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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Adenocarcinoma Breast Carcinoma Breast Diseases Breast Neoplasms Carcinoma Carcinoma, Lobular Lobular Breast Carcinoma Metastatic Breast Cancer Metastatic Breast Carcinoma Metastatic Lobular Breast Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

18F-Fluoroestradiol PET/CT

Diagnostic Test

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

Other names: FES PET/CT

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

18F-Fluoroestradiol (FES) Positron Emission Tomography for the Detection and Treatment Response Monitoring in Patients With Metastatic Lobular Breast Carcinoma

Important dates

Study start: 2024
Primary completion: 2027
Study completion: 2027
First posted: Aug 16, 2024
Registry last updated: Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting