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Not yet recruitingNCT07910474Updated Nov 3, 2026

FES PET/MRI for Occult Disease in Lobular Breast Cancer

A Phase 4 interventional study of 18Fluoroestradiol (18F-FES) and MRI in Lobular Breast Carcinoma, sponsored by University of Wisconsin, Madison. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by University of Wisconsin, Madison · Phase 4, Interventional, and Diagnostic

Updated Nov 3, 2026Eligibility revisedPrimary outcomes revised+2 moreGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Lobular Breast Carcinoma

Keywords

  • diagnostic
  • imaging
  • 18F-FES
  • invasive lobular cancer
03

In context

Carcinoma, Lobular

67 studies on the registry are indexed under Carcinoma, Lobular; 17 are open to participants now.

This study's planned enrollment of 30 is below the median of 58 across 50 interventional studies indexed under Carcinoma, Lobular.

Browse Carcinoma, Lobular studies →

Lead sponsor

University of Wisconsin, Madison is the lead sponsor of 1,187 studies on the registry; 182 are open to participants now.

Of its 157 completed or terminated interventional studies of FDA-regulated products, 118 (75%) have results posted.

Browse University of Wisconsin, Madison studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Nov 3, 2026. See what changed

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    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)

Interventions

  • Drug18Fluoroestradiol (18F-FES)

    * 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.

    Also known as: 18F-FES, Cerianna, Fluoroestradiol, PET radiopharmaceutical

  • DeviceMRI

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

    Also known as: magnetic resonance imaging, PET/MRI

  • DrugGadolinium-based contrast agent (GBCA)

    Administered during the MRI portion of the examination

    Also known as: GBCA

06

What researchers measure

Primary outcomes

  1. Percent of Participants where Disease is Detected using 18F-FES-PET/MRI

    The number of participants for which disease is detected using 18F-FES-PET/MRI compared to the number of samples identified with disease (histopathology) will be reported to estimate the sensitivity of 18F-FES-PET/MRI for detecting disease that is occult (hidden) on SOC imaging.

    Time frame: up to 6 months

Secondary outcomes

  1. Participant Level Positive Predictive Value (PPV)

    Defined by histopathology as the reference standard. This is the odds of 18F-FES-PET/MRI imaging predicting disease.

    Time frame: up to 6 months

  2. Proportion of Participants Upstaged using a composite of the T, N, and M stages

    A cancer is staged by describing the: the size of the Tumor, whether the cancer has spread to lymph Nodes, and whether the cancer has spread to other organs, or Metastasized (TNM staging). TNM upstaging is when a patient is discovered to have more advanced cancer than initially imaging.

    Time frame: up to 6 months

  3. Proportion of patients who are diagnosed with pathology-proven multifocal, multicentric or contralateral disease

    The proportion of patients who are diagnosed with pathology-proven multifocal, multicentric or contralateral disease will be measured to characterize the frequency of the detection of extensive breast involvement by 18F-FES-PET/MRI.

    Time frame: up to 6 months

  4. Percent of participants where 18F-FES-PET/MRI changed clinical care compared to SOC image

    The following will be reviewed: frequency of changes in treatment intent from curative to palliative after detecting occult metastatic disease; conversion to neoadjuvant therapy after detecting occult locally advanced disease; and changes in axillary surgery from sentinel lymph node biopsy to targeted axillary dissection or complete axillary lymph node dissection after detecting occult axillary metastases in order to characterize the clinical impact of 18F-FES-PET/MRI on treatment decision.

    Time frame: up to 6 months

  5. Lesion-level agreement of the maximal tumor dimension

    The lesion-level agreement of the maximal tumor dimension for the indexed ILC lesion, comparing imaging measurements with pathology measurements among patients who underwent definitive surgery will be reported to characterize the agreement of ILC tumor size between imaging exams (18F FES PET-MRI and SOC breast MRI, ultrasound and mammogram) and histopathologic exams.

    Time frame: up to 6 months

  6. Lesion-level error rate in maximal tumor dimension

    The lesion-level error rate in maximal tumor dimension using pre-specified relative threshold of less than or equal to 25 percent difference between imaging and pathology measurements will be reported to characterize the error rate in size measurements between radiology and pathology for primary ILC.

    Time frame: up to 6 months

  7. Percent of participants where 18F-FES-PET/MRI changed surgical planning

    The frequency of changed surgical planning (conversion from planned lumpectomy to mastectomy due to extensive breast involvement; margin re-excision in those undergoing lumpectomy; conversion to mastectomy in those initially managed with lumpectomy) will be reported to characterize the clinical impact of 18F-FES-PET/MRI on surgical planning.

    Time frame: up to 6 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for Nov 2028, 24 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 26, 2026
First posted
Nov 2, 2026
StartEst.
Nov 2026
Primary completionEst.
Nov 2028
CompletionEst.
Nov 2028
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Eligibility
1 inclusion criterion edited
What changed in the criteria
Inclusion criteria
  • EditedNewly 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)
Nov 3, 2026
Interventions
Changed Gadolinium-based contrast agent→Gadolinium-based contrast agent (GBCA)
Nov 3, 2026
Primary outcomes
1 description edited
What changed in the outcomes
  • DescriptionPercent of Participants where Disease is Detected using 18F-FES-PET/MRI: how it is measured was reworded
Nov 3, 2026
Secondary outcomes
5 description edited
What changed in the outcomes
  • DescriptionLesion-level agreement of the maximal tumor dimension: how it is measured was reworded
  • DescriptionLesion-level error rate in maximal tumor dimension: how it is measured was reworded
  • DescriptionPercent of participants where 18F-FES-PET/MRI changed clinical care compared to SOC image: how it is measured was reworded
  • DescriptionPercent of participants where 18F-FES-PET/MRI changed surgical planning: how it is measured was reworded
  • DescriptionProportion of patients who are diagnosed with pathology-proven multifocal, multicentric or contralateral disease: how it is measured was reworded
Nov 3, 2026
Registered
First appeared on the registry
Nov 2, 2026
Show all 2 updates
  1. Nov 3, 2026
    Eligibility 1 inclusion criterion edited
    What changed in the criteria
    Inclusion criteria
    • EditedNewly 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)
    Primary outcomes 1 description edited
    What changed in the outcomes
    • DescriptionPercent of Participants where Disease is Detected using 18F-FES-PET/MRI: how it is measured was reworded
    Secondary outcomes 5 description edited
    What changed in the outcomes
    • DescriptionLesion-level agreement of the maximal tumor dimension: how it is measured was reworded
    • DescriptionLesion-level error rate in maximal tumor dimension: how it is measured was reworded
    • DescriptionPercent of participants where 18F-FES-PET/MRI changed clinical care compared to SOC image: how it is measured was reworded
    • DescriptionPercent of participants where 18F-FES-PET/MRI changed surgical planning: how it is measured was reworded
    • DescriptionProportion of patients who are diagnosed with pathology-proven multifocal, multicentric or contralateral disease: how it is measured was reworded
    Interventions Changed Gadolinium-based contrast agent→Gadolinium-based contrast agent (GBCA)
  2. Nov 2, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07910474
Lead sponsor
University of Wisconsin, Madison
Collaborators
GE Healthcare
Responsible party
Sponsor
First posted
Nov 2, 2026
Start date
Nov 2026 (estimated)
Primary completion
Nov 2028 (estimated)
Completion
Nov 2028 (estimated)
Last update
Nov 3, 2026

Study contacts

Cancer Connect
Contact
clinicaltrials@cancer.wisc.edu
800-622-8922
Wenhui Zhou, MD, PhD
principal investigator · UW School of Medicine and Public Health

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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