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Could a single injection replace biopsies for breast cancer?

NCT ID NCT05695859

Diagnosis Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new imaging method that uses a radioactive tracer to detect HER2 protein in breast cancer tumors and nearby lymph nodes. 24 women with primary breast cancer received one injection followed by a scan. The goal was to see if the scan results matched standard tissue tests. If it works, this could offer a less invasive way to check HER2 status.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Technetium-99m-labelled DARPinG3
What this could lead to
If successful, this imaging method could help doctors see HER2 levels in breast cancer tumors without needing a biopsy, making diagnosis faster and less invasive.
What could go wrong
This is a small, early study with only 24 participants, so results may not apply to everyone. The imaging accuracy needs to be confirmed in larger trials.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

24 people

The number who actually took part.

Started

Dec 2022

Finished

Dec 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Breast cancer female patients

Ages

18 to 80 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subject is \> 18 years of age * Diagnosis of primary breast cancer with lymph node metastases * 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; 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm female breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer female

Contacts and locations

Locations

  • Russia Tomsk NRMC

    Tomsk, Russia

More trials for these conditions

Other studies related to the condition(s) this trial covers.