Lobular Breast CarcinomaPhase 4NCT07910474
FES PET/MRI for Occult Disease in Lobular Breast Cancer
A Phase 4 study testing 18Fluoroestradiol (18F-FES), MRI and Gadolinium-based contrast agent (GBCA) in people with Lobular Breast Carcinoma, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lobular Breast Carcinoma
- What is being tested?
- 18Fluoroestradiol (18F-FES), MRI and Gadolinium-based contrast agent (GBCA)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Nov 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
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- The subject has their own prescription for the medication
- The informed consent process is conducted prior to the self-administration of this medication
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Diagnostic Accuracy Study of FES PET/MRI for the Detection of Occult Disease in Lobular Breast Cancer
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.
- Conditions
- Lobular Breast Carcinoma
- Being tested
- 18Fluoroestradiol (18F-FES), MRI, Gadolinium-based contrast agent (GBCA)
- Keywords
- diagnostic, imaging, 18F-FES, invasive lobular cancer
- Medical subject headings
- Carcinoma, Lobular, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18Fluoroestradiol (18F-FES)Drug
Also called 18F-FES, Cerianna, Fluoroestradiol, PET radiopharmaceutical
- 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.
MRIDevice
Also called magnetic resonance imaging, PET/MRI
Participant undergoes PET/MRI scan to image ER-positive disease sites
Gadolinium-based contrast agent (GBCA)Drug
Also called GBCA
Administered during the MRI portion of the examination
| Study group | Role | What they receive |
|---|---|---|
| Participants with Lobular Breast Cancer | Experimental | Participants will undergo FES PET/MRI imaging after SOC imaging, followed by SOC breast surgery / biopsy Receives: Drug: 18Fluoroestradiol (18F-FES); Device: MRI; Drug: Gadolinium-based contrast agent (GBCA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 6 months
Secondary outcomes (7)
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.
Measured: up to 6 months
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.
Measured: up to 6 months
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.
Measured: up to 6 months
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.
Measured: up to 6 months
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.
Measured: up to 6 months
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.
Measured: up to 6 months
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.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lobular Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single-arm diagnostic accuracy study evaluating 18F-FES-PET/MRI for the systemic staging and breast tumor size estimation of newly diagnosed invasive lobular carcinoma (ILC).
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Sponsor
- Investigators
- Wenhui Zhou, MD, PhD, Principal investigator, UW School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910474
- Sponsor's protocol ID
- 2026-1072
- Other IDs
- SMPH | Radiology, Protocol Version 8/14/26, UW26018
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Diagnostic Accuracy Study of FES PET/MRI for the Detection of Occult Disease in Lobular Breast Cancer
- ClinicalTrials.gov ID
- NCT07910474
- Acronym / sponsor ID
- 2026-1072
- Conditions
- Lobular Breast Carcinoma
- Keywords
- diagnostic, imaging, 18F-FES, invasive lobular cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single-arm diagnostic accuracy study evaluating 18F-FES-PET/MRI for the systemic staging and breast tumor size estimation of newly diagnosed invasive lobular carcinoma (ILC).
| Arm | Type | Receives |
|---|---|---|
| Participants with Lobular Breast Cancer | Experimental | Drug: 18Fluoroestradiol (18F-FES), Device: MRI, Drug: Gadolinium-based contrast agent (GBCA)Participants will undergo FES PET/MRI imaging after SOC imaging, followed by SOC breast surgery / biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18Fluoroestradiol (18F-FES)Also: 18F-FES, Cerianna, Fluoroestradiol, PET radiopharmaceutical* 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. | Drug | Participants with Lobular Breast Cancer |
| MRIAlso: magnetic resonance imaging, PET/MRIParticipant undergoes PET/MRI scan to image ER-positive disease sites | Device | Participants with Lobular Breast Cancer |
| Gadolinium-based contrast agent (GBCA)Also: GBCAAdministered during the MRI portion of the examination | Drug | Participants with Lobular Breast Cancer |
Primary outcome
Percent of Participants where Disease is Detected using 18F-FES-PET/MRI
Time frame: up to 6 months
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.
7 secondary outcomes
Participant Level Positive Predictive Value (PPV)
Time frame: up to 6 months
Proportion of Participants Upstaged using a composite of the T, N, and M stages
Time frame: up to 6 months
Proportion of patients who are diagnosed with pathology-proven multifocal, multicentric or contralateral disease
Time frame: up to 6 months
Percent of participants where 18F-FES-PET/MRI changed clinical care compared to SOC image
Time frame: up to 6 months
Lesion-level agreement of the maximal tumor dimension
Time frame: up to 6 months
Lesion-level error rate in maximal tumor dimension
Time frame: up to 6 months
Percent of participants where 18F-FES-PET/MRI changed surgical planning
Time frame: up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wenhui Zhou, MD, PhD principal investigator
UW School of Medicine and Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 18Fluoroestradiol (18F-FES), MRI and Gadolinium-based contrast agent (GBCA) in people with Lobular Breast Carcinoma, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cancer Connect (800-622-8922, clinicaltrials@cancer.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Participants where Disease is Detected using 18F-FES-PET/MRI (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.