18F-FES PET/CT Scan for Brain Metastases from Breast Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Weill Medical College of Cornell University
Must not be taking: ER modulators, ER down regulators
Disqualifiers: Pregnancy, Allergy to FES, others
No Placebo Group
Prior Safety Data
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?This trial aims to improve radiation treatment planning for patients with ER-positive breast cancer that has spread to the brain. It uses an additional imaging scan that highlights estrogen receptors in the brain. This helps doctors see where the cancer is more clearly and plan more effective treatments. The new imaging method has shown good results in identifying areas with estrogen receptors.
Will I have to stop taking my current medications?
Yes, you will need to stop taking ER modulators for at least 8 weeks and ER down regulators for at least 28 weeks before participating in the trial.
What data supports the effectiveness of the treatment 18F-FES for brain metastases from breast cancer?
Research shows that 18F-FES PET scans are effective in identifying estrogen receptor-positive breast cancer lesions, including small brain metastases, due to their ability to visualize estrogen receptor-expressing tumors. This imaging technique has been shown to have high sensitivity and specificity in detecting metastatic breast cancer, which can help in the management and treatment planning for patients.
12345Is 18F-FES PET/CT safe for humans?
18F-FES, also known as 18F-Fluoroestradiol, is a radiotracer used in PET scans to detect estrogen receptor-positive breast cancer. It has been widely studied and is generally considered safe for use in humans, as it specifically targets estrogen receptors and has been used in various studies without reported safety issues.
12678How does the 18F-FES PET/CT scan differ from other treatments for brain metastases from breast cancer?
The 18F-FES PET/CT scan is unique because it uses a special radiotracer to visualize estrogen receptor-expressing lesions, which helps in detecting small brain metastases that might be missed by other imaging methods due to the lack of background brain activity. This makes it particularly useful for identifying estrogen receptor-positive metastases in the brain, offering a more targeted approach compared to standard imaging techniques.
12389Eligibility Criteria
This trial is for adults over 18 with ER-positive breast cancer and brain metastases, who are set to receive radiation treatment. Participants must be able to consent, have a life expectancy of at least 6 months, and an ECOG score of 0-1. They should not be allergic to FES, pregnant, or unable to undergo standard care.Inclusion Criteria
Ability to provide informed consent
I stopped taking estrogen receptor modulators 8 weeks ago and down regulators 28 weeks ago.
I am scheduled for radiation treatment for brain cancer spread.
+4 more
Exclusion Criteria
You are allergic to FES.
Pregnancy
I cannot receive standard treatment options.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Diagnostic Intervention
Participants undergo an additional 18F-FES PET/CT scan in addition to their standard of care MRI and FDG PET/CT scan for radiation treatment planning.
2 days to 4 weeks
1 visit (in-person)
Radiation Treatment
Participants receive radiation treatment for brain metastases based on MRI and FES PET/CT data.
Varies per individual treatment plan
Follow-up
Participants are monitored with clinical and MRI assessments per standard-of-care for a total of 12 months.
12 months
Regular visits (in-person)
Participant Groups
The study tests the use of an additional brain scan called [18F]-FES PET/CT in patients already receiving MRI and FDG PET/CT scans as part of their routine care before radiation therapy for brain metastases from estrogen-receptor positive breast cancer.
1Treatment groups
Experimental Treatment
Group I: ER Positive Breast Cancer Patients with Brain MetastasesExperimental Treatment1 Intervention
A diagnostic intervention where this group will undergo an additional 18F- FES PET/CT scan in addition to their standard of care MRI and FDG PET/CT scan.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
New York-Presbyterian/Weill Cornell Medical CenterNew York, NY
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Who Is Running the Clinical Trial?
Weill Medical College of Cornell UniversityLead Sponsor
GE HealthcareIndustry Sponsor
References
18F-FES PET/CT for Characterization of Brain and Leptomeningeal Metastasis in Double Primary Cancer Patient. [2023]The clinical value of 16α-18F-fluoro-17 β-estradiol (18F-FES) PET in breast cancer has been widely investigated because it can visualize estrogen receptor-expressing lesions. This relatively new radiotracer adds clinical values by characterization of metastasis in double primary cancer. It also has advantage in finding small brain lesions, which has no background brain activity. Here, we present 18F-FES PET findings of brain and leptomeningeal metastases in a patient with breast and lung malignancy.
Clinical production, stability studies and PET imaging with 16-alpha-[18F]fluoroestradiol ([18F]FES) in ER positive breast cancer patients. [2016]18F-Fluoroestradiol [18F]FES has emerged as a valuable PET tracer to predict the response to hormone therapy in recurrent or metastatic breast cancer patients. A clinically acceptable product requires a rapid reliable synthesis and must be demonstrated to maintain chemical stability and receptor specific uptake during patient studies. [18F]FES then becomes a dependable tracer for the evaluation and management of breast cancer patients.
