跳至主要内容
临床试验/NCT00566085
NCT00566085已完成不适用

Molecular Breast Imaging: Evaluation of a New Technique Using Scintimammography as an Additional Diagnostic Tool for Women Undergoing Neoadjuvant Therapy for Breast Cancer - A Pilot Study

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2008年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
20
试验地点
2
主要终点
To document that pre- and post-neoadjuvant therapy tumor size can be satisfactorily assessed by molecular breast imaging and corresponds to tumor size evaluation by conventional breast imaging procedures (mammogram, ultrasound, MRI).

研究概览

简要总结

Molecular Breast Imaging is a highly promising novel methodology for breast cancer detection. Preliminary patient studies with our dual-detector system indicate that this system is capable of reliably detecting very small (5-10 mm) malignant lesions in the breast. Besides the usefulness of Molecular Breast Imaging for tumor detection, we speculate that tumor uptake and washout may be predictors to response to neoadjuvant therapy for patients with the diagnosis of breast cancer. We propose that in patients with breast cancer who undergo neoadjuvant chemotherapy or neoadjuvant hormone therapy that molecular breast imaging is an accurate test for assessing response rate to neoadjuvant therapy.

详细描述

Adjuvant therapy after surgery for breast cancer has provided significant benefits to patients at risk for relapse. However, the success of therapy for each individual patient will often take years to reveal. Preoperative (neoadjuvant) medical therapy is very potent as an initial treatment for inoperable and large operable breast cancers. Tumor regression can be achieved in the great majority of patients and downstaging frequently reduces the need for mastectomy and it has become clear that pathologic complete response is a good prognostic marker. Data from current trials suggest that survival is at least as good with preoperative as with postoperative neoadjuvant therapies (1). With this observation preoperative medical therapy has the advantage over post-operative neoadjuvant therapy that it can be used as a short term surrogate marker for long-term outcome. With this translational approach, the therapy for each patient can be more targeted and individualized leading to higher success rates; and further, new therapies for early breast cancer can be assessed much more quickly than is currently possible through protracted trials of neoadjuvant therapy (2). This approach is therefore being increasingly utilized in patients with lower stage breast cancers.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women age 18 - 90
  • Women with breast cancer scheduled to undergo neoadjuvant chemotherapy therapy or neoadjuvant hormone therapy
  • Women who have undergone any breast imaging procedure, and in whom a repeat imaging procedure is planned prior to definite surgery

排除标准

  • Pregnant or lactating
  • Unable to understand or sign a consent form
  • Physically unable to sit upright and still for 40 minutes

结局指标

主要结局

To document that pre- and post-neoadjuvant therapy tumor size can be satisfactorily assessed by molecular breast imaging and corresponds to tumor size evaluation by conventional breast imaging procedures (mammogram, ultrasound, MRI).

时间窗: Up to 6 months

次要结局

  • To document that post-neoadjuvant tumor size as determined by molecular breast imaging corresponds to tumor size found at time of surgery.(Up to 6 months)
  • To characterize patterns of tumor uptake and washout and determine if they are predictors of response to neoadjuvant chemotherapy or neoadjuvant hormone therapy.(Up to 6 months)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dietlind Wahner-Roedler

Principal Investigator

Mayo Clinic

研究点 (2)

Loading locations...

相似试验

New Technique as an Additional Diagnostic Tool for... | 临床试验