RecruitingNCT07910474ClinicalTrials.gov record

FES PET/MRI for Occult Disease in Lobular Breast Cancer

Lobular Breast Carcinoma

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THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type: Interventional
Phase: Phase 4
Age range: 18 years - Not specified
Sex eligible: Female
Healthy volunteers: Not accepted
Participants: 30 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Read the full description

This prospective study aims to estimate the added value of supplemental 18F-FES PET/MRI following standard-of-care (SOC) preoperative assessments for detecting occult disease in ILC. The investigators hypothesize that there is increased sensitivity of 18F-FES PET/MRI for detecting additional locoregional and distant site(s) of disease that is occult on SOC imaging.

Primary Objective: To estimate the increased sensitivity of 18F-FES PET/MRI for detecting disease that is occult on SOC imaging

Secondary Objectives: To characterize the

Positive predictive value of additional pathology-confirm disease.
Proportion of upstaging (composite T, N and M stages)
Frequency of extensive breast disease (e.g., multifocal, multicentric or contralateral).
Change in clinical management (e.g., changes in treatment intent, conversion to neoadjuvant therapy).
Agreement of ILC tumor size between imaging exams (18F FES PET-MRI and SOC breast MRI, ultrasound and mammogram) and histopathologic exams.
Error rate in size measurements between radiology and pathology for primary ILC.
Change in surgical management (e.g., conversion to mastectomy).

Exploratory objectives: 1) To correlate 18F-FES standardized uptake value of SUVmax with immunohistochemical quantification of ER expression and ILC cellularity. 2) To define an 18F-FES SUVmax threshold for pathology-confirmed ER-positive ILC.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Not applicable
Masking: No masking

Participants with Lobular Breast Cancer

Participants will undergo FES PET/MRI imaging after SOC imaging, followed by SOC breast surgery / biopsy

Drug: 18Fluoroestradiol (18F-FES) · Device: MRI · Drug: Gadolinium-based contrast agent (GBCA)

18Fluoroestradiol (18F-FES) 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 DEVICE

Participant undergoes PET/MRI scan to image ER-positive disease sites

Gadolinium-based contrast agent (GBCA) DRUG

Administered during the MRI portion of the examination

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