Prospective, Multicenter Registry Study Evaluating the Feasibility of Ultrasound-guided Clipping of Suspicious Intramammary Lesions in Primary Breast Cancer Patients Receiving Neoadjuvant Therapy (Ultra3Detect)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 339
- 试验地点
- 1
- 主要终点
- Sonographic detection rate of clip at the time of surgery after completion of NST
研究概览
简要总结
Neoadjuvant systemic therapy (NST) is increasingly recommended for patients with early breast cancer, and the rate of patients with pathological complete remission (pCR) is increasing due to the use of modern chemotherapy regimens and targeted therapies, especially in patients with human epidermal growth factor receptor 2 positive (HER2+) breast cancer and triple negative breast cancer (TNBC). It is therefore important to mark a lesion (with e.g. clip) before the start of NST in order to safely identify and localize a clip and (former) tumor bed after completion of NST. Reliable sonographic detection of the clip would be preferred to mammography-guided detection and marking. In addition to avoiding radiation exposure by mammography and reducing time, personnel and financial expenditure, ultrasound-guided wire marking of the clip is less painful for the patient than stereotactic wire marking.
The present prospective registry study aims to evaluate how often the intramammary Tumark® Vision clip can be detected by ultrasound after completion of NST in patients with TNBC and HER2+ breast cancer and thus, in the case of pCR, how often the elaborate clipping with mammographic (stereotactic) guidance can be avoided.
详细描述
Breast cancer patients whose carcinomas have an aggressive tumor biology which implies the need for chemotherapy are increasingly being treated with NST. As a standard procedure, clip placement of the suspicious lesion is performed after ultrasound-guided core biopsy or mammography-guided vacuum biopsy. Clipping is necessary to enable the clear identification of the sonographically suspicious area of the breast and safe surgical removal of the remaining tumor tissue (if any) during a later surgery, even following a good response under NST. The placement of a marker (clip) is particularly important for the precise localization of the original tumor bed in patients with pCR.
There are a number of commercially available markers (clips) which are indicated for intramammary marking of a lesion and which differ in terms of shape and material. Difficulties may arise in placing the clip in the tumor or the tumor center. In addition, the clip can dislocate from the initial location and/or the clip might not be visualized during response monitoring. Evaluations of the ultrasound-visible clip made of nitinol investigated in this study showed very good results regarding marker dislocation and visibility within 7 days after inital placement.The clip, which immediately unfolds into a 3-dimensional spherical structure after insertion into the tissue, could be detected by both sonography and mammography in all 50 cases after the intervention; however, long-term data data at follow-up controls during and after NST are not available so far.
According to current German guidelines, imaging-assisted wire marking is recommended without restriction before breast conserving surgery for non-palpable lesions. The clip is considered the target lesion for wire marking, which can be done under sonographic or stereotactic control. If the clip is reliably visible on ultrasound (even in patients with pCR), the stereotactic control of wire marking can be omitted. Therefore, the ability to visualize a clip in breast ultrasonography is of great importance.
The present multicenter study aims to evaluate the sonographic detection rate of the intramammary Tumark® Vision clips after NST in clinical routine and the proportion of cases in which the clip cannot be detected, and thus the rate of mammography-guided wire markings.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female patient aged ≥ 18 years
- •written informed consent
- •patient's consent to NST
- •suspicious unilateral or bilateral intramammary foci that can be safely identified by ultrasound
- •no evidence of distant metastasis (complete staging does not have to be present at inclusion)
- •indication for breast conserving therapy
- •no prior clip placement in the confirmed intramammary carcinoma
- •patient is able to undergo NST treatment (even if the indication based on tumor biology is not yet available)
- •high compliance and high number of planned relevant surgical interventions in participating study center
- •patient can understand the scope of this prospective registry study
排除标准
- •allergy to titanium and/or nickel
- •pregnancy
- •ipsilateral relapse (when NST: no exclusion criterion)
- •prior extensive breast surgery (starting from quadrant resection)
- •inflammatory breast cancer
- •extramammary breast cancer
- •multicentric or multifocal breast cancer
- •patient is not operable
- •patient is already undergoing adjuvant/neoadjuvant therapy
- •inability to understand the purpose of the clinical trial or to comply with study procedures
结局指标
主要结局
Sonographic detection rate of clip at the time of surgery after completion of NST
时间窗: At the time of surgery
Intraoperative detection rate of the clip in patients with HER2+ breast cancer or TNBC after at least 12 weeks of NST treatment
次要结局
- Number of ultrasound-guided clip placements per patient(Immediately after placement of clip)
- Sonographic detection rate of clips in all patients receiving NST and with pCR(Immediately after clip placement as well as after 4-8, 9-12,13-26 weeks of NST treatment and preoperatively)
- Intraoperative detection rate of the clip on specimen utrasound images(At the time of surgery)
- Proportion of patients with mammographic verification after sonographic wire-marking(Preoperatively)
- Visibility of the device (Tumark® Vision) cannula(During placement of clip)
- Complications associated with the application of the clip(Up to 6 months after placement of clip)
- Sonographic detection rate of clips in TNBC and HER2+ patients receiving NST(Immediately after clip placement as well as after 4-8, 9-12, 13-26 weeks of NST treatment and preoperatively)
- Number of patients with complete pathological remission(Up to 10 weeks after surgery)
- Rate of successful clip placements in the tumor center(Immediately after placement of clip)
- Intraoperative detection rate of the clip in specimen radiographs(At the time of surgery)
- Proportion of patients requiring preoperative, mammography-guided wire marking(Preoperatively)
- Sonographic detection rate of clips in patients receiving NST(Immediately after placement of clip as well as after 4-8, 9-12, 13-26 weeks of NST treatment and preoperatively)
- Sonographic detection rate of clips in patients not receiving NST(Immediately after clip placement and preoperatively)
- Proportion of patients with artifacts caused by clips(Up to 6 months after placement of clip)