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Summary: Preliminary results of ultrasound studies do exist in the literature on the successful use of the MammoSite Radiation Therapy System (RTS), a new device for delivering brachytherapy following breast-conserving surgery. In Europe, some groups started a prospective multicentre trial to investigate the use of the MammoSite RTS. In this early publication, we analysed the surgical procedure and placement of the MammoSite, treatment planning and radiation delivery complications, and early cosmesis, as well as the comfort of the patients. Between June 2002 and March 2005, a total of 54 low-risk breast cancer patients fulfilling the enrolment criteria were implanted intra- or postoperatively using the MammoSite applicator. After inflating the balloon in the excision cavity, the reference isodose was defined 1cm from the balloon''s surface. Twenty-eight patients were treated with primary brachytherapy with a total dose of 34Gy (2×3.4Gy) and 16 patients had a boost with a mean dose of 13.3Gy (range: 7.5–15Gy; 2×2.5Gy) combined with external beam radiotherapy (EBRT). Doses ranged between 46 and 50Gy. We analysed the postimplant anatomic position of the applicator in relation to the skin and chest wall as well as the geometric form of the balloon via ultrasound, computed tomography and X-ray before, during and after the treatment. Forty-four out of 54 patients (81.5%) were eligible for MammoSite RTS brachytherapy. Ten patients were excluded from the trial due to the strict study criteria and received no brachytherapy. Balloon rupture occurred in two cases. We observed seroma in 16 patients (36%); furthermore, an abscess developed in two patients (4.5%) within 3 months of implantation. Postoperative air gaps and haematoma were successfully reduced by draining the operation cavity in one institution. At a mean follow-up of 14 months (range 3–31 months), the skin-related side effects observed were skin discoloration or inflammation in 36 patients (82%) and teleangiectasia in eight patients (18%). The MammoSite RTS is a feasible treatment modality for postoperative partial breast irradiation after breast-conserving surgery for selected low-risk breast cancer patients. The main advantage of the system is the necessity of only one applicator for the delivery of fractionated radiotherapy over a 5-day treatment period. In addition, patient tolerance of the procedure is high. Based on this early experience, the method may serve as a successful alternative to conventional multicatheter brachytherapy for a highly select group of patients, but we have to bear in mind the higher level of acute toxicity. [Copyright &y& Elsevier]