NCT06557148 A Study Comparing Cancer Imaging Approaches in People With Lobular Breast Cancer
| NCT ID | NCT06557148 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-08-13 |
| Primary Completion | 2027-08-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2024-08-13 with a primary completion date of 2027-08-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
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.
Contact & Investigator
Somali Gavane, MD
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT06557148 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06557148 currently recruiting?
Yes, NCT06557148 is actively recruiting participants. Contact the research team at GavaneS@mskcc.org for enrollment information.
Where is the NCT06557148 trial being conducted?
This trial is being conducted at Basking Ridge, United States, Middletown, United States, Montvale, United States, Commack, United States and 3 additional locations.
Who is sponsoring the NCT06557148 clinical trial?
NCT06557148 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is Somali Gavane, MD at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 30 participants.
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