WILL MULTIFUNCTIONAL MAGNETIC RESONANCE TECHNIQUES, DETAILED HISTOPATHOLOGICAL ANALYSIS AND PRONE TREATMENT POSITION IMPROVE ACCURACY OF TARGET VOLUME LOCALISATION & DEFINITION AND REDUCE EXPOSURE OF NORMAL TISSUES IN BREAST RADIOTHERAPY?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Difference in lung NTDmean (biologically weighted [normalized] mean of total dose to lung normalized to 2 Gy fractions) in supine vs prone positions
研究概览
简要总结
RATIONALE: Diagnostic procedures, such as multifunctional magnetic resonance imaging and CT scans, may help reduce normal tissue damage in patients undergoing radiation therapy for cancer.
PURPOSE: This clinical trial is studying how well radiation therapy planning techniques work in reducing damage to normal tissue in women undergoing breast-conserving surgery for ductal breast carcinoma.
详细描述
OBJECTIVES:
- To improve precision of tumor bed localization and definition of clinical target volume, and to reduce normal tissue irradiation in women undergoing partial breast or breast boost radiotherapy.
- To test whether post-operative MRI improves the precision of tumor bed delineation after wide-local excision in comparison with the current standard CT scan/clip method.
- To determine the impact of tumor position within the excision specimen upon the localization of clinical target volume in relation to the tumor bed.
- To compare theoretical non-target tissue exposure from partial breast irradiation planned in the supine and prone (face-down) positions.
OUTLINE: Patients undergo planned breast-conservation surgery and placement of titanium clips to the four radial, the deep, and superficial margins of the excision cavity (for localization of tumor bed).
Within 2 weeks after surgery, patients undergo supine radiotherapy-planning CT scan as standard analysis. Patients then undergo a radiotherapy-planning CT scan in the prone position. Patients complete a linear analogue questionnaire after both scans designed to assess patient comfort and anxiety in each position. Patients then undergo multifunctional MRI (including dynamic contrast-enhancement MRI and diffusion-weighted MRI) of the ipsilateral breast in the prone position (≥ 3 weeks after surgery). If suspicious lesions ≥ 5 mm are found on MRI, patients are referred for a second-look ultrasound with biopsy (if lesion visible on ultrasound); where suspicious lesions are seen only on MRI, patients undergo MRI-guided biopsy. Lesions < 5 mm are included in the whole-breast radiotherapy treatment.
研究设计
- 研究类型
- Interventional
- 主要目的
- Diagnostic
- 盲法
- None
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
- •DISEASE CHARACTERISTICS:
- •Planning to undergo breast-conserving surgery (BCS)* for unifocal ductal carcinoma in situ (DCIS) or grade 1-2 invasive ductal carcinoma (IDC) of the breast NOTE: *Patients who have underwent BCS and have titanium clips placed according to this protocol are eligible for this study.
- •No T4d or multifocal disease (as defined on mammography or ultrasound)
- •No G3 disease
- •Hormone receptor status not specified
- •PATIENT CHARACTERISTICS:
- •Inclusion criteria:
- •Menopausal status not specified
排除标准
- •Cup size DD or greater
- •Ferromagnetic implants (exclude participation in MRI)
- •Claustrophobia (exclude participation in MRI)
- •Gadolinium allergy
- •PRIOR CONCURRENT THERAPY:
- •No prior surgery to ipsilateral breast
- •No prior neoadjuvant chemotherapy
结局指标
主要结局
Difference in lung NTDmean (biologically weighted [normalized] mean of total dose to lung normalized to 2 Gy fractions) in supine vs prone positions
次要结局
- Closeness of agreement between MRI-based vs CT scan/clip- based delineation of tumor bed
- Closeness of agreement between clinical target volumes (CTVs) defined using uniform margin vs those defined using knowledge of all excision margins
- Difference in NTDmean to ipsilateral non-planning target volume (PTV) breast tissue, chest wall muscle, and heart
- Difference in mean volume of PTV in supine versus prone positions
- Difference in dose homogeneity within PTV in each position
- Difference in complexity of beams needed to achieve above dose homogeneity within PTV
- Patient comfort with each positioning technique (assessed by questionnaire)
