Breast Cancer FemalePhase 1NCT05203497
Molecular Imaging of HER2 Expression in Breast Cancer Using 99mTc-ZHER2
A Phase 1 study testing SPECT in people with Breast Cancer Female, 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-ZHER2:41071 Affibody molecule in patients with primary HER2-positive and HER2-negative breast cancer The primary objectives are: 1. To assess distribution of 99mTc-ZHER2:41071 in normal tissues and in tumors over time; 2. To evaluate dosimetry of 99mTc-ZHER2:41071; 3. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer Female
- 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
- 30 participants
- Where
- 1 siteRussia
- Study dates
- 22 Dec 2021to 1 Mar 2023
- 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
- Diagnosis of primary breast cancer with possible lymph node metastases
- Availability of results from HER2 status previously determined on material from the primary tumor, either
- HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive or
- HER2-negative, defined as a DAKO HercepTest™ score of 0 or 1+; or else if 2+ then FISH negative
- Volumetrically quantifiable tumour lesions on CT or MRI, with at least one lesion > 2.0 cm in greatest diameter outside of the liver and kidneys
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- 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
- 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
- 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)
- 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 Technetium-99m-labelled Affibody Molecule-based Tracer 99mTc-ZHER2:41071.
The study should evaluate distribution of 99mTc-ZHER2:41071 Affibody molecule in patients with primary HER2-positive and HER2-negative breast cancer
The primary objectives are:
- To assess distribution of 99mTc-ZHER2:41071 in normal tissues and in tumors over time;
- To evaluate dosimetry of 99mTc-ZHER2:41071;
- To obtain initial information concerning safety and tolerability of 99mTc-ZHER2:41071 after single intravenous injection:
The secondary objectives are:
- To compare the tumor imaging data with the data concerning HER2 expression obtained by immunohistochemistry (IHC) and/or fluorescent in situ hybridization (FISH) analysis of biopsy samples.
Read the detailed description
Overall goal of the project: To determine HER2 expression level in primary breast cancer and possibly in axillary lymph node metastases before neoadjuvant targeted (trastuzumab or trastuzumab+pertuzumab) therapy.
Phase I. Distribution of 99mTc-ZHER2:41071 in patients with primary breast cancer.
The study should evaluate distribution of 99mTc-ZHER2:41071 in patients with primary HER2-positive and HER2-negative breast cancer.
The primary objectives are:
- To assess distribution of 99mTc-ZHER2:41071 in normal tissues and in tumors over time;
- To evaluate dosimetry of 99mTc-ZHER2:41071;
- To obtain initial information concerning safety and tolerability of 99mTc-ZHER2:41071 after single intravenous injection:
The secondary objectives are:
- To compare the tumour imaging data with the concerning HER2 expression obtained by immunohistochemistry (IHC) or fluorescent in situ hybridization (FISH) analysis of biopsy samples:
Methodology:
Open-label, exploratory, single center study. The subjects will receive a single injection of the labelled tracer.
- Conditions
- Breast Cancer Female
- Being tested
- SPECT
- Keywords
- 99mTc-ZHER2:41071, Breast Cancer, HER2 expression
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPECTDrug
Also called 99mTc-ZHER2:41071
One single injection of 99mTc-ZHER2:41071, followed by gamma camera imaging after 2, 4, 6 and 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| The tested injected doses of 99mTc-ZHER2:41071 500 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.
Subjects withdrawn from the study for any reason will be replaced. Receives: Drug: SPECT |
| The tested injected doses of 99mTc-ZHER2:41071 1000 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.
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 99mTc-ZHER2:41071 uptake value (% per organ)
Whole-body 99mTc-ZHER2:41071 uptake coinciding with normal organs and tissues will be assessed using gamma camera at 2, 4, 6 and 24 hours after injection and calculated as percentage (%) of the injected dose of the radiopharmaceutical
Measured: 24 hours
SPECT/CT-based 99mTc-ZHER2:41071 uptake value in tumor lesions (kcounts)/SUV
99mTc-ZHER2:41071 focal uptake coinciding with tumor lesions will be assessed using SPECT/CT at 2, 4 and 6 hours after injection and measured in kcounts and SUV
Measured: 6 hours
SPECT-based 99mTc-ZHER2:41071 background uptake value (kcounts)/SUV
Uptake of 99mTc-ZHER2:41071 in the regions without pathological findings will be assessed using SPECT/CT at 2, 4 and 6 hours after injection and measured in kcounts and SUV.
