Localization of Nonpalpable Breast Lesions
Localization of Nonpalpable Breast Lesions
Each year the Danish mammography-screening programme identifies a large number of patients
 with small non-palpable breast cancers or precancerous lesions. The majority of these
 patients are suitable for breast conserving surgery (BCS). The object of BCS is to remove the
 suspicious lesion completely without removing excess healthy breast tissue. To obtain this
 accurate lesion localization is essential.

 Until today the standard procedure in Denmark has been wire guided localization (WGL).
 Although the method has been utilized for a number of years it has several disadvantages.
 Often inaccurate lesion localization leads to incomplete lesion removal (positive margin) and
 subsequently reoperation. It can postpone the additional systemic treatment, offered after
 the operation. Other disadvantages are poor cosmetic outcome and inconvenient planning for
 the patient and the departments involved. The wire needs to be placed on the day of the
 operation, which decreases the flexibility of the procedure.

 The purpose of this study is to test a new method named radioactive seed localization (RSL).
 The method uses a small titanium seed containing radioactive iodine. It will be placed in the
 centre of the lesion, and during the operation, the surgeon can locate it with a handheld
 gamma probe. The seed can be placed a few days in advance, which means a more flexible course
 of treatment. The method seems promising with regards to reoperation rates, but it needs
 further testing.

 Hypothesis:

 RSL is a more accurate method, for localization of nonpalpable breast lesions, than WGL.
 Using RSL obtains, to a great extent, adequate negative margins, resulting in a reduced
 number of re-operations.

 The study will be performed as a randomised clinical trial, where the two methods will be
 compared to each other. The trial will be performed at the department of breast surgery at
 Rigshospitalet and include patients with nonpalpable breast lesions. Besides reoperation
 rates, duration of the surgical procedure and the amount of removed breast tissue will be
 compared.
Inclusion Criteria:

 -  Patients with nonpalpable breast lesions, carcinoma in situ or invasive carcinoma,
 where preoperative lesion localization is necessary.

 -  All age groups, minimum 18 years

 Exclusion criteria:

 -  Patients with benign nonpalpable breast lesions.

 -  Patients who are unable to comprehend the information.

 -  Patients who are pregnant, breastfeeding or have children < 3 years.

 -  Patients who have lesions, which requires more than two wires or seeds for
 localization.