What side effects are associated with this type of intervention?

Common treatments for estrogen receptor-positive breast cancer include tamoxifen and aromatase inhibitors. Tamoxifen can cause side effects such as hot flashes, fatigue, and an increased risk of blood clots and endometrial cancer. Aromatase inhibitors, such as anastrozole, can lead to bone density loss, fractures, and cardiovascular risks. Both treatments aim to reduce estrogen's effect on cancer cells but come with their own sets of potential adverse effects.

What prior FDA approvals exist?

FDA-approved treatments for estrogen receptor-positive breast cancer include selective estrogen receptor modulators (SERMs) like tamoxifen, selective estrogen receptor degraders (SERDs) such as fulvestrant, and aromatase inhibitors including letrozole and anastrozole. These therapies target estrogen receptors or inhibit estrogen production, thereby slowing the growth of hormone receptor-positive breast cancer.

What other types of research exist?

Promising novel alternatives to 18F-FES PET/CT for imaging estrogen receptor expression in breast cancer patients include PSMA PET/MRI and advanced MRI techniques. PSMA PET/MRI offers improved soft tissue contrast and detection rates, which may enhance the accuracy of imaging estrogen receptor-positive lesions. Additionally, advanced MRI techniques, such as diffusion-weighted imaging (DWI) and dynamic contrast-enhanced MRI (DCE-MRI), provide detailed tissue characterization and functional information that can complement traditional imaging methods.

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

Phase 4

Recruiting

Led By Jana Ivanidze, MD/PhD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >=18 years

Active diagnosis of ER+ breast cancer (biopsy proven) and new or recurrent brain metastases (biopsy proven or suspected based on MRI appearance)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves imaging procedures rather than drugs, side effects may include discomfort during the scan or reactions related to the contrast agent used (if any), such as mild allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have ER+ breast cancer with new or suspected brain metastases.

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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Distribution volume (Vt) for scan times

Influx (Ki)

Maximum SUV

+3 more

Secondary study objectives

Proportion of cases in which there was a change in management based on FES PET/CT

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for estrogen receptor-positive (ER+) breast cancer include endocrine therapies and targeted treatments. Endocrine therapies, such as tamoxifen and aromatase inhibitors, work by blocking estrogen receptors or reducing estrogen production, thereby inhibiting the growth of cancer cells that rely on estrogen. Targeted treatments, like CDK4/6 inhibitors, work by interfering with specific molecules involved in cancer cell proliferation. Imaging techniques like 18F-FES PET/CT are important as they help visualize estrogen receptor expression, allowing for more precise treatment planning and monitoring of therapy effectiveness. This personalized approach improves outcomes and minimizes unnecessary treatments for breast cancer patients.