About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
18F-Fluoroestradiol PET/CT
Diagnostic testScanned at baseline and again posttreatment within 2 weeks of the restaging FDG PET/CT
Treatment groups
Trial outcomes
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
Disease detection by 18F-FES and 18F-FDG PET/CT images at baseline will be directly compared
Sponsors and contacts
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