The Role of the Novel 99mTc-NC100692 Tracer in Patients at High Risk or Known Breast Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 75
- 试验地点
- 1
研究概览
简要总结
Technetium-99m NC100692 Injection is under development as a diagnostic radiopharmaceutical for targeting angiogenesis associated with diseases such as primary and metastatic cancer, and for targeting active fibrosis in cardiac diseases such as developing heart failure and developing hypertrophic cardiomyopathy.
A principle goal of imaging is identification of disease processes early in their development, at times prior to symptoms. In cancer, angiogenesis is essential for a tumour to exceed approximately 1-2 mm3 in size.As markers of angiogenesis are often expressed early in the growth of a tumour it is postulated that imaging of angiogenesis can assist in early diagnosis of cancer, relapse or spread, and monitoring response to therapy.
Technetium-99m NC100692 Injection will be tested on 3 populations of pts:
1.30 patients at high risk For breast cancer 2.30 patients with breast cancer 3.15 patients with locally advanced breast cancer undergoing treatment.
详细描述
Angiogenesis is the formation of new blood vessels from the existing vascular bed. Certain integrins are upregulated while angiogenesis and myocardial fibrogenesis. Therefore, targeting an integrin with an imaging agent can be potentially useful for the early diagnosis of angiogenesis and/or fibrogenesis of malignant processes and myocardial remodelling.
Trail design
Arm 1:
Study cohort will include 30 patients. After the IV injection of 630-700 MBq 99mTc-NC100692 each breast will be imaged in CC and oblique views using the MBI system. Scintigarphic findings will be correlated with tissue diagnosis and or/ imaging and clinical follow- up of at least 6 months as well as with MRI, if performed, in order to determine the PPV and the NPV of the technology of MBI with labeled NC100692 for detection of tumors and differentiating benign and malignant breast lesions.
Arm 2 :
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Age ≥ 18 years.
- •Patients with unknown breast cancer but unclear lesions in the breast on other modalities or patients at high risk for breast cancer (BRCA, familial)- Arm 1
- •patients with breast cancer referred for 18-FDG PET-CT for staging or re-staging- Arm 2
- •Study cohort will include 15 patients with locally advanced breast cancer. Patients will undergo imaging prior to treatment and at its end- Arm 3
- •Written signed informed consent to participate in the study.
- •Patients not pregnant or lactating.
排除标准
- •Patients with breast cancer who do not fall into one of the three study arms.
- •Pregnant or lactating females.
- •Participation in another investigational study.
研究者
Michal Roll PhD,MBA
director, R&D Division
Tel-Aviv Sourasky Medical Center