RecruitingPhase 4interventionalRules rewrite

Phase 4: testing 18Fluoroestradiol (18F-FES) for Lobular Breast Carcinoma

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.

Official registry: https://clinicaltrials.gov/study/NCT07910474 · University of Wisconsin, Madison · enrollment listed as 30

What this phase means

Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are 18Fluoroestradiol (18F-FES), MRI, or Gadolinium-based contrast agent (GBCA). The registry lists allocation as na. 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).

They plan to enroll about 30 people at Madison. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.

Official title (unrewritten)

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

Interventions: 18Fluoroestradiol (18F-FES), MRI, Gadolinium-based contrast agent (GBCA)

Primary outcome (registry wording): Percent of Participants where Disease is Detected using 18F-FES-PET/MRI

Who it is for (from inclusion criteria)

Ages 18 Years to any
Women only
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

Who the registry excludes

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

Public study contact (from the registry)

Cancer Connect

800-622-8922

clinicaltrials@cancer.wisc.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

UW Carbone Cancer Center — Madison, Wisconsin (recruiting)

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FAQ about this NCT record

Is NCT07910474 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07910474?

Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07910474?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary