Actively Recruiting

Age: 18Years +
All Genders
ID06557148

18F-Fluoroestradiol (FES) PET for Detection and Monitoring of Metastatic Lobular Breast Carcinoma

Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-02-27

30

Participants Needed

7

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are comparing two types of PET/CT scans to determine which is better at detecting and monitoring metastatic invasive lobular carcinoma (ILC), a type of breast cancer that is estrogen receptor positive (ER+). The study focuses on evaluating the use of fluorine 18 (18F)-fluoroestradiol (FES) PET/CT scans versus the standard 18F-fluorodeoxyglucose (FDG) PET/CT scans in people with metastatic ILC. The goal is to improve imaging methods for this specific breast cancer type, with support from Memorial Sloan Kettering Cancer Center. Participants will undergo FES PET/CT scans at the start of the study and again after treatment, within two weeks of their follow-up FDG PET/CT scans. Both types of scans will be compared to assess their effectiveness in detecting and monitoring metastatic disease. The study includes patients with biopsy-confirmed metastatic ER+ lobular breast cancer who meet specific health and treatment history criteria. During the study, participants will have both FES and FDG PET/CT scans at baseline and after treatment to monitor cancer status. Researchers will compare results from these imaging tests over a one-year period to evaluate which method provides better information about the cancer. Participants' health status, performance ability, and prior treatments are monitored to ensure safety. The study aims to gather important data to guide future imaging choices for metastatic lobular breast cancer.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patient over 18 years old
  • Biopsy-proven metastatic invasive lobular carcinoma
  • Confirmed estrogen receptor positive breast cancer with at least 10% tumor cells staining by immunohistochemistry
  • HER2-negative status according to ASCO/CAP guidelines
  • ECOG Performance Status Score of 0, 1, or 2
  • May have received up to 2 lines of therapy in the metastatic setting
  • Life expectancy of at least 12 months
Not Eligible

You will not qualify if you...

  • Low estrogen receptor expression defined as less than 10% tumor cells by immunohistochemistry
  • Use of adjuvant ER-blocking endocrine therapy with SERM or SERD without required washout periods
  • Pregnancy, lactation, or currently nursing
  • Presence of any other serious, life-threatening medical or psychiatric condition
  • Life expectancy less than 12 months
  • Investigator judgment deeming participant unsuitable for study participation for any reason

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Baseline and posttreatment within 2 weeks of restaging

Participants undergo imaging scans to detect and monitor metastatic lobular breast carcinoma using 18F-Fluoroestradiol PET/CT and standard FDG PET/CT.

2 visits (in-person)

Long-term Monitoring

Duration - 1 year

Participants are observed to compare imaging outcomes over 1 year.

Visits as per standard care

Trial Site Locations

Total: 7 locations

1

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States, 07920

Actively Recruiting

2

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, United States, 07748

Actively Recruiting

3

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, United States, 07645

Actively Recruiting

4

Memorial Sloan Kettering Suffolk-Commack (All protocol activity)

Commack, New York, United States, 11725

Actively Recruiting

5

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States, 10604

Actively Recruiting

6

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States, 10065

Actively Recruiting

7

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Rockville Centre, New York, United States, 11553

Actively Recruiting

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Research Team

S

Somali Gavane, MD

K

Komal Jhaveri, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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