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临床试验/NCT00602628
NCT00602628已完成不适用

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?

Royal Marsden NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2007年11月1日最近更新:
适应症

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

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)

研究者

申办方类型
Other

研究点 (2)

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