Breast CancerNCT06557148
A Study Comparing Cancer Imaging Approaches in People With Lobular Breast Cancer
An observational study of Breast Cancer and Lobular Breast Carcinoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The purpose of this study to compare two types of cancer imaging scans to see which is better at detecting and monitoring metastatic ILC. This study will compare PET/CT (positron emission tomography/computed tomography) scans using the radiotracer fluorine 18 (18F)-fluoroestradiol (FES) with a standard imaging… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Lobular Breast Carcinoma, Breast Carcinoma
- What is being tested?
- 18F-Fluoroestradiol PET/CT
- How many people
- 7 participants
- Where
- 7 sitesUnited States
- Study dates
- 13 Aug 2024to 13 Aug 2027
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited from breast medical oncology clinics, with a concerted effort to recruit a diverse group of patients. Recruitment will be led by Co-PI Komal Jhaveri, MD, Assistant Attending, Breast Medicine Service. Eligible patients will be approached to enroll in the protocol and provide written informed consent. Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at MSK. If the investigator is a member of the treatment team, s/he will screen their patient's medical records for suitable research study participants and discuss the study and their potential for enrolling in the research study.
Who may be able to join
- Adult patient > 18 years old
- Biopsy-proven metastatic ILC
- Confirmed ER+ breast cancer from either primary tumor or metastatic biopsy (ER receptor percent staining ≥ 10% of tumor cells by IHC)
- HER2-negative per ASCO/CAP
- ECOG Performance Status Score of 0, 1 or 2.
- Patient can have received up to 2 lines of therapy in the metastatic setting
- Life expectancy of at least 12 months
Who cannot join
- Low ER expression defined as ER <10% of tumor cells by IHC
- Patients who have been on adjuvant ER-blocking endocrine therapy with SERM or SERD without an 8- and 24-weeks washout, respectively. (The use of aromatase inhibitors or ovarian suppression is permitted given that they do not block estrogen receptors).
- Pregnancy or lactation or parturient or nursing mother
- Patient presents with any other clinically active, serious, life-threatening disease, medical, or psychiatric condition, and/or who has a life expectancy of <12 months, or for whom study participation may compromise their management; and/or a patient who the investigator judges to be unsuitable for participation in the study for any reason.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Suffolk-Commack (All protocol activity)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, 11553
About this study
Official title: 18F-Fluoroestradiol (FES) Positron Emission Tomography for the Detection and Treatment Response Monitoring in Patients With Metastatic Lobular Breast Carcinoma
The purpose of this study to compare two types of cancer imaging scans to see which is better at detecting and monitoring metastatic ILC. This study will compare PET/CT (positron emission tomography/computed tomography) scans using the radiotracer fluorine 18 (18F)-fluoroestradiol (FES) with a standard imaging approach for detecting and monitoring ILC, PET/CT scans using the radiotracer 18F-fluorodeoxyglucose (FDG). These scans will be referred to as FES PET/CT scans and FDG PET/CT scans.
- Conditions
- Breast Cancer, Lobular Breast Carcinoma, Breast Carcinoma, Metastatic Breast Cancer, Metastatic Lobular Breast Carcinoma, Metastatic Breast Carcinoma
- Being tested
- 18F-Fluoroestradiol PET/CT
- Keywords
- breast cancer, lobular breast cancer, lobular breast carcinoma, breast carcinoma, metastatic breast cancer, metastatic lobular breast cancer, metastatic lobular breast carcinoma, metastatic breast carcinoma, 24-134, Memorial Sloan Kettering Cancer Center
- Medical subject headings
- Breast Neoplasms, Carcinoma, Lobular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-Fluoroestradiol PET/CTDiagnostic test
Also called FES PET/CT
Scanned at baseline and again posttreatment within 2 weeks of the restaging FDG PET/CT
| Study group | Role | What they receive |
|---|---|---|
| Biopsy-proven ER+ Metastatic Invasive Lobular Carcinoma/ILC | Participants will have biopsy-proven metastatic ILC, confirmed ER+ breast cancer Receives: Diagnostic Test: 18F-Fluoroestradiol PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of FES PET/CT in Metastatic Invasive Lobular Carcinoma/ILC to standard-of-care (SOC) imaging with FDG PET/CT at baseline
Disease detection by 18F-FES and 18F-FDG PET/CT images at baseline will be directly compared
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start13 Aug 2024
- Primary completion13 Aug 2027 (estimated)
