Clinical trial · Interventional
Molecular Imaging of EpCam Expression in Breast Cancer Using [99mTc]Tc-DARPinEc1-G3C
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study should evaluate distribution of \[99mTc\]Tc-DARPinEc1-G3C in patients with primary Triple negative and Luminal breast cancer. The primary objective are: 1. To assess distribution of \[99mTc\]Tc-DARPinEc1-G3C in normal tissues and in tumors over time; 2. To evaluate dosimetry of \[99mTc\]Tc-DARPinEc1-G3C in breast cancer patients; 3. 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Breast Cancer | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [99mTc]Tc-DARPinEc1-G3C | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- One single injection of [99mTc]Tc-DARPinEc1-G3C
- description
- 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 Subjects withdrawn from the study for any reason will be replaced.
- interventionNames
- Drug: [99mTc]Tc-DARPinEc1-G3C
Primary outcomes (4)
- measure
- Gamma camera-based whole-body [99mTc]Tc-DARPinEc1-G3C uptake value (percent)
- timeFrame
- 6 hours
- description
- 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.
- measure
- SPECT-based [99mTc]Tc-DARPinEc1-G3C uptake value in tumor lesions (counts)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subject is \> 18 years of age 2. Morphological verification of Breast Cancer T2-4N0-3M0-1 3. Negative HER2 expression in primary tumour tissue according ASCO/CAP 2023 recommendation 4. ECOG 0-2. 5. 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 6. Subject is capable to undergo the diagnostic investigations to be performed in the study 7. Informed consent Exclusion Criteria: 1. Refusal from the study 2. Any system/local treatment 3. Second, non-breast malignancy 4. Active current autoimmune/infection disease or history of autoimmune disease. Known HIV positive or chronically active hepatitis B or C 5. Administration of other investigational medicinal product within 30 days of screening 6. Pregnancy 7. Ongoing toxicity \> grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's
References
Publications (0)
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