A Study Comparing Cancer Imaging Approaches in People With Lobular Breast Cancer

NCT ID: NCT06557148

Last Updated: 2025-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-13

Study Completion Date

2027-08-13

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Lobular Breast Carcinoma Breast Carcinoma Metastatic Breast Cancer Metastatic Lobular Breast Carcinoma Metastatic Breast Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Biopsy-proven ER+ Metastatic Invasive Lobular Carcinoma/ILC

Participants will have biopsy-proven metastatic ILC, confirmed ER+ breast cancer

18F-Fluoroestradiol PET/CT

Intervention Type DIAGNOSTIC_TEST

Scanned at baseline and again posttreatment within 2 weeks of the restaging FDG PET/CT

Interventions

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18F-Fluoroestradiol PET/CT

Scanned at baseline and again posttreatment within 2 weeks of the restaging FDG PET/CT

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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FES PET/CT

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Somali Gavane, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Suffolk-Commack (All protocol activity)

Commack, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Rockville Centre, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Somali Gavane, MD

Role: CONTACT

212-639-2403

Komal Jhaveri, MD

Role: CONTACT

646-888-5145

Facility Contacts

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Somali Gavane, MD

Role: primary

212-639-2403

Somali Gavane, MD

Role: primary

212-639-2403

Somali Gavane, MD

Role: primary

212-639-2403

Somali Gavane, MD

Role: primary

212-639-2403

Somali Gavane, MD

Role: primary

212-639-2403

Somali Gavane, MD

Role: primary

212-639-2403

Somali Gavane, MD

Role: primary

212-639-2403

Related Links

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http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

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24-134

Identifier Type: -

Identifier Source: org_study_id

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