New scanner aims to spot breast Cancer's true reach
NCT ID NCT05659797
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tests a new imaging device that combines two types of breast scans to see how well it detects estrogen-receptor-positive breast cancer. Up to 20 women with newly diagnosed breast cancer will receive an injection of a radioactive tracer and then be scanned. The results will not be used to guide treatment, but will help researchers understand if this method could improve future cancer imaging.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 18F-Fluoroestradiol (FES)
- What this could lead to
- If successful, this imaging method could help doctors see the full extent of estrogen-receptor-positive breast cancer more clearly, potentially guiding better treatment decisions.
- What could go wrong
- This is a very early pilot study with only 20 people. It is not designed to change treatment yet, and the imaging results are not used for patient care. The device may not prove better than standard methods.
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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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2023
- Expected to finish
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Jan 2028
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: 1. Participants will be ≥ 18 years of age. 2. Known ER positive (by immunohistochemistry) breast cancer. 3. At least one lesion ≥ 1.0 cm that is seen on standard imaging (e.g. mammogram, ultrasound, MRI, CT, FDG-PET/CT). Only one type of imaging is required to show a lesion. 4. Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures. Exclusion Criteria: 1. Females who are pregnant or breast feeding will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential prior to PET imaging.. 2. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician. 3. Currently taking tamoxifen or raloxifene 4. Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the 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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Pennsylvania
RECRUITINGPhiladelphia, Pennsylvania, 19130, United States
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