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New radioactive tracer could spot hidden HER2 cancers

NCT ID NCT05955833

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 pilot study tested a new radioactive tracer called 89Zr-DFO*-trastuzumab in 6 people with HER2-positive breast or gastric cancer. The tracer is designed to attach to HER2 proteins on cancer cells and show up on PET scans. Participants received one injection and had up to 4 PET scans over a week. The goal was to see if the tracer correctly identifies all tumor lesions, which could help guide treatment decisions in the future.

What this could mean

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

Active substance
radioactive tracer (89Zr-DFO*-trastuzumab)
What this could lead to
If successful, this imaging method could help doctors see where HER2-positive tumors are in the body and predict who will benefit from HER2-targeted therapies.
What could go wrong
This is a very small pilot study with only 6 participants, so results may not apply to everyone. The tracer is experimental and its accuracy is 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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

6 people

The number who actually took part.

Started

Jun 2023

Finished

Feb 2025

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 years and older

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: * HER2+ breast cancer with metastatic disease starting (new) systemic treatment or * HER2+ metastatic gastric cancer starting (new) systemic treatment. * A recent (\< 8 weeks of start of study) biopsy confirming HER2+. * Able to undergo PET imaging procedures. * At least one lesion of at least 1.5 cm amenable for PET imaging * Age \>18 years of age, willing and able to comply with the protocol as judged by the investigator. * Signed written informed consent. * Have a World Health Organisation (WHO) performance status of 0-2. * Life expectancy of \> 3 months. * Have measurable disease based on RECIST 1.1. * Adequate organ and bone marrow function, as deemed acceptable by the treating physician * Women aged \<50 years will be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range for the site. * Women aged ≥ 50 years will be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \>1 year ago, had chemotherapy-induced menopause with last menses \>1 year ago. * Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods outlined for women of child-bearing potential if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method. * Female patients of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception from the time of screening and must agree to continue using such precautions for 7 months after the last dose of IMP. * Female patients must refrain from breastfeeding while on study and for 7 months after the last dose of IMP. * Female subjects must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 7 months after the final study drug administration. Exclusion Criteria: * Contraindications for systemic treatment (as will be assigned by treating physician). * Pregnant or lactating women. * Prior allergic reaction to immunoglobulins or immunoglobulin allergy. * Inability to comply with study procedures. * Has substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, interfere with the subject's participation in the clinical study or evaluation of the clinical study results.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • AmsterdamUMC

    Amsterdam, North Holland, 1081 HV, Netherlands

More trials for these conditions

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