Measured: 6 hours
Tumor-to-background ratio (SPECT)
The SPECT-based tumor-to-background ratio will be calculated as follows: the value of 99mTc-ZHER2:41071 uptake coinciding with tumor lesions (kcounts) will be divided by the value of 99mTc-ZHER2:41071 uptake coinciding with the regions without pathological findings (kcounts)
Measured: 6 hours
Secondary outcomes (7)
Safety attributable to 99mTc-ZHER2:41071 injections (physical examination)
The safety attributable to 99mTc-ZHER2:41071 injections will be evaluated based on the assessments of physical examination (% of cases with abnormal findings relative to baseline)
Measured: 24 hours
Safety attributable to 99mTc-ZHER2:41071 injections (vital signs)
The safety attributable to 99mTc-ZHER2:41071 injections will be evaluated based on the assessments of vital signs (% of cases with abnormal findings relative to baseline)
Measured: 24 hours
Safety attributable to 99mTc-ZHER2:41071 injections (ECG )
The safety attributable to 99mTc-ZHER2:41071 injections will be evaluated based on the assessments of ECG (% of cases with abnormal findings relative to baseline)
Measured: 24 hours
Safety attributable to 99mTc-ZHER2:41071 injections (blood laboratory tests)
The safety attributable to 99mTc-ZHER2:41071 injections will be evaluated based on the blood laboratory tests (% of cases with abnormal findings relative to baseline)
Measured: 24 hours
Safety attributable to 99mTc-ZHER2:41071 injections (urine laboratory tests)
The safety attributable to 99mTc-ZHER2:41071 injections will be evaluated based on the urine laboratory tests (% of cases with abnormal findings relative to baseline)
Measured: 24 hours
Safety attributable to 99mTc-ZHER2:41071 injections (incidence and severity of adverse events)
The safety attributable to 99mTc- ZHER2:41071 injections will be evaluated based on the rate of adverse events (%)
Measured: 24 hours
Safety attributable 99mTc-ZHER2:41071 injections (concomitant medication)
The safety attributable to 99mTc-ZHER2:41071 injections will be evaluated based on the rate of administration of concomitant medication (%)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start22 Dec 2021
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 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
- Vladimir Chernov, MD, Prof., Principal investigator, Tomsk NRMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203497
- Sponsor's protocol ID
- ORI-13
- Status last verified
- Jun 2026
- First submitted
- 30 Dec 2021
- Last updated
- 26 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 26 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 Technetium-99m-labelled Affibody Molecule-based Tracer 99mTc-ZHER2:41071.
- ClinicalTrials.gov ID
- NCT05203497
- Acronym / sponsor ID
- ORI-13
- Conditions
- Breast Cancer Female
- Keywords
- 99mTc-ZHER2:41071, Breast Cancer, HER2 expression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of SciencesUniversity, hospital or other
- Study start
- 22 Dec 2021 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 24 Jan 2022 (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-ZHER2:41071 Affibody molecule in patients with primary HER2-positive and HER2-negative breast cancer
The primary objectives are:
- To assess distribution of 99mTc-ZHER2:41071 in normal tissues and in tumors over time;
- To evaluate dosimetry of 99mTc-ZHER2:41071;
- To obtain initial information concerning safety and tolerability of 99mTc-ZHER2:41071 after single intravenous injection:
The secondary objectives are:
- To compare the tumor imaging data with the data concerning HER2 expression obtained by immunohistochemistry (IHC) and/or fluorescent in situ hybridization (FISH) analysis of biopsy samples.
Detailed description
Overall goal of the project: To determine HER2 expression level in primary breast cancer and possibly in axillary lymph node metastases before neoadjuvant targeted (trastuzumab or trastuzumab+pertuzumab) therapy.
Phase I. Distribution of 99mTc-ZHER2:41071 in patients with primary breast cancer.
The study should evaluate distribution of 99mTc-ZHER2:41071 in patients with primary HER2-positive and HER2-negative breast cancer.
The primary objectives are:
- To assess distribution of 99mTc-ZHER2:41071 in normal tissues and in tumors over time;
- To evaluate dosimetry of 99mTc-ZHER2:41071;
- To obtain initial information concerning safety and tolerability of 99mTc-ZHER2:41071 after single intravenous injection:
The secondary objectives are:
- To compare the tumour imaging data with the concerning HER2 expression obtained by immunohistochemistry (IHC) or fluorescent in situ hybridization (FISH) analysis of biopsy samples:
Methodology:
Open-label, exploratory, single center study. The subjects will receive a single injection of the labelled tracer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The tested injected doses of 99mTc-ZHER2:41071 500 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. Subjects withdrawn from the study for any reason will be replaced. |
| The tested injected doses of 99mTc-ZHER2:41071 1000 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. 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 (16 listed)
- Subject is > 18 years of age
- Diagnosis of primary breast cancer with possible lymph node metastases
- Availability of results from HER2 status previously determined on material from the primary tumor, either
- Volumetrically quantifiable tumour lesions on CT or MRI, with at least one lesion > 2.0 cm in greatest diameter outside of the liver and kidneys
- Hematological, liver and renal function test results within the following limits:
Key exclusion criteria (6 listed)
- 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)
- 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: 99mTc-ZHER2:41071One single injection of 99mTc-ZHER2:41071, followed by gamma camera imaging after 2, 4, 6 and 24 hours. | Drug | The tested injected doses of 99mTc-ZHER2:41071 1000 μg, The tested injected doses of 99mTc-ZHER2:41071 500 μg |
Primary outcome
Gamma camera-based whole-body 99mTc-ZHER2:41071 uptake value (% per organ)
Time frame: 24 hours
Whole-body 99mTc-ZHER2:41071 uptake coinciding with normal organs and tissues will be assessed using gamma camera at 2, 4, 6 and 24 hours after injection and calculated as percentage (%) of the injected dose of the radiopharmaceutical
SPECT/CT-based 99mTc-ZHER2:41071 uptake value in tumor lesions (kcounts)/SUV
Time frame: 6 hours
99mTc-ZHER2:41071 focal uptake coinciding with tumor lesions will be assessed using SPECT/CT at 2, 4 and 6 hours after injection and measured in kcounts and SUV
SPECT-based 99mTc-ZHER2:41071 background uptake value (kcounts)/SUV
Time frame: 6 hours
Uptake of 99mTc-ZHER2:41071 in the regions without pathological findings will be assessed using SPECT/CT at 2, 4 and 6 hours after injection and measured in kcounts and SUV.
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-ZHER2:41071 uptake coinciding with tumor lesions (kcounts) will be divided by the value of 99mTc-ZHER2:41071 uptake coinciding with the regions without pathological findings (kcounts)
7 secondary outcomes
Safety attributable to 99mTc-ZHER2:41071 injections (physical examination)
Time frame: 24 hours
Safety attributable to 99mTc-ZHER2:41071 injections (vital signs)
Time frame: 24 hours
Safety attributable to 99mTc-ZHER2:41071 injections (ECG )
Time frame: 24 hours
Safety attributable to 99mTc-ZHER2:41071 injections (blood laboratory tests)
Time frame: 24 hours
Safety attributable to 99mTc-ZHER2:41071 injections (urine laboratory tests)
Time frame: 24 hours
Safety attributable to 99mTc-ZHER2:41071 injections (incidence and severity of adverse events)
Time frame: 24 hours
Safety attributable 99mTc-ZHER2:41071 injections (concomitant medication)
Time frame: 24 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 26 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.
Vladimir Chernov, MD, Prof. 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 Breast Cancer Female, 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 16 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 26 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 99mTc-ZHER2:41071 uptake value (% per organ) (time frame: 24 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 Jun 2026.