18F-FES PET/CT Scan for Brain Metastases from Breast Cancer

Overseen By Alexis Watson

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. ^{1 2 3 4 5}

Is 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. ^{1 2 6 7 8}

How 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. ^{1 2 3 8 9}

Research Team

Jana Ivanidze, MD/PhD

Principal Investigator

Weill Medical College of Cornell University

Eligibility 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.

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)

Treatment Details

Interventions

• 18F-FES (Cancer Imaging)

Trial Overview 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.

Participant Groups

Group I: ER Positive Breast Cancer Patients with Brain Metastases Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

GE Healthcare

Industry Sponsor

Trials

307

Recruited

634,000+

Fotis Vlachos

GE Healthcare

Chief Marketing Officer since 2024

PhD in Molecular Biology and Biochemistry from the University of Massachusetts, MBA from the Wharton School of the University of Pennsylvania

Peter J. Arduini

GE Healthcare

Chief Executive Officer since 2022

MBA from Northwestern University, BSc in Marketing from Susquehanna University

Findings from Research

The 16α-18F-fluoro-17 β-estradiol (18F-FES) PET scan is effective in visualizing estrogen receptor-expressing lesions in breast cancer, enhancing the ability to characterize metastasis in patients with multiple primary cancers.

This imaging technique is particularly beneficial for detecting small brain lesions due to its lack of background brain activity, making it a valuable tool in complex cancer cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-FES PET/CT for Characterization of Brain and Leptomeningeal Metastasis in Double Primary Cancer Patient. Lee, Y., Yoo, IR., Ha, S.[2023]

An improved automated synthesis of the PET tracer 18F-Fluoroestradiol ([18F]FES) has been developed, yielding high radiochemical purity (>99%) and demonstrating stability for up to 24 hours, making it a reliable option for clinical use.

Clinical PET imaging studies show that [18F]FES specifically targets estrogen receptor-positive (ER+) breast cancer tissues, providing clearer delineation of these regions compared to [18F]FDG, which indicates its potential for better predicting hormone therapy responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical production, stability studies and PET imaging with 16-alpha-[18F]fluoroestradiol ([18F]FES) in ER positive breast cancer patients. Kumar, P., Mercer, J., Doerkson, C., et al.[2016]

In a study involving 16 patients with metastatic breast carcinoma, the positron-emitting radiopharmaceutical 16 alpha-[18F]fluoro-17 beta-estradiol (FES) demonstrated a high sensitivity for detecting metastatic lesions, with increased uptake observed in 93% of cases.

After starting antiestrogen therapy, all patients showed a significant decrease in FES uptake in their tumors, confirming that the uptake is receptor-mediated and indicating the effectiveness of the therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positron tomographic assessment of 16 alpha-[18F] fluoro-17 beta-estradiol uptake in metastatic breast carcinoma. McGuire, AH., Dehdashti, F., Siegel, BA., et al.[2016]

In a study of 19 women with newly diagnosed estrogen receptor-positive breast cancer, 18F-FES PET/CT demonstrated a higher sensitivity (90.8%) for detecting lesions compared to 18F-FDG PET/CT (82.8%), indicating its superior diagnostic capability.

The use of 18F-FES PET/CT led to a change in treatment management for 26.3% of patients, highlighting its potential to significantly influence clinical decisions in the management of ER-positive breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Liu, C., Gong, C., Liu, S., et al.[2020]

In a study of 47 patients with ER-positive metastatic breast cancer, quantitative measurements from [(18)F]fluoroestradiol (FES) PET imaging were significantly associated with the response to hormonal therapy, indicating that higher FES uptake (SUV > 1.5) correlated with better treatment outcomes.

Using FES-PET imaging to guide treatment decisions could potentially increase the response rate to hormonal therapy from 23% to 34% overall, and from 29% to 46% in patients without HER2/neu overexpression, suggesting its utility in personalizing breast cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative fluoroestradiol positron emission tomography imaging predicts response to endocrine treatment in breast cancer. Linden, HM., Stekhova, SA., Link, JM., et al.[2022]

In a study involving 33 breast cancer patients, (18)F-FES PET was found to significantly improve diagnostic understanding in 88% of cases and led to changes in therapy for 48% of patients, highlighting its potential as a valuable tool in clinical decision-making.

The (18)F-FES PET tracer was particularly effective in detecting bone metastases, identifying 341 lesions compared to 246 found through conventional imaging, although its sensitivity for liver metastases was limited due to high background activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PET imaging of estrogen receptors as a diagnostic tool for breast cancer patients presenting with a clinical dilemma. van Kruchten, M., Glaudemans, AW., de Vries, EF., et al.[2016]

18F-Fluoroestradiol (FES) is a promising radiotracer for assessing estrogen receptor status in ER positive breast cancer, but it can show diffuse uptake in the lungs due to factors like inflammation or interstitial disease, as seen in two case studies.

In the presented cases, one patient's lung uptake was linked to acute lung injury, while the other had a history of radiation therapy and emphysema, indicating that understanding the context of FES uptake is crucial for accurate interpretation in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diffuse bilateral 18F-Fluoroestradiol pulmonary uptake in patients with metastatic estrogen receptor positive breast cancer: A case report. Phillips, EF., Karak, PK.[2023]

In a case study of a woman with ER-positive metastatic breast cancer, [18F]-FES PET imaging successfully detected metastatic lesions in the dural region that were not visible on [18F]-FDG PET due to overlapping brain activity.

This case demonstrates the potential of [18F]-FES PET as a valuable tool for identifying ER-positive brain metastases, highlighting its efficacy in cases where traditional imaging methods may fail.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Boers, J., Schröder, CP., Hospers, GAP., et al.[2023]

18F-fluoroestradiol (18F-FES) is an FDA-approved radiopharmaceutical that enhances the molecular imaging of estrogen receptors in ER-positive breast cancer, particularly in metastatic cases.

The use of 18F-FES combined with PET imaging can aid in treatment selection and staging, as well as provide valuable insights into tumor heterogeneity and the specific imaging of lobular breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular Imaging for Estrogen Receptor-Positive Breast Cancer: Clinical Applications of Whole Body and Dedicated Breast Positron Emission Tomography. Goodman, K., Abel, MK., Lawhn-Heath, C., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

18F-FES PET/CT for Characterization of Brain and Leptomeningeal Metastasis in Double Primary Cancer Patient. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical production, stability studies and PET imaging with 16-alpha-[18F]fluoroestradiol ([18F]FES) in ER positive breast cancer patients. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Positron tomographic assessment of 16 alpha-[18F] fluoro-17 beta-estradiol uptake in metastatic breast carcinoma. [2016]

4. England pubmed.ncbi.nlm.nih.gov

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]

5. United States pubmed.ncbi.nlm.nih.gov

Quantitative fluoroestradiol positron emission tomography imaging predicts response to endocrine treatment in breast cancer. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

PET imaging of estrogen receptors as a diagnostic tool for breast cancer patients presenting with a clinical dilemma. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Diffuse bilateral 18F-Fluoroestradiol pulmonary uptake in patients with metastatic estrogen receptor positive breast cancer: A case report. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

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]

9. United States pubmed.ncbi.nlm.nih.gov

Molecular Imaging for Estrogen Receptor-Positive Breast Cancer: Clinical Applications of Whole Body and Dedicated Breast Positron Emission Tomography. [2023]