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FES PET/MRI for Occult Disease in Lobular Breast Cancer

RecruitingPhase 4

A Diagnostic Accuracy Study of FES PET/MRI for the Detection of Occult Disease in Lobular Breast Cancer

Who can join

Ages 18 and older · Women

Full eligibility criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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:

  1. The subject has their own prescription for the medication
  2. The informed consent process is conducted prior to the self-administration of this medication
  3. 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.

About the study

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 is being tested

Sponsor: University of Wisconsin, Madison · Participants: 30 · Started: 2026-11

Contact the study team

Official record on ClinicalTrials.gov — NCT07910474

Locations in the U.S.

WisconsinUW Carbone Cancer Center, Madison

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.