Primary Breast CancerPhase 1EpCam-ScanNCT07784660
Molecular Imaging of EpCam Expression in Breast Cancer Using [99mTc]Tc-DARPinEc1-G3C
A Phase 1 study testing [99mTc]Tc-DARPinEc1-G3C in people with Primary Breast Cancer, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Primary Breast Cancer
- What is being tested?
- [99mTc]Tc-DARPinEc1-G3C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteRussia
- Study dates
- 22 Jun 2026to 1 Aug 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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:
- To compare the tumour imaging data with [99mTc]Tc-DARPinEc1-G3C in breast cancer patients with Triple negative and Luminal subtypes.
Read the detailed description
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.
- Conditions
- Primary Breast Cancer
- Being tested
- [99mTc]Tc-DARPinEc1-G3C
- Keywords
- Breast Cancer, EpCAm expression, [99mTc]Tc-DARPinEc1-G3C
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[99mTc]Tc-DARPinEc1-G3CDrug
Also called SPECT
One single injection of [99mTc]Tc-DARPinEc1-G3C, followed by gamma camera imaging directly postinjection and after 2, 4, 6, 24 and 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| One single injection of [99mTc]Tc-DARPinEc1-G3C | Experimental | 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. Receives: Drug: [99mTc]Tc-DARPinEc1-G3C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gamma camera-based whole-body [99mTc]Tc-DARPinEc1-G3C uptake value (percent)
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.
Measured: 6 hours
SPECT-based [99mTc]Tc-DARPinEc1-G3C uptake value in tumor lesions (counts)
[99mTc]Tc-DARPinEc1-G3C uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts.
Measured: 6 hours
SPECT-based [99mTc]Tc-DARPinEc1-G3C background uptake value (counts)
Focal uptake of [99mTc]Tc-DARPinEc1-G3C in the regions without pathological findings will be assessed with SPECT and measured in counts
Measured: 6 hours
Tumor-to-background ratio (SPECT)
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)
Measured: 6 hours
Secondary outcomes (4)
Percent of cases with abnormal findings based on the assessments of physical examination relative to baseline
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)
Measured: 48 hours
Percent of cases with abnormal findings based on the assessments of vital signs relative to baseline
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)
Measured: 48 hours
Rate of adverse events (percent)
The safety attributable to [99mTc]Tc-DARPinEc1-G3C injections will be evaluated based on the rate of adverse events (percent)
Measured: 48 hours
Rate of administration of concomitant medication (percent)
The safety attributable to [99mTc]Tc-DARPinEc1-G3C injections will be evaluated based on the rate of administration of concomitant medication (percent)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start22 Jun 2026
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Diagnostic SPECT for EpCam expression in primary breast tumours
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vladimir I. Chernov, Principal investigator, Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784660
- Sponsor's protocol ID
- ORI-2026.09.06
- Acronym
- EpCam-Scan
- Status last verified
- Jun 2026
- First submitted
- 20 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07784660
- Acronym / sponsor ID
- EpCam-Scan / ORI-2026.09.06
- Conditions
- Primary Breast Cancer
- Keywords
- Breast Cancer, EpCAm expression, [99mTc]Tc-DARPinEc1-G3C
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of SciencesUniversity, hospital or other
- Study start
- 22 Jun 2026 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To compare the tumour imaging data with [99mTc]Tc-DARPinEc1-G3C in breast cancer patients with Triple negative and Luminal subtypes.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Diagnostic SPECT for EpCam expression in primary breast tumours
| Arm | Type | Receives |
|---|---|---|
| One single injection of [99mTc]Tc-DARPinEc1-G3C | Experimental | Drug: [99mTc]Tc-DARPinEc1-G3CA 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [99mTc]Tc-DARPinEc1-G3CAlso: SPECTOne single injection of [99mTc]Tc-DARPinEc1-G3C, followed by gamma camera imaging directly postinjection and after 2, 4, 6, 24 and 48 hours. | Drug | One single injection of [99mTc]Tc-DARPinEc1-G3C |
Primary outcome
Gamma camera-based whole-body [99mTc]Tc-DARPinEc1-G3C uptake value (percent)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
4 secondary outcomes
Percent of cases with abnormal findings based on the assessments of physical examination relative to baseline
Time frame: 48 hours
Percent of cases with abnormal findings based on the assessments of vital signs relative to baseline
Time frame: 48 hours
Rate of adverse events (percent)
Time frame: 48 hours
Rate of administration of concomitant medication (percent)
Time frame: 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vladimir I. Chernov principal investigator
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [99mTc]Tc-DARPinEc1-G3C in people with Primary Breast Cancer, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gamma camera-based whole-body [99mTc]Tc-DARPinEc1-G3C uptake value (percent) (time frame: 6 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.