18F-FES PET/MRI to find hidden disease in invasive lobular breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional phase 4 trial will evaluate whether adding 18F-FES PET/MRI after standard imaging improves detection of occult disease in invasive lobular carcinoma. Participants will undergo 18F-FES PET/MRI with gadolinium-enhanced MRI alongside usual imaging assessments, and the study will track changes in staging and clinical management. Primary goal is to estimate the increased sensitivity for finding disease not seen on SOC imaging. Secondary aims include evaluating the positive predictive value of new pathology, upstaging frequency, disease extent, changes in treatment or surgery plans, and agreement between imaging and pathology. Exploratory analyses will relate 18F-FES uptake to ER expression and define SUVmax thresholds for ER-positive disease.

Why it matters

Who can join: the full rules

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.

Where it's running

• UW Carbone Cancer Center
  Madison, Wisconsin, United States Recruiting

Study contacts

• Principal investigator: Wenhui Zhou, MD, PhD — UW School of Medicine and Public Health
• Study coordinator: Cancer Connect
• Email: clinicaltrials@cancer.wisc.edu
• Phone: 800-622-8922

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.