New imaging agent could spot hidden breast cancer spread
NCT ID NCT04758780
First seen Jun 27, 2026 · Last updated Jul 21, 2026 · Updated 2 times
Summary
This study tested a new radioactive tracer called 89Zr-TLX250 for PET scans in 12 people with metastatic triple negative breast cancer. The goal was to see if it could find more tumors than the standard FDG PET scan, especially in the brain. Researchers compared the number of lesions detected by each scan to see if the new tracer is more sensitive.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 89Zr-TLX250 (a radioactive tracer for PET scans)
- What this could lead to
- If successful, this could lead to a more accurate imaging method for detecting metastatic triple negative breast cancer, especially in the brain.
- What could go wrong
- This is a small, early-phase study with only 12 participants, so results may not apply to everyone. The new tracer may not prove better than existing scans.
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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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
12 people
The number who actually took part.
- Started
-
Sep 2021
- Finished
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Sep 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 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 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: * Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations. * Female or male, Age ≥ 18 years at time of study entry. * Primitive triple negative breast cancer proven histologically, defined according to the following criteria: * Estrogen receptors \<10%. * And progesterone receptors \<10%. * And Human Epidermal Growth factor Receptor 2 (HER2) not amplified or not overexpressed. * Breast Cancer (BC) recurrence documented by conventional imaging and/or FDG PET/CT with at least one measurable metastatic lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) and/or PET Response Criteria In Solid Tumors (PERCIST). * Consent to use a contraception method for at least 30 days after administration of 89Zr-TLX250. * Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1. * Life expectancy at least 6 months. * Patient has valid health insurance. * Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. Exclusion Criteria: * History of another primary malignancy except for basal cell carcinoma within the last 5 years. * Chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the planned administration of 89Zr-TLX250 or continuing adverse effects (\> grade 1) from such therapy (Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0). * Planned antineoplastic therapies (for the period between IV administration of 89Zr-TLX250 and imaging). * Exposure to murine or chimeric antibodies within the last 5 years. * Previous administration of any radionuclide within 10 half-lives of the same. * Impossibility to hold lying motionless at least 1 hour, or known claustrophobia. * Serious non-malignant disease (e.g. psychiatric, infectious, autoimmune or metabolic), that may interfere with the objectives of the study or with the safety or compliance of the subject, as judged by the investigator. * Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study. * Pregnant or likely to be pregnant or nursing patient. * Known hypersensitivity to girentuximab or desferoxamine. * Renal insufficiency with Glomerular Filtration Rate : GFR ≤ 45 mL/min/ 1.73 m². * Persons deprived of their liberty, under a measure of safeguard of justice, under guardianship or placed under the authority of a guardian. * Disorder precluding understanding of trial information or informed consent.
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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
-
ICO René Gauducheau
Saint-Herblain, 44805, France
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