What this study is
Simplified from ClinicalTrials.govTesting a PET/MRI scan that uses a radioactive imaging agent (18F-FES) to learn whether it can find hidden disease and show how far lobular breast cancer (a type that starts in the breast's milk-producing lobules) has spread, in women 18 and older with this cancer.
Read the original summary from ClinicalTrials.gov
The investigators hope to learn if lobular breast cancer can be identified using a special procedure called a positron emission tomography (PET) magnetic resonance image (MRI) scan, collectively a PET/MRI scan, that uses a radioactive imaging agent called Fluorine 18 fluoroestradiol (18F-FES). This procedure may be able to define the extent of disease more clearly than the standard of care breast imaging exams. 30 participants will be enrolled and be on study for up to 6 months.
What's being tested
- 18Fluoroestradiol (18F-FES)
Intervention · DRUG
* Dose: Approximately 6 millicuries (mCi) (222 megabecquerels (MBq)) ± 20% * Administration: IV injection, contralateral to the primary tumor site * Physical Half-life: ~110 minutes * Mechanism: FES binds to estrogen receptors expressed on tumor cells, enabling visualization of ER-positive disease sites.
- MRI
Intervention · DEVICE
Participant undergoes PET/MRI scan to image ER-positive disease sites
- Gadolinium-based contrast agent (GBCA)
Intervention · DRUG
Administered during the MRI portion of the examination
Study details
- Official title
- A Diagnostic Accuracy Study of FES PET/MRI for the Detection of Occult Disease in Lobular Breast Cancer
- Sponsor
- University of Wisconsin, Madison
- Conditions
- Lobular Breast Carcinoma
- Enrolling
- 30 people
- Starts
- 2026-11
- Est. completion
- 2028-11
- Design
- Open-label, single group, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- Adults assigned female sex at birth
- Newly diagnosed ILC confirmed on core-needle biopsy (greater than or equal to 1 percent ER staining per American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines)
- Have undergone or will undergo standard-of-care (SOC) clinical and imaging assessments (e.g., mammography, ultrasound, breast MRI)
- Planning for mastectomy or breast-conserving surgery within 12 months of their initial diagnosis
- Provision of signed and dated informed consent form
You can't join if
- Patients with history of ipsilateral axillary lymph node dissection
- Patients who received anti-estrogen therapy such as selective estrogen receptor degrader (SERD, e.g., fulvestrant, elacestrant) in the last 28 weeks or selective estrogen receptor modulator (SERM, e.g., tamoxifen, raloxifene) in the last 8 weeks.
- Pregnancy or breastfeeding
- Patients with known allergic or hypersensitivity reactions to previously administered GBCAs or related drug.
- Patients with a contraindication to MRI, or who cannot be positioned within the scanner because their body weight or diameter exceeds the scanner limits.
- Patients requiring intravenous (IV) conscious sedation for imaging are not eligible; patients requiring mild, oral anxiolytics for the clinical MRI will be allowed to participate as long as the following criteria are met:; The subject has their own prescription for the medication; The informed consent process is conducted prior to the self-administration of this medication; They come to the research visit with a driver
- Concurrent participation in another clinical study that, in the judgment of the PI, would interfere with study procedures, endpoint assessment, interpretation of imaging findings, or participant safety.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUW Carbone Cancer Center
Madison, Wisconsin, United States
Study team
Sponsor
University of Wisconsin, Madison
Study ID 2026-1072
Principal investigator
Wenhui Zhou, MD, PhD
UW School of Medicine and Public Health
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.