated with lumpectomy. While this
approach works well it results in disfiguring scars to the breast, and nearly
always more tissue is removed than strictly necessary. Recently the breast
lesion excision system (BLES) has been developed. This device, designed for
diagnostic breast biopsy, removes a lump of tissue through a very small skin
incision under mammographic or US guidance.
Study 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
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 tumour 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.
Study burden and risks
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.
Geert Grooteplein 10
Nijmegen 6525 GA
NL
Geert Grooteplein 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
Subjects must meet all of the following criteria to be included in the study:
1. Female sex;
2. 19 years or older;
3. US visible breast cancer;
4. Histologically proven invasive breast cancer with maximum diameter of 15 mm as assessed by US;
5. Willing and able to undergo preoperative breast MRI;
6. Able to undergo diathermic breast lesion excision;
7. Able to provide informed consent.
Exclusion criteria
Subjects who meet any of the following criteria will be excluded from the study:
1. Male sex;
2. 18 years or younger;
3. No proven invasive breast cancer;
4. Poor US visibility of the breast cancer;
5. Breast cancer closer than 6 mm to the skin, nipple or pectoral muscle;
6. Contra-indications to breast MRI or intravenous contrast administration;
7. Contra-indications for the use of diathermia;
8. Unable to provide informed consent;
9. Patients with breast implants;
10. Patients with implanted electronics;
11. Pregnancy.
12. Neoadjuvant therapy;
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL58040.091.16 |