Comparing imaging scans for detecting lobular breast cancer
18F-Fluoroestradiol (FES) Positron Emission Tomography for the Detection and Treatment Response Monitoring in Patients With Metastatic Lobular Breast Carcinoma
Memorial Sloan Kettering Cancer Center · NCT06557148
This study is testing which type of imaging scan works better for finding and tracking metastatic lobular breast cancer in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center (other) |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT06557148 on ClinicalTrials.gov |
What this trial studies
This study aims to compare two types of cancer imaging scans to determine which is more effective in detecting and monitoring metastatic invasive lobular carcinoma (ILC). It will evaluate the use of PET/CT scans with the radiotracer 18F-fluoroestradiol (FES) against the standard PET/CT scans using 18F-fluorodeoxyglucose (FDG). The goal is to identify the imaging approach that provides better detection rates and monitoring capabilities for patients with metastatic ILC.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with biopsy-proven metastatic invasive lobular carcinoma and confirmed estrogen receptor-positive breast cancer.
Not a fit: Patients with low estrogen receptor expression or those who have recently undergone certain endocrine therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved imaging techniques that enhance the detection and monitoring of metastatic lobular breast cancer.
How similar studies have performed: Previous studies have shown varying success with different imaging approaches in cancer detection, but this specific comparison of FES and FDG in lobular breast cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (RECRUITING)
- Memorial Sloan Kettering Monmouth (Limited protocol activities) — Middletown, New Jersey, United States (RECRUITING)
- Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale, New Jersey, United States (RECRUITING)
- Memorial Sloan Kettering Suffolk-Commack (All protocol activity) — Commack, New York, United States (RECRUITING)
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States (RECRUITING)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (RECRUITING)
- Memorial Sloan Kettering Nassau (Limited Protocol Activites) — Rockville Centre, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Somali Gavane, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Somali Gavane, MD
- Email: GavaneS@mskcc.org
- Phone: 212-639-2403
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Lobular Breast Carcinoma, Breast Carcinoma, Metastatic Breast Cancer, Metastatic Lobular Breast Carcinoma, Metastatic Breast Carcinoma, breast cancer, lobular breast cancer