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New radioactive tracer could spot breast cancer without a biopsy

NCT ID NCT05203497

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 radioactive tracer called 99mTc-ZHER2:41071 in 30 women with breast cancer. The tracer is designed to attach to HER2 proteins on cancer cells, allowing doctors to see them on a SPECT scan. The goal was to see how the tracer spreads in the body, how safe it is, and whether it can accurately tell HER2-positive from HER2-negative tumors compared to standard biopsy tests.

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-labeled affibody molecule (99mTc-ZHER2:41071)
What this could lead to
If successful, this could lead to a non-invasive imaging method to detect HER2-positive breast cancer, potentially reducing the need for biopsies.
What could go wrong
This is an early phase 1 study with only 30 participants, so results may not apply to all patients. The tracer's safety and accuracy are still being tested.

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.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

30 people

The number who actually took part.

Started

Dec 2021

Finished

Mar 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.

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: 1. Subject is \> 18 years of age 2. Diagnosis of primary breast cancer with possible lymph node metastases 3. Availability of results from HER2 status previously determined on material from the primary tumor, either 1. HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive or 2. HER2-negative, defined as a DAKO HercepTest™ score of 0 or 1+; or else if 2+ then FISH negative 4. 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 5. 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 6. 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 7. Subject is capable to undergo the diagnostic investigations to be performed in the study 8. Informed consent Exclusion Criteria: 1. Second, non-breast malignancy 2. Active current autoimmune disease or history of autoimmune disease 3. 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 5. Administration of other investigational medicinal product within 30 days of screening 6. 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

  • TomskNRMC

    Tomsk, Russia

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