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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a PET/CT scan in detecting the activity of estrogen receptors (ER) in breast cancer that has metastasized. The scan uses an investigational radiotracer called [18F]FES, an imaging agent, to highlight this activity. The trial seeks participants with recurrent or metastatic breast cancer who have previously undergone hormone-based therapy, yet the cancer continues to progress. It may suit individuals with a history of ER+ breast cancer and at least one visible cancer site outside the liver. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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 prior data suggests that this imaging technique is safe for humans?

Research has shown that [18F]fluoroestradiol (FES) is generally safe for use in imaging tests. Some studies report that about 10% of patients experience pain during injection, but no other side effects have been noted. FES is approved in the United States for certain breast cancer imaging, indicating it is well-tolerated by patients. This imaging agent has been studied for over 30 years, providing substantial evidence to support its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional imaging techniques for metastatic breast cancer, which often rely on CT or MRI scans, [18F]FES PET/CT offers a unique approach by using a radiotracer that binds specifically to estrogen receptors. This allows for a more precise visualization of estrogen receptor-positive tumors, potentially leading to better-tailored treatment plans. Researchers are excited about this technique because it provides detailed insights into the tumor biology, which could improve the accuracy of diagnosis and monitoring of treatment response.

What evidence suggests that FES PET/CT imaging is effective for evaluating metastatic breast cancer?

Research has shown that [18F]FES PET/CT, which participants in this trial will receive, effectively identifies estrogen receptor-positive (ER+) areas in breast cancer. This imaging method accurately determines ER status, especially when a tumor sample is unavailable. Studies have found it useful for diagnosing and staging ER+ breast cancer and predicting a patient's response to hormone therapy. Using [18F]FES PET/CT alongside standard tests enhances diagnostic accuracy and can influence treatment choices. Overall, [18F]FES PET/CT provides doctors with a better understanding of the cancer, leading to more personalized and effective treatment plans. ^{1 6 7 8 9}

Who Is on the Research Team?

David Mankoff, MD. PhD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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]

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 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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12110083/

The Role of [18F]FES PET/CT in Breast Cancer Management Our findings consistently demonstrate that [18F]FES PET or PET/CT is highly effective in identifying ER-positive lesions, with sensitivity and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11093585/

Clinical and economic outcomes of adding [18F]FES PET/CT ... Adding [18 F]FES PET/CT to biopsy/IHC may increase the diagnostic accuracy of the ER status, especially when a tumor sample cannot be obtained.

3. ejnmmires.springeropen.com ejnmmires.springeropen.com/articles/10.1186/s13550-025-01205-x

[18F]F-FES PET for diagnosis, staging, and endocrine therapy ... [18F]F-FES PET/CT is valuable for diagnosing and staging ER + breast cancer, assessing ER status, and predicting response to endocrine therapy.

4. journals.plos.org journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0302486&type=printable

Clinical and economic outcomes of adding [18F]FES PET/CT ... The aim of this study was to estimate the budget impact and cost-effectiveness of adding [18F]FES PET/CT to biopsy/IHC in the determination of ...

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

Impact of 18 F-FES PET/CT on Clinical Decisions in the ... The aim of this study was to assess the clinical impact of 18F-FES PET/CT on the management of patients with recurrent or metastatic breast ...

6. 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 ...

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 ER-positive breast ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05088785

Dynamic and Test-retest Whole Body [18F]FES PET ... Participation Criteria · Histologically proven metastatic ER+ (>10% positive stained cells using immunohistochemistry) breast cancer on the latest biopsy.

9. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2020/212155Orig1s000MultidisciplineR.pdf

212155Orig1s000 - accessdata.fda.gov FES has been under clinical investigation as a diagnostic PET imaging agent in patients with breast cancer for more than 30 years (Mintun et al.