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)

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.

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