SPECT/CT Imaging of Epithelial Cell Adhesion Molecule (EpCam) Expression in Triple Negative and Luminal Breast Cancer Using Technicium-99m-labelled Designed Ankyrin Repeat Proteins Ec1-G3C ([99mTc]Tc-DARPinEc1-G3C)
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Gamma camera-based whole-body [99mTc]Tc-DARPinEc1-G3C uptake value (%)
研究概览
简要总结
The study should evaluate distribution of [99mTc]Tc-DARPinEc1-G3C in patients with primary Triple negative and Luminal breast cancer.
The primary objective are:
- To assess distribution of [99mTc]Tc-DARPinEc1-G3C in normal tissues and in tumors over time;
- To evaluate dosimetry of [99mTc]Tc-DARPinEc1-G3C in breast cancer patients;
- To obtain initial information concerning safety and tolerability of [99mTc]Tc-DARPinEc1-G3C in breast cancer patients after single intravenous injection:
The secondary objective are:
1. To compare the tumour imaging data with [99mTc]Tc-DARPinEc1-G3C in breast cancer patients with Triple negative and Luminal subtypes.
详细描述
Overall goal of the project: To determine EpCam expression in primary breast cancer before any system therapy.
Phase I. Distribution of [99mTc]Tc-DARPinEc1-G3C in patients with primary breast cancer. The study should evaluate distribution of [99mTc]Tc-DARPinEc1-G3C in patients with primary Triple negative and Luminal breast cancer before treatment.
Methodology: Open-label, exploratory, single center study. The subjects will receive a single injection of the labelled tracer.
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 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
- •Morphological verification of Breast Cancer T2-4N0-3M0-1
- •Negative HER2 expression in primary tumour tissue according ASCO/CAP 2023 recommendation
- •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
- •Refusal from the study
- •Any system/local treatment
- •Second, non-breast malignancy
- •Active current autoimmune/infection disease or history of autoimmune disease. 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
结局指标
主要结局
Gamma camera-based whole-body [99mTc]Tc-DARPinEc1-G3C uptake value (%)
时间窗: 6 hours
Whole-body \[99mTc\]Tc-DARPinEc1-G3C uptake coinciding with normal organs and tissues will be assessed using gamma camera and calculated as percentage (%) of the injected dose of the radiopharmaceutical.
SPECT-based [99mTc]Tc-DARPinEc1-G3C uptake value in tumor lesions (counts)
时间窗: 6 hours
\[99mTc\]Tc-DARPinEc1-G3C uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts.
SPECT-based [99mTc]Tc-DARPinEc1-G3C background uptake value (counts)
时间窗: 6 hours
Focal uptake of \[99mTc\]Tc-DARPinEc1-G3C in the regions without pathological findings will be assessed with SPECT and measured in counts
Tumor-to-background ratio (SPECT)
时间窗: 6 hours
The SPECT-based tumor-to-background ratio will be calculated as follows: the value of \[99mTc\]Tc-DARPinEc1-G3C uptake coinciding with tumor lesions (counts) will be divided by the value of \[99mTc\]Tc-DARPinEc1-G3C uptake coinciding with the regions without pathological findings (counts)
Gamma camera-based whole-body [99mTc]Tc-DARPinEc1-G3C uptake value (percent)
时间窗: 6 hours
Whole-body \[99mTc\]Tc-DARPinEc1-G3C uptake coinciding with normal organs and tissues will be assessed using gamma camera and calculated as percentage (%) of the injected dose of the radiopharmaceutical.
次要结局
- Safety attributable to [99mTc]Tc-DARPinEc1-G3C injections (physical examination)(48 hours)
- Safety attributable to [99mTc]Tc-DARPinEc1-G3C injections (vital signs)(48 hours)
- Safety attributable to [99mTc]Tc-DARPinEc1-G3C injections (incidence and severity of adverse events)(48 hours)
- Safety attributable to [99mTc]Tc-DARPinEc1-G3C injections (concomitant medication)(48 hours)
- Percent of cases with abnormal findings based on the assessments of physical examination relative to baseline(48 hours)
- Percent of cases with abnormal findings based on the assessments of vital signs relative to baseline(48 hours)
- Rate of adverse events (percent)(48 hours)
- Rate of administration of concomitant medication (percent)(48 hours)