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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ 1
連絡先と場所
研究場所
-
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Tomsk Reg
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Tomsk、Tomsk Reg、ロシア、634050
- Russia Tomsk NRMC
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
SPECT-based [99mTc]Tc-DARPinEc1-G3C uptake value in tumor lesions (counts)
時間枠：6 hours
|
[99mTc]Tc-DARPinEc1-G3C uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts.
|
6 hours
|
|
SPECT-based [99mTc]Tc-DARPinEc1-G3C background uptake value (counts)
時間枠：6 hours
|
Focal uptake of [99mTc]Tc-DARPinEc1-G3C in the regions without pathological findings will be assessed with SPECT and measured in counts
|
6 hours
|
|
Tumor-to-background ratio (SPECT)
時間枠：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)
|
6 hours
|
|
Gamma camera-based whole-body [99mTc]Tc-DARPinEc1-G3C uptake value (percent)
時間枠：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.
|
6 hours
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percent of cases with abnormal findings based on the assessments of physical examination relative to baseline
時間枠：48 hours
|
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)
|
48 hours
|
|
Percent of cases with abnormal findings based on the assessments of vital signs relative to baseline
時間枠：48 hours
|
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)
|
48 hours
|
|
Rate of adverse events (percent)
時間枠：48 hours
|
The safety attributable to [99mTc]Tc-DARPinEc1-G3C injections will be evaluated based on the rate of adverse events (percent)
|
48 hours
|
|
Rate of administration of concomitant medication (percent)
時間枠：48 hours
|
The safety attributable to [99mTc]Tc-DARPinEc1-G3C injections will be evaluated based on the rate of administration of concomitant medication (percent)
|
48 hours
|
協力者と研究者
捜査官
- 主任研究者：Vladimir I. Chernov、Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- ORI-2026.09.06
個々の参加者データ (IPD) の計画
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