FES PET/CT Imaging for Metastatic Breast Cancer

Overseen By Erin Schubert

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: University of Pennsylvania

Disqualifiers: Pregnancy, HER2/neu positive, 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

Compensation: Varies

Number of Visits: 1

6 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment [18F]FES for metastatic breast cancer?

Research shows that [18F]FES PET/CT imaging is effective in assessing estrogen receptor expression in breast cancer, which helps predict how well patients might respond to hormonal treatments like tamoxifen. This imaging technique can also influence treatment decisions and management for patients with estrogen receptor-positive breast cancer. ^{1 2 3 4 5}

Is 18F-FES PET/CT imaging safe for humans?

18F-FES PET/CT imaging is generally considered safe for humans, as it is approved by the U.S. Food and Drug Administration for detecting estrogen receptor-positive lesions in breast cancer patients. The studies reviewed did not report any significant safety concerns related to its use. ^{5 6 7 8 9}

How does FES PET/CT imaging differ from other treatments for metastatic breast cancer?

FES PET/CT imaging is unique because it uses a special tracer to visualize estrogen receptor-expressing lesions, which helps in detecting and characterizing metastases in estrogen receptor-positive breast cancer. This method can be more effective than traditional imaging in identifying small lesions, especially in the brain, and can influence treatment decisions by providing detailed information about the cancer's spread. ^{1 5 6 10 11}

What is the purpose of this trial?

In this study, positron emission tomography (PET/CT) imaging will be used to evaluate estrogen receptor (ER) activity in sites of metastatic disease using the investigational radiotracer \[18F\]fluoroestradiol (FES).

Research Team

David Mankoff, MD. PhD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

This trial is for adults with breast cancer that has spread and worsened despite hormone therapy. They must have at least one tumor outside the liver visible on scans, understand the study's experimental nature, and consent to participate. Pregnant women or those with HER2/neu positive cancer are excluded.

Inclusion Criteria

My cancer has returned or spread and is from the breast.

My breast cancer is estrogen receptor positive.

I have cancer that has spread outside the liver, visible on scans.

Exclusion Criteria

I am not pregnant and will take a pregnancy test if I can have children.

My cancer is HER2 positive according to my medical records.

Inability to tolerate imaging procedures in the opinion of an investigator or treating physician

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo [18F]FES PET/CT imaging to evaluate estrogen receptor activity before starting new therapy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for progression free survival and other outcomes over the course of 4 years

4 years

Treatment Details

Interventions

• [18F]FES

Trial Overview [18F]FES PET/CT imaging is being tested to assess estrogen receptor activity in metastatic breast cancer using a new tracer called [18F]fluoroestradiol (FES). The goal is to see how well FES shows ER activity in tumors.

Participant Groups

Group I: FES PET/CT Experimental Treatment 1 Intervention

All subjects will receive an \[18F\]FES PET/CT scan.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Findings from Research

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 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]

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]

18F-FES PET imaging is an FDA-approved diagnostic tool for detecting estrogen receptor-positive lesions in patients with recurrent or metastatic breast cancer, allowing for noninvasive evaluation of ER functionality.

The Society of Nuclear Medicine and Molecular Imaging established appropriate use criteria for 18F-FES PET, highlighting its best applications in assessing ER status in challenging cases and guiding endocrine therapy decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Summary: Appropriate Use Criteria for Estrogen Receptor-Targeted PET Imaging with 16α-18F-Fluoro-17β-Fluoroestradiol. Ulaner, GA., Mankoff, DA., Clark, AS., et al.[2023]

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]

References

1. China pubmed.ncbi.nlm.nih.gov

The clinical value of 18F-fluoroestradiol in assisting individualized treatment decision in dual primary malignancies. [2022]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Safety and Effectiveness of F-18 Fluoroestradiol Positron Emission Tomography/Computed Tomography: a Systematic Review and Meta-analysis. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Comparison of diagnostic sensitivity of [18F]fluoroestradiol and [18F]fluorodeoxyglucose positron emission tomography/computed tomography for breast cancer recurrence in patients with a history of estrogen receptor-positive primary breast cancer. [2020]

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

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

5. 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]

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

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

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

Summary: Appropriate Use Criteria for Estrogen Receptor-Targeted PET Imaging with 16α-18F-Fluoro-17β-Fluoroestradiol. [2023]

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

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

9. England pubmed.ncbi.nlm.nih.gov

Diagnostic accuracy and safety of 16α-[18F]fluoro-17β-oestradiol PET-CT for the assessment of oestrogen receptor status in recurrent or metastatic lesions in patients with breast cancer: a prospective cohort study. [2020]

10. Germany pubmed.ncbi.nlm.nih.gov

Diagnostic effectiveness of [18F]Fluoroestradiol PET/CT in oestrogen receptor-positive breast cancer: the key role of histopathology. Evidence from an international multicentre prospective study. [2023]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Head-to-Head Comparison between 18F-FES PET/CT and 18F-FDG PET/CT in Oestrogen Receptor-Positive Breast Cancer: A Systematic Review and Meta-Analysis. [2022]