Primary Breast CancerPhase 1NCT05923177
Molecular Imaging of HER2 Expression in Breast Cancer Using [123I] I-(HE)3-G3
A Phase 1 study testing SPECT 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 [123I] I-(HE)3-G3 in patients with primary HER2-positive and HER2-negative breast cancer 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?
- SPECT
- 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
- 1 Sep 2023to 1 Sep 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Availability of results from HER2 status previously determined on material from the primary tumor and metastatic LN, either a. HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive or b. HER2-negative, defined as a DAKO HercepTest™ score of 0 or 1+; or else if 2+ then FISH negative
- Hematological, liver and renal function test results within the following limits:
- White blood cell count: > 2.0 x 109/L
- Hemoglobin: > 80 g/L
- Platelets: > 50.0 x 109/L
Show all 12Show fewer
- ALT, ALP, AST: =< 5.0 times Upper Limit of Normal
- Bilirubin =< 2.0 times Upper Limit of Normal
- Serum creatinine: Within Normal Limits
- 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
- Any system therapy (chemo-/targeted therapy)
- Second, non-breast malignancy
- Active current autoimmune disease or history of autoimmune disease
- Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening) 4. Known HIV positive or chronically active hepatitis B or C
- Administration of other investigational medicinal product within 30 days of screening
- 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.
About this study
Official title: SPECT Imaging of Human Epidermal Growth Factor Receptor 2 (HER2) Expression in Breast Cancer Using Iodine -123-labelled Designed Ankyrin Repeat Proteins HE3-G3 ([123I] I-(HE)3-G3)
The study should evaluate distribution of [123I] I-(HE)3-G3 in patients with primary HER2-positive and HER2-negative breast cancer
Read the detailed description
Overall goal of the project: To determine HER2 expression level in primary breast cancer before neoadjuvant system therapy.
Phase I. Distribution of HE3-G3 ([123I] I-(HE)3-G3) in patients with primary breast cancer. The study should evaluate distribution of HE3-G3 ([123I] I-(HE)3-G3) in patients with primary HER2-positive and HER2-negative breast cancer.
- Conditions
- Primary Breast Cancer
- Being tested
- SPECT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPECTDrug
Also called [123I] I-(HE)3-G3
One single injection of [123I] I-(HE)3-G3, followed by gamma camera imaging directly postinjection and after 2, 4, 6, 24 and 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| The tested injected doses of [123I] I-(HE)3-G3 3000 μg | Experimental | At least five (5) evaluable subjects with HER2-positive status and at least five (5) subjects with HER2-negative status have to be enrolled in the study for each tested protein dose. The tested injected dose 3000 μg.
Subjects withdrawn from the study for any reason will be replaced Receives: Drug: SPECT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gamma camera-based whole-body [123I] I-(HE)3-G3 uptake value (%)
Whole-body [123I] I-(HE)3-G3 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-G3-(G3S)3C uptake value in tumor lesions (counts) [123I] I-(HE)3-G3 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts
SPECT-based [99mTc]Tc-G3-(G3S)3C uptake value in tumor lesions (counts) [123I] I-(HE)3-G3 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts
Measured: 6 hours
SPECT-based [123I] I-(HE)3-G3 background uptake value (counts)
Focal uptake of [123I] I-(HE)3-G3 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 [123I] I-(HE)3-G3 uptake coinciding with tumor lesions (counts) will be divided by the value of [123I] I-(HE)3-G3 uptake coinciding with the regions without pathological findings (counts)
Measured: 6 hours
Secondary outcomes (5)
Safety attributable to [123I] I-(HE)3-G3 injections (physical examination) (% of cases with abnormal findings relative to baseline)
The safety attributable to [123I] I-(HE)3-G3 injections will be evaluated based on the assessments of physical examination (% of cases with abnormal findings relative to baseline)
Measured: 48 hours
Safety attributable to [123I] I-(HE)3-G3 injections (vital signs) (% of cases with abnormal findings relative to baseline)
The safety attributable to [123I] I-(HE)3-G3 injections will be evaluated based on the assessments of vital signs (% of cases with abnormal findings relative to baseline)
Measured: 48 hours
Safety attributable to [123I] I-(HE)3-G3 injections (ECG) (% of cases with abnormal findings relative to baseline)
The safety attributable to [123I] I-(HE)3-G3 injections will be evaluated based on the assessments of ECG (% of cases with abnormal findings relative to baseline)
Measured: 48 hours
Safety attributable to [123I] I-(HE)3-G3 injections (laboratory tests) (% of cases with abnormal findings relative to baseline)
The safety attributable to [123I] I-(HE)3-G3 injections will be evaluated based on the blood and urine laboratory tests (% of cases with abnormal findings relative to baseline)
Measured: 48 hours
Safety attributable to [123I] I-(HE)3-G3 injections (% of incidence and severity of adverse events)
The safety attributable to [123I] I-(HE)3-G3 injections will be evaluated based on the rate of adverse events (%)
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 posted28 Jun 2023
- Study start1 Sep 2023
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
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
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
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
- Olga Bragina, Dsc, Principal investigator, Tomsk NRMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05923177
- Sponsor's protocol ID
- ORI-30/05/2023-1
- Status last verified
- Jun 2026
- First submitted
- 19 Jun 2023
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPECT Imaging of Human Epidermal Growth Factor Receptor 2 (HER2) Expression in Breast Cancer Using Iodine -123-labelled Designed Ankyrin Repeat Proteins HE3-G3 ([123I] I-(HE)3-G3)
- ClinicalTrials.gov ID
- NCT05923177
- Acronym / sponsor ID
- ORI-30/05/2023-1
- Conditions
- Primary Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of SciencesUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 28 Jun 2023 (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 [123I] I-(HE)3-G3 in patients with primary HER2-positive and HER2-negative breast cancer
Detailed description
Overall goal of the project: To determine HER2 expression level in primary breast cancer before neoadjuvant system therapy.