- Study completion13 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Somali Gavane, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557148
- Sponsor's protocol ID
- 24-134
- Status last verified
- Jul 2026
- First submitted
- 13 Aug 2024
- Last updated
- 14 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-Fluoroestradiol (FES) Positron Emission Tomography for the Detection and Treatment Response Monitoring in Patients With Metastatic Lobular Breast Carcinoma
- ClinicalTrials.gov ID
- NCT06557148
- Acronym / sponsor ID
- 24-134
- Conditions
- Breast Cancer, Lobular Breast Carcinoma, Breast Carcinoma, Metastatic Breast Cancer, Metastatic Lobular Breast Carcinoma, Metastatic Breast Carcinoma
- Keywords
- breast cancer, lobular breast cancer, lobular breast carcinoma, breast carcinoma, metastatic breast cancer, metastatic lobular breast cancer, metastatic lobular breast carcinoma, metastatic breast carcinoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 13 Aug 2024 (actual)
- Primary completion
- 13 Aug 2027 (estimated)
- Study completion
- 13 Aug 2027 (estimated)
- First posted
- 16 Aug 2024 (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 purpose of this study to compare two types of cancer imaging scans to see which is better at detecting and monitoring metastatic ILC. This study will compare PET/CT (positron emission tomography/computed tomography) scans using the radiotracer fluorine 18 (18F)-fluoroestradiol (FES) with a standard imaging approach for detecting and monitoring ILC, PET/CT scans using the radiotracer 18F-fluorodeoxyglucose (FDG). These scans will be referred to as FES PET/CT scans and FDG PET/CT scans.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biopsy-proven ER+ Metastatic Invasive Lobular Carcinoma/ILC | – | Diagnostic Test: 18F-Fluoroestradiol PET/CTParticipants will have biopsy-proven metastatic ILC, confirmed ER+ breast cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from breast medical oncology clinics, with a concerted effort to recruit a diverse group of patients. Recruitment will be led by Co-PI Komal Jhaveri, MD, Assistant Attending, Breast Medicine Service. Eligible patients will be approached to enroll in the protocol and provide written informed consent. Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at MSK. If the investigator is a member of the treatment team, s/he will screen their patient's medical records for suitable research study participants and discuss the study and their potential for enrolling in the research study.
Key inclusion criteria (7 listed)
- Adult patient > 18 years old
- Biopsy-proven metastatic ILC
- Confirmed ER+ breast cancer from either primary tumor or metastatic biopsy (ER receptor percent staining ≥ 10% of tumor cells by IHC)
- HER2-negative per ASCO/CAP
- ECOG Performance Status Score of 0, 1 or 2.
Key exclusion criteria (4 listed)
- Low ER expression defined as ER <10% of tumor cells by IHC
- Patients who have been on adjuvant ER-blocking endocrine therapy with SERM or SERD without an 8- and 24-weeks washout, respectively. (The use of aromatase inhibitors or ovarian suppression is permitted given that they do not block estrogen receptors).
- Pregnancy or lactation or parturient or nursing mother
- Patient presents with any other clinically active, serious, life-threatening disease, medical, or psychiatric condition, and/or who has a life expectancy of <12 months, or for whom study participation may compromise their management; and/or a patient who the investigator judges to be unsuitable for participation in the study for any reason.
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 |
|---|---|---|
| 18F-Fluoroestradiol PET/CTAlso: FES PET/CTScanned at baseline and again posttreatment within 2 weeks of the restaging FDG PET/CT | Diagnostic test | Biopsy-proven ER+ Metastatic Invasive Lobular Carcinoma/ILC |
Primary outcome
Comparison of FES PET/CT in Metastatic Invasive Lobular Carcinoma/ILC to standard-of-care (SOC) imaging with FDG PET/CT at baseline
Time frame: 1 year
Disease detection by 18F-FES and 18F-FDG PET/CT images at baseline will be directly compared
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 14 Jul 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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. This study is not recruiting at the moment.
Somali Gavane, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Lobular Breast Carcinoma, run by Memorial Sloan Kettering Cancer Center at 7 sites 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 7 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of FES PET/CT in Metastatic Invasive Lobular Carcinoma/ILC to standard-of-care (SOC) imaging with FDG PET/CT at baseline (time frame: 1 year). 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 14 Jul 2026.