New radioactive tracer could spot hidden HER2 cancers
NCT ID NCT05955833
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
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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
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6 people
The number who actually took part.
- Started
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Jun 2023
- Finished
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Feb 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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AmsterdamUMC
Amsterdam, North Holland, 1081 HV, Netherlands
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Other studies related to the condition(s) this trial covers.
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