Phase I. Distribution of HE3-G3 ([123I] I-(HE)3-G3) in patients with primary breast cancer. The study should evaluate distribution of HE3-G3 ([123I] I-(HE)3-G3) in patients with primary HER2-positive and HER2-negative breast cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The tested injected doses of [123I] I-(HE)3-G3 3000 μg | Experimental | Drug: SPECTAt least five (5) evaluable subjects with HER2-positive status and at least five (5) subjects with HER2-negative status have to be enrolled in the study for each tested protein dose. The tested injected dose 3000 μg. 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 (12 listed)
- Subject is > 18 years of age
- Availability of results from HER2 status previously determined on material from the primary tumor and metastatic LN, either a. HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive or b. HER2-negative, defined as a DAKO HercepTest™ score of 0 or 1+; or else if 2+ then FISH negative
- Hematological, liver and renal function test results within the following limits:
- 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
Key exclusion criteria (6 listed)
- Any system therapy (chemo-/targeted therapy)
- Second, non-breast malignancy
- Active current autoimmune disease or history of autoimmune disease
- Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening) 4. 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 |
|---|---|---|
| SPECTAlso: [123I] I-(HE)3-G3One single injection of [123I] I-(HE)3-G3, followed by gamma camera imaging directly postinjection and after 2, 4, 6, 24 and 48 hours. | Drug | The tested injected doses of [123I] I-(HE)3-G3 3000 μg |
Primary outcome
Gamma camera-based whole-body [123I] I-(HE)3-G3 uptake value (%)
Time frame: 6 hours
Whole-body [123I] I-(HE)3-G3 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-G3-(G3S)3C uptake value in tumor lesions (counts) [123I] I-(HE)3-G3 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts
Time frame: 6 hours
SPECT-based [99mTc]Tc-G3-(G3S)3C uptake value in tumor lesions (counts) [123I] I-(HE)3-G3 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts
SPECT-based [123I] I-(HE)3-G3 background uptake value (counts)
Time frame: 6 hours
Focal uptake of [123I] I-(HE)3-G3 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 [123I] I-(HE)3-G3 uptake coinciding with tumor lesions (counts) will be divided by the value of [123I] I-(HE)3-G3 uptake coinciding with the regions without pathological findings (counts)
5 secondary outcomes
Safety attributable to [123I] I-(HE)3-G3 injections (physical examination) (% of cases with abnormal findings relative to baseline)
Time frame: 48 hours
Safety attributable to [123I] I-(HE)3-G3 injections (vital signs) (% of cases with abnormal findings relative to baseline)
Time frame: 48 hours
Safety attributable to [123I] I-(HE)3-G3 injections (ECG) (% of cases with abnormal findings relative to baseline)
Time frame: 48 hours
Safety attributable to [123I] I-(HE)3-G3 injections (laboratory tests) (% of cases with abnormal findings relative to baseline)
Time frame: 48 hours
Safety attributable to [123I] I-(HE)3-G3 injections (% of incidence and severity of adverse events)
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
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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. This study is not recruiting at the moment.
Olga Bragina, Dsc principal investigator
Tomsk NRMC
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 SPECT 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 12 inclusion and 6 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: finished, as of the sponsor's last update on 24 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 [123I] I-(HE)3-G3 uptake value (%) (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 24 Jun 2026.