Positron tomographic assessment of 16 alpha-[18F] fluoro-17 beta-estradiol uptake in metastatic breast carcinoma. [2016]The positron-emitting estrogenic steroid 16 alpha-[18F]fluoro-17 beta-estradiol (FES) has been shown to exhibit selective uptake in primary breast carcinomas; the uptake of tracer by positron emission tomography (PET) is strongly correlated with the tumor estrogen-receptor concentration. We have now extended the use of this radiopharmaceutical for imaging of metastases of breast carcinoma by PET in 16 patients with clinical or radiographic evidence of metastatic disease. Increased uptake of FES was identified on PET images in 53 of 57 metastatic lesions (93%); only two apparent false-positive foci of FES uptake were seen. In seven of the patients, evaluable PET studies were obtained both before and after initiation of antiestrogen therapy. In all cases, there was a decrease in FES uptake in the tumor deposits after initiation of antiestrogen therapy, and the mean (+/- standard deviation) uptake decreased from 2.22 (+/- 1.23) to 0.80 (+/- 0.42) x 10(3)+ dose/ml. These results indicate that PET with FES has high sensitivity and specificity for detecting metastatic breast carcinoma and provide additional confirmatory evidence that the tumor uptake of this ligand is a receptor-mediated process.
18F-FES PET/CT Influences the Staging and Management of Patients with Newly Diagnosed Estrogen Receptor-Positive Breast Cancer: A Retrospective Comparative Study with 18F-FDG PET/CT. [2020]Label="PURPOSE">We compared the clinical value of 16a-18F-fluoro-17b-estradiol (18F-FES) positron emission tomography (PET)/computed tomography (CT) and 18F-fluoro-2-deoxy-D-glucose (18F-FDG) PET/CT and investigated whether and how 18F-FES PET/CT affects the implemented management of newly diagnosed estrogen receptor positive breast cancer patients.
Quantitative fluoroestradiol positron emission tomography imaging predicts response to endocrine treatment in breast cancer. [2022]In breast cancer, [(18)F]fluoroestradiol (FES) positron emission tomography (PET) correlates with estrogen receptors (ER) expression and predicts response to tamoxifen. We tested the ability of FES-PET imaging to predict response to salvage hormonal treatment in heavily pretreated metastatic breast cancer patients, predominantly treated with aromatase inhibitors.
PET imaging of estrogen receptors as a diagnostic tool for breast cancer patients presenting with a clinical dilemma. [2016]16α-(18)F-fluoro-17β-estradiol ((18)F-FES) is an estrogen receptor (ER)-specific PET tracer with various potential interesting applications. The precise contribution of this technique in current clinical practice, however, has yet to be determined. Therefore, the aim of this study was to evaluate the value of (18)F-FES PET in breast cancer patients presenting with a clinical dilemma.
Diffuse bilateral 18F-Fluoroestradiol pulmonary uptake in patients with metastatic estrogen receptor positive breast cancer: A case report. [2023]Label="INTRODUCTION" NlmCategory="BACKGROUND">Breast cancer is the most commonly diagnosed cancer in women and hormonal therapy is an established treatment for estrogen receptor (ER) positive breast cancers. 18F-Fluoroestradiol (FES) is an emerging radiotracer used to determine hormone status in patients with ER positive breast cancer as FES specifically binds to the alpha subtype of estrogen receptors. As with all radiotracers, FES demonstrates background uptake within various tissues and organs besides the targeted breast cancer and metastatic disease. To date, FES has mostly been shown to demonstrate uptake within the lungs from metastatic disease or in a more focal region after radiation therapy.
Detection of Dural Metastases Before the Onset of Clinical Symptoms by 16α-[18F]Fluoro-17β-Estradiol PET in a Patient With Estrogen Receptor-Positive Breast Cancer. [2023]We offer an illustrative case about estrogen receptor (ER) imaging (also known as 16α-[18F]fluoro-17β-estradiol ([18F]-FES) PET) and the detection of metastatic lesions in the dural region. We present a case of a woman with ER-positive metastatic breast cancer and high [18F]-FES uptake in the dural region on PET imaging, without associated clinical symptoms. These lesions were missed on [18F]-FDG PET because of physiological [18F]-FDG uptake in the brain. This case highlighted some difficulties in the interpretation of imaging of brain metastases and demonstrated the added value of [18F]-FES PET imaging. [18F]-FES PET could be used to prove the presence of ER-positive metastases in the brain.
Molecular Imaging for Estrogen Receptor-Positive Breast Cancer: Clinical Applications of Whole Body and Dedicated Breast Positron Emission Tomography. [2023]18F-fluoroestradiol (18F-FES) is a Food and Drug Administration-approved radiopharmaceutical used for molecular imaging of the estrogen receptor (ER). When combined with PET, 18F-FES may improve the diagnosis of ER-positive breast cancer in the metastatic setting and provide insights into tumor heterogeneity. In this article, we review data on the use of 18F-FES imaging for treatment selection, staging, imaging lobular breast cancer, and the novel breast specific imaging tool, dedicated breast PET.