SPECT/CT Imaging of Gastrin-releasing Peptide Receptor Expression in Breast Cancer With Different Estrogen Receptor Expression Using Technetium-99m-labelled DB8 [99mTc]Tc-DB8
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- [99mTc]Tc-DB8 background uptake value
研究概览
简要总结
The study should evaluate the [99mTc]Tc-DB8 accumulation in primary tumour of breast cancer patients with positive and negative estrogen receptor expression.
详细描述
The aim of the study is to determine gastrin-releasing peptide receptor expression in primary breast cancer patients with positive and negative estrogen receptor expression before any systemic or local treatment.
Phase II. Assessment of [99mTc]Tc-DB8 accumulation in primary tumors with positive and negative estrogen receptor expression in breast cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject is > 18 years of age
- •Availability of results from estrogen receptor status by Immunohistochemistry previously determined on material from the primary tumor
- •Hematological, liver and renal function test results within the following limits:
- •White blood cell count: > 2.0 x 109/L
- •Hemoglobin: > 80 g/L
- •Platelets: > 50.0 x 109/L
- •ALT, ALP, AST: =< 5.0 times Upper Limit of Normal
- •Bilirubin =< 2.0 times Upper Limit of Normal
- •Serum creatinine: Within Normal Limits
- •A negative pregnancy test for all patients of childbearing potential. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception for at least 30 days after study termination
- •Subject is capable to undergo the diagnostic investigations to be performed in the study
- •Informed consent
排除标准
- •Any system therapy (chemo-/targeted therapy)
- •Second, non-breast malignancy
- •Active current autoimmune disease or history of autoimmune disease
- •Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening)
- •Known HIV positive or chronically active hepatitis B or C
- •Administration of other investigational medicinal product within 30 days of screening
- •Ongoing toxicity > grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's
研究组 & 干预措施
Breast cancer patients with positive estrogen receptor expression
Assessment of [99mTc]Tc-DB8 accumulation in primary tumour of breast cancer patients with positive estrogen receptor expression.
干预措施: [99mTc]Tc-DB8 (Drug)
Breast cancer patients with negative estrogen receptor expression
Assessment of [99mTc]Tc-DB8 accumulation in primary tumour of breast cancer patients with negative estrogen receptor expression.
干预措施: [99mTc]Tc-DB8 (Drug)
结局指标
主要结局
[99mTc]Tc-DB8 background uptake value
时间窗: 2 hours
SPECT/CT-based \[99mTc\]Tc-DB8 background uptake value (SUVmax)
Tumor-to-background ratio (SPECT/CT)
时间窗: 2 hours
The SPECT/CT-based tumor-to-background ratio will be calculated as follows: the value of \[99mTc\]Tc-DB8 uptake coinciding with tumor lesions (counts) will be divided by the value of \[99mTc\]Tc-DB8 uptake coinciding with the regions without pathological findings (SUVmax)
[99mTc]Tc-DB8 uptake in primary breast tumor
时间窗: 2 hours
SPECT/СT-based \[99mTc\]Tc-DB8 uptake in primary breast tumor with positive and negative estrogen receptor expression (SUVmax)
次要结局
- Estrogen receptor positive vs estrogen receptor negative [99mTc]Tc-DB8 uptake(2 hours)