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Can a new imaging agent light up breast cancer tumors?

NCT ID NCT07784660

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 25, 2026 · Last updated Aug 27, 2026 · Updated 2 times

Summary

This early-stage trial is testing whether a new radioactive imaging agent, called [99mTc]Tc-DARPinEc1-G3C, can safely and effectively visualize breast cancer tumors using SPECT/CT imaging. The study involves about 10 people with primary triple-negative or luminal breast cancer. Participants receive a single injection of the agent, followed by imaging at several time points to see how it distributes in the body and whether it highlights tumors. The goal is to gather initial information on safety, tolerability, and imaging capability.

What this could mean

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

Active substance
a radioactive imaging agent called [99mTc]Tc-DARPinEc1-G3C, given as a single injection
What this could lead to
If successful, this could lead to a new imaging method to better visualize breast cancer tumors, potentially improving detection and treatment planning.
What could go wrong
This is an early-phase trial with only 10 participants, so results may not apply broadly. The imaging agent's safety and effectiveness are still uncertain.

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

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Aug 2028

An estimate. End dates often move.

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. Morphological verification of Breast Cancer T2-4N0-3M0-1 3. Negative HER2 expression in primary tumour tissue according ASCO/CAP 2023 recommendation 4. ECOG 0-2. 5. 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 6. Subject is capable to undergo the diagnostic investigations to be performed in the study 7. Informed consent Exclusion Criteria: 1. Refusal from the study 2. Any system/local treatment 3. Second, non-breast malignancy 4. Active current autoimmune/infection disease or history of autoimmune disease. Known HIV positive or chronically active hepatitis B or C 5. Administration of other investigational medicinal product within 30 days of screening 6. Pregnancy 7. 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 breast tumor luminal A or B triple-negative breast carcinoma

As listed by the trial registrant

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

Primary breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Russia Tomsk NRMC

    Tomsk, Tomsk Reg, 634050, Russia

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