Molecular Imaging of EpCam Expression in Breast Cancer Using [99mTc]Tc-DARPinEc1-G3C (EpCam-Scan)
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)
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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 阶段1
联系人和位置
学习地点
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Tomsk Reg
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Tomsk、Tomsk Reg、俄罗斯、634050
- Russia Tomsk NRMC
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- 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
- ECOG 0-2.
- 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
Exclusion Criteria:
- 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
- Pregnancy
- Ongoing toxicity > grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：One single injection of [99mTc]Tc-DARPinEc1-G3C
A single injected dose of 3000 µg of [99mTc]Tc-DARPinEc1-G3C will be evaluated. The study requires enrollment of at least five (5) evaluable subjects per pathology cohort (Triple negative breast cancer and Luminal breast cancer). Subjects withdrawn from the study for any reason will be replaced. |
One single injection of [99mTc]Tc-DARPinEc1-G3C, followed by gamma camera imaging directly postinjection and after 2, 4, 6, 24 and 48 hours.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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SPECT-based [99mTc]Tc-DARPinEc1-G3C uptake value in tumor lesions (counts)
大体时间：6 hours
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[99mTc]Tc-DARPinEc1-G3C uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts.
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6 hours
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SPECT-based [99mTc]Tc-DARPinEc1-G3C background uptake value (counts)
大体时间：6 hours
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Focal uptake of [99mTc]Tc-DARPinEc1-G3C in the regions without pathological findings will be assessed with SPECT and measured in counts
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6 hours
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Tumor-to-background ratio (SPECT)
大体时间：6 hours
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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)
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6 hours
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Gamma camera-based whole-body [99mTc]Tc-DARPinEc1-G3C uptake value (percent)
大体时间：6 hours
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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.
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6 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percent of cases with abnormal findings based on the assessments of physical examination relative to baseline
大体时间：48 hours
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The safety attributable to [99mTc]Tc-DARPinEc1-G3C injections will be evaluated based on the assessments of physical examination (percent of cases with abnormal findings relative to baseline)
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48 hours
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Percent of cases with abnormal findings based on the assessments of vital signs relative to baseline
大体时间：48 hours
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The safety attributable to [99mTc]Tc-DARPinEc1-G3C injections will be evaluated based on the assessments of vital signs (percent of cases with abnormal findings relative to baseline)
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48 hours
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Rate of adverse events (percent)
大体时间：48 hours
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The safety attributable to [99mTc]Tc-DARPinEc1-G3C injections will be evaluated based on the rate of adverse events (percent)
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48 hours
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Rate of administration of concomitant medication (percent)
大体时间：48 hours
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The safety attributable to [99mTc]Tc-DARPinEc1-G3C injections will be evaluated based on the rate of administration of concomitant medication (percent)
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48 hours
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合作者和调查者
调查人员
- 首席研究员：Vladimir I. Chernov、Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- ORI-2026.09.06
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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