NCT07910474 FES PET/MRI for Occult Disease in Lobular Breast Cancer
| NCT ID | NCT07910474 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Wisconsin, Madison |
| Condition | Lobular Breast Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-11 |
| Primary Completion | 2028-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 30 participants in total. It began in 2026-11 with a primary completion date of 2028-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Wenhui Zhou, MD, PhD
PRINCIPAL INVESTIGATOR
UW School of Medicine and Public Health
Frequently Asked Questions
Who can join the NCT07910474 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Lobular Breast Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07910474 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07910474 currently recruiting?
Yes, NCT07910474 is actively recruiting participants. Contact the research team at clinicaltrials@cancer.wisc.edu for enrollment information.
Where is the NCT07910474 trial being conducted?
This trial is being conducted at Madison, United States.
Who is sponsoring the NCT07910474 clinical trial?
NCT07910474 is sponsored by University of Wisconsin, Madison. The principal investigator is Wenhui Zhou, MD, PhD at UW School of Medicine and Public Health. The trial plans to enroll 30 participants.