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Breast Cancer FemaleNCT05923268

Molecular Imaging of HER2 Expression in Breast Cancer Using [99mTc]Tc-G3-(G3S)3C Before Chemo/Targeted Therapy

A study testing [99mTc]Tc-G3-(G3S)3C in people with Breast Cancer Female, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study should evaluate distribution of [99mTc]Tc-G3-(G3S)3C 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
Breast Cancer Female
What is being tested?
[99mTc]Tc-G3-(G3S)3C
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
4 Jun 2023to 15 Jun 2024
Phase
Interventional
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.

Russia1 site

  • Olga

    Tomsk

Other trials in Russia

About this study

Official title: SPECT Imaging of Human Epidermal Growth Factor Receptor 2 (HER2) Expression in Breast Cancer Using Technetium-99m-labelled Designed Ankyrin Repeat Proteins ([99mTc]Tc-G3-(G3S)3C)

The study should evaluate distribution of [99mTc]Tc-G3-(G3S)3C 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 (chemotherapy or/and targeted therapy).

Phase I. Distribution of [99mTc]Tc-G3-(G3S)3C in patients with primary breast cancer. The study should evaluate distribution of [99mTc]Tc-G3-(G3S)3C in patients with primary HER2-positive and HER2-negative breast cancer.

Being tested
[99mTc]Tc-G3-(G3S)3C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [99mTc]Tc-G3-(G3S)3CDrug

    One single injection of [99mTc]Tc-G3-(G3S)3C, followed by gamma camera imaging directly postinjection and after 2, 4, 6 and 24 hours

Study groups in NCT05923268
Study groupRoleWhat they receive
The tested injected doses of [99mTc]Tc-G3-(G3S)3C 3000 μgExperimentalAt 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: [99mTc]Tc-G3-(G3S)3C

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gamma camera-based whole-body [99mTc]Tc-G3-(G3S)3C uptake value (%)

    Whole-body [99mTc]Tc-G3-(G3S)3C 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

  2. SPECT-based [99mTc]Tc-G3-(G3S)3C uptake value in tumor lesions (counts) [99mTc]Tc-G3-(G3S)3C 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) [99mTc]Tc-G3-(G3S)3C uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts

    Measured: 6 hours

  3. SPECT-based [99mTc]Tc-G3-(G3S)3C background uptake value (counts)

    Focal uptake of [99mTc]Tc-G3-(G3S)3C in the regions without pathological findings will be assessed with SPECT and measured in counts

    Measured: 6 hours

  4. Tumor-to-background ratio (SPECT)

    The SPECT-based tumor-to-background ratio will be calculated as follows: the value of [99mTc]Tc-G3-(G3S)3C uptake coinciding with tumor lesions (counts) will be divided by the value of [99mTc]Tc-G3-(G3S)3C uptake coinciding with the regions without pathological findings (counts)

    Measured: 6 hours

Secondary outcomes (6)

  1. Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (vital signs) (% of cases with abnormal findings relative to baseline)

    The safety attributable to [99mTc]Tc-G3-(G3S)3C injections will be evaluated based on the assessments of vital signs (% of cases with abnormal findings relative to baseline)

    Measured: 24 hors

  2. Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (physical examination) (% of cases with abnormal findings relative to baseline)

    The safety attributable to [99mTc]Tc-G3-(G3S)3C injections will be evaluated based on the assessments of physical examination (% of cases with abnormal findings relative to baseline)

    Measured: 24 hours

  3. Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (laboratory tests) (% of cases with abnormal findings relative to baseline)

    The safety attributable to [99mTc]Tc-G3-(G3S)3C injections will be evaluated based on the blood and urine laboratory tests (% of cases with abnormal findings relative to baseline)

    Measured: Time Frame: 24 hours

  4. Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (% of incidence and severity of adverse events)

    The safety attributable to [99mTc]Tc-G3-(G3S)3C injections will be evaluated based on the rate of adverse events (%)

    Measured: 24 hours

  5. Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (ECG ) (% of cases with abnormal findings relative to baseline)

    The safety attributable to [99mTc]Tc-G3-(G3S)3C injections will be evaluated based on the assessments of ECG (% of cases with abnormal findings relative to baseline)

    Measured: 24 hours

  6. Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (% concomitant medication)

    The safety attributable to [99mTc]Tc-G3-(G3S)3C 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.

  1. First posted28 Jun 2023
  2. Study start4 Jun 2023
  3. Primary completion15 Jun 2024
  4. Study completion15 Jun 2024

Resources

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 N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05923268
Sponsor's protocol ID
ORI-30/05/2023-2
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

Questions about this trial

What is this clinical trial studying?

A study testing [99mTc]Tc-G3-(G3S)3C 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 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.

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]Tc-G3-(G3S)3C 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?

On the ClinicalTrials.gov record for NCT05923268.

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.

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