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临床试验/NCT00991978
NCT00991978已完成早期 1 期

Vascular Endothelial Growth Factor (VEGF) Imaging for Early Breast Cancer Detection A Feasibility Study

University Medical Center Groningen2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2010年3月最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
入组人数
23
试验地点
2
主要终点
SUV in tumour and lymph nodes

研究概览

简要总结

Breast cancer is the most common cause of cancer death among women. Yearly around 12,500 Dutch women are diagnosed with breast cancer and 3,500 die of this disease. One of the problems leading to such striking effect refers to late tumor detection due to inadequate sensitivity of current imaging techniques. Current screening is performed by means of mammography, consisting of traditional film-screen mammograms of digital mammograms. These digital mammograms offer digital enhancement to aid interpretation, which is especially helpful in women with dense breast tissue. Screening mammography is nowadays the single most effective method of early breast cancer detection. For screening of high risk individuals, increasingly the magnetic resonance imaging (MRI) technique is emerging. However, none of the above mentioned techniques has an optimal sensitivity and specificity, leading for instance to a significant portion of false positive results. The clinical consequence of this error is that additional tests and procedures are performed in women who may not have cancer. In the United States, for example, 11% mammograms require additional evaluation; the lesion turns out to be benign in more than 90% of cases [1].

False-positive readings False positive readings are more common in younger women, both because the tests are less specific and because breast cancer is less common [2,3]. As a result, more follow-up procedures, including invasive procedures such as biopsies, will be done in younger women even though fewer cancers will be found. Furthermore, because breast cancer screening occurs repeatedly, the risk of a false-positive study is likely to rise with repeated screening [4].

Emerging adjuncts to mammography include ultrasonography, which is helpful for further assessment of known areas of interest, and magnetic resonance imaging. Image-guided biopsy - directed by ultrasonography or stereotactic mammography views - plays a critical role in histological confirmation of suspected breast cancer.

详细描述

Objectives of the trial

Primary objective The aim is to perform a feasibility study to show that VEGF PET imaging using 89Zr-bevacizumab as tracer can be used for early breast cancer detection.

Secondary Objectives A secondary aim is whether positive lymph nodes can be detected.

End-points

  • The primary endpoint will be 89Zr-bevacizumab tracer uptake in primary breast tumors < 2 cm.
  • The secondary endpoint will be 89Zr-bevacizumab tracer uptake in axillary lymph nodes.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with a breast tumor size < 2 cm in diameter (as determined by means of conventional imaging techniques: mammography, ultrasound or MRI) who are scheduled to receive operative intervention either by means of a mastectomy or lumpectomy.
  • histologically proven breast cancer
  • Age > 18 years.
  • WHO performance status 0-2 (see: appendix B)
  • Signed written informed consent (approved by the Institutional Review Board [IRB]/ Independent Ethics Committee [IEC]) obtained prior to any study specific screening procedures.
  • Able to comply with the protocol.

排除标准

  • Other invasive malignancy or condition which could affect compliance with the protocol or interpretation of results.
  • Pregnant or lactating women. Documentation of a negative pregnancy test must be available for pre-menopausal women with intact reproductive organs and for women less than two years after menopause.
  • Prior radiotherapy on the involved area.
  • Major surgery within 28 days before the initiation of the study.
  • Clinically significant cardiovascular disease.
  • Prior allergic reaction to immunoglobulins or immunoglobulin allergy.

结局指标

主要结局

SUV in tumour and lymph nodes

时间窗: 4 days

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

C.P. Schroder

dr.

University Medical Center Groningen

研究点 (2)

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