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

Overseen By Alexis Watson

Age: 18+

Sex: Female

Trial Phase: Phase 4

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 All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the use of a specific PET/CT scan for individuals with ER-positive breast cancer that has spread to the brain. The study will incorporate an additional 18F-FES PET/CT scan, using the tracer 18F-Fluoroestradiol, before the standard radiation treatment to determine if it enhances radiation planning. Individuals with ER-positive breast cancer and brain metastases scheduled for radiation may qualify, particularly if they have discontinued certain hormone treatments for the required duration. Researchers will monitor participants through regular check-ups and scans for a year to evaluate the effectiveness of the treatment plan. As a Phase 4 trial, this research focuses on understanding how this FDA-approved treatment can benefit more patients.

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 is the safety track record for the 18F-FES PET/CT scan?

Research has shown that the 18F-FES PET/CT scan is generally easy for patients to handle. This imaging method is approved in the United States to help detect estrogen receptor (ER) activity in some cancers, indicating its safety.

Previous studies have not identified any major safety issues, with few reports of adverse side effects. Since this trial uses an imaging technique rather than a new drug, the risks are usually lower. Patients undergoing this scan typically do not experience serious negative effects.

Overall, evidence suggests that the 18F-FES PET/CT scan is safe, particularly for individuals with ER-positive breast cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 18F-FES PET/CT scan for brain metastases from breast cancer because it offers a new way to visualize cancer cells that express estrogen receptors. Unlike standard imaging techniques like MRI and FDG PET/CT, which focus on structural or glucose metabolism details, 18F-FES PET/CT specifically targets estrogen receptors, potentially providing clearer insights into the tumor's behavior. This can help doctors tailor treatments more effectively for patients with estrogen receptor-positive tumors, offering a more personalized approach to managing brain metastases in breast cancer.

What evidence suggests that the 18F-FES PET/CT scan is effective for detecting brain metastases from breast cancer?

Research has shown that the 18F-FES PET/CT scan can effectively detect cancer that has spread to the brain in patients with estrogen receptor (ER) positive breast cancer. In this trial, participants with ER positive breast cancer and brain metastases will undergo an additional 18F-FES PET/CT scan alongside their standard MRI and FDG PET/CT scans. Studies indicate that this scan highlights cancer areas responsive to estrogen, which is common in these patients. This imaging method is more precise in identifying active cancer cells in the brain. Evidence also suggests that the scan can aid doctors in planning and improving radiation treatments by providing a clearer view. Overall, the 18F-FES PET/CT scan is a promising tool for better managing brain metastases in these cases. ^{1 6 7 8 9}

Who Is on the Research Team?

Jana Ivanidze, MD/PhD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• 18F-FES

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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 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 (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 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]

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]

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]

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]

Citations

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[18F]-Fluoroestradiol (FES) brain PET in the evaluation of ... [18F]-Fluoroestradiol (FES) brain PET in the evaluation of patients with estrogen receptor positive breast cancer and known or suspected brain metastases.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0720048X24005072

[18F]-Fluoroestradiol (FES) brain PET in the evaluation of ... [18F]-Fluoroestradiol (FES) brain PET in the evaluation of patients with estrogen receptor positive breast cancer and known or suspected brain metastases.

3. ejradiology.com ejradiology.com/article/S0720-048X(24)00507-2/fulltext

[18F]-Fluoroestradiol (FES) brain PET in the evaluation of ... Our purpose was to describe our initial institutional experience using dedicated brain [18F]-Fluoroestradiol (FES) PET/CT or PET/MRI in the management of ...

4. jnm.snmjournals.org jnm.snmjournals.org/content/66/supplement_1/252264

Dynamic Brain [18F] fluoroestradiol (FES) PET Acquisition ... Introduction: In this study, we assess the optimum scan time window to maximize lesion detectability in estrogen receptor (ER)-positive breast ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8713741/

fluoroestradiol (FES) PET/CT with dedicated brain acquisition ... Dedicated FES brain PET/CT demonstrated significantly increased avidity of the left cerebellar lesion, favoring viable ER-positive neoplasm.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8560320/

Safety and Effectiveness of F-18 Fluoroestradiol Positron ... This systematic literature review and meta-analysis investigated the effectiveness of F-18 FES PET/CT, which can noninvasively confirm ER expression.

7. pubs.rsna.org pubs.rsna.org/doi/abs/10.1148/rg.220143

18F-Fluoroestradiol: Current Applications and Future ... Fluorine 18 fluoroestradiol (FES) PET/CT is approved in the United States as an adjunct to biopsy in patients with recurrent or metastatic ...

8. dctd.cancer.gov dctd.cancer.gov/drug-discovery-development/reagents-materials/imaging-ind-resources/documentation/fes-ib.pdf

Investigator's Brochure [18F]Fluoroestradiol 16α-[18F]-fluoro-17β-estradiol (FES) is a radiolabeled imaging agent that has been used with positron emission tomography (PET) to investigate tumor ...

9. jnm.snmjournals.org jnm.snmjournals.org/content/65/11/1689

Impact of 18 F-FES PET/CT on Clinical Decisions in the ... 18 F-FES PET/CT modified the management of recurrent or metastatic breast cancer, serving as an impactful imaging modality in clinical practice.