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New PET tracer aims to light up HER2 breast cancer

NCT ID NCT06916637

Diagnosis Sponsor: The Affiliated Hospital of Qingdao University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Researchers are testing a new PET imaging tracer called 18F-HER2 Affibody to see how well it detects HER2-expressing breast cancer. The study includes 40 adults with confirmed or suspected HER2-positive breast cancer. Participants receive the tracer and then undergo a PET scan. The goal is to find out if this imaging method can help diagnose, stage, and monitor treatment response for these patients.

What this could mean

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

Active substance
18F-HER2 Affibody PET imaging tracer
What this could lead to
If it works, this tracer could give doctors a clearer picture of HER2 levels in breast cancer, helping them choose targeted treatments and track how well those treatments work.
What could go wrong
This is a small, early-phase imaging study. The tracer may not produce clear enough images, and results might not apply to all breast cancers or patients.

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

About 40 people

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

Started

Apr 2025

Expected to finish

Dec 2027

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.

Who is studied

The study population for this clinical trial consists of adults aged 18 to 75 years with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Participants must have a clinically or pathologically confirmed diagnosis of HER2 expression breast cancer or suspected HER2 expression breast cancer. A life expectancy of at least 12 weeks is required, along with the presence of at least one measurable target lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. All participants of reproductive potential must agree to use effective contraceptive methods throughout the trial and for six months after the last PET scan. Additionally, participants must be able to understand and voluntarily sign the informed consent form，demonstrating good compliance with the study protocol.

Ages

18 to 75 years

Sex

Anyone

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: * Age 18-75 years, ECOG score 0 or 1. * Clinically or pathologically confirmed diagnosis of patients with HER2 expression breast cancer or suspected expression breast cancer. * Life expectancy ≥ 12 weeks. * At least one measurable target lesion according to RECIST 1.1 criteria. * All participants of reproductive potential (regardless of gender) must commit to using effective contraceptive methods throughout the trial participation and for 6 months after the last PET scan. * Ability to understand and voluntarily sign the informed consent form, with good compliance. Exclusion Criteria: * Severe hepatic or renal dysfunction. * Pregnant or lactating women, or women planning to become pregnant. * Inability to lie supine for half an hour. * Refusal to participate in this clinical study. * Suffering from claustrophobia or other mental illnesses. * Other conditions that the investigator deems unsuitable for participation in the trial.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm HER2 positive breast carcinoma

As listed by the trial registrant

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

Breast cancer Breast cancer, HER2-expression

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

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Affiliated Hospital of Qingdao University

    RECRUITING

    Qingdao, Shandong, 266000, China

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