New PET scan could help doctors see how breast cancer responds to treatment
NCT ID NCT05088785
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study involves 15 postmenopausal women with metastatic ER+ breast cancer. Researchers are testing a special PET scan that uses a radioactive tracer to see estrogen receptors on tumors. The goal is to find the best way to measure these receptors, which could help doctors know if hormone therapy is working. This is an imaging study, not a treatment.
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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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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2021
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- 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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Female participants only
- 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: * Histologically proven metastatic ER+ (\>10% positive stained cells using immunohistochemistry) breast cancer on the latest biopsy * Postmenopausal females aged 18 years or older at screening. Postmenopausal status is defined as one of the following: 1. age ≥60 years 2. age \<60 years and amenorrhea for \>12 months in the absence of interfering hormonal therapies (such as LH-RH agonists and ER-antagonists) 3. patient age \<60 years using LH-RH agonists should continue LH- RH-agonists until after the PET procedures 4. previous bilateral oophorectomy or medically confirmed ovarian failure * \[18F\]FDG PET, CT and/or a bone scan should be performed as part of routine clinical staging (≤4 weeks prior to screening) * Patients should have metastases in the scanning field of view, all located outside of the liver * Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2 * Estimated glomerular filtration rate (eGFR) ≥30 ml/min * Written and signed informed consent Exclusion Criteria: * History with another cancer within the last 5 years, except cancer treated with curative intent and no evidence of disease as judged by the treating physician * Use of selective estrogen receptor modulators (SERMs) or downregulators (SERDs) for current breast cancer such as Tamoxifen/Fulvestrant (≤5 weeks prior to screening) or investigational drug therapy * Pregnancy or lactating women * Any medical, psychological or social condition that may interfere with the subject's safety and participation in the study, will lead to exclusion from this study
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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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Amsterdam UMC - location VUmc
Amsterdam, North Holland, 1081 HV, Netherlands
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