Hormone Receptor Imaging for Breast Cancer

Overseen By Hannah Linden

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Washington

Must be taking: Endocrine therapy

Must not be taking: Tamoxifen, Faslodex, DES

Disqualifiers: Pregnancy, Cardiac disease, Diabetes, 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: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging technique to assess breast cancer tumors' response to hormone therapy. Using a special scan with F-18 16 Alpha-Fluoroestradiol (also known as 18F-FES or Cerianna), it measures hormone receptor activity in tumors to help doctors evaluate treatment effectiveness. This trial targets individuals diagnosed with hormone-responsive breast cancer, particularly if the cancer has recurred or spread. Participants should have at least one tumor visible with the scan and must be willing to undergo several imaging sessions. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in breast cancer treatment.

Will I have to stop taking my current medications?

The trial requires that you stop taking tamoxifen or other estrogen receptor blocking agents for at least 6 weeks and chemotherapy for 3 weeks before the initial imaging scan.

What prior data suggests that this imaging technique is safe for breast cancer patients?

Research has shown that F-18 16 alpha-fluoroestradiol (F-18 FES) is generally safe for people. The FDA has approved this substance for use in PET scans to help detect certain types of breast cancer. Studies have found that patients usually undergo F-18 FES scans without major problems, and no common serious side effects have been reported. This suggests that F-18 FES is safe for most individuals, although personal experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about F-18 16 Alpha-Fluoroestradiol (F-18 FES) because it offers a unique way to visualize hormone receptor activity in breast cancer through PET/CT imaging. Unlike traditional treatments that focus on reducing tumor size or managing symptoms, F-18 FES provides detailed diagnostic images showing where estrogen receptors are active in the body. This precise imaging can help tailor treatments more effectively, ensuring that therapies are targeted to where they are most needed. By potentially identifying how well a cancer might respond to hormone therapies, F-18 FES could lead to more personalized and effective treatment plans.

What evidence suggests that F-18 FES PET/CT is effective for measuring hormone receptor expression in breast cancer?

Research has shown that F-18 16 alpha-fluoroestradiol (FES) PET/CT scans effectively check estrogen receptor (ER) status in breast cancer patients. In this trial, participants will undergo F-18 FES PET/CT scans to assess ER status, particularly useful for those with recurrent or metastatic cancer. Studies indicate this imaging method can non-invasively determine the extent to which cancer is influenced by estrogen, crucial for planning hormone treatments. The scan provides doctors with a clearer understanding of treatment efficacy. This information helps predict patient response to treatment, making it a valuable tool in managing breast cancer. ^{3 4 6 7 8}

Who Is on the Research Team?

Hannah Linden, MD

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

This trial is for adults with breast cancer that has been confirmed to express hormone receptors and who are about to undergo endocrine therapy. They must not have taken certain medications recently, be able to lie still for scans, and consent to treatment records access. Pregnant individuals or those with uncontrolled diabetes, recent chemotherapy, or weighing over 300 lb cannot participate.

Inclusion Criteria

Patients must be willing to undergo serial imaging procedures.

My breast cancer is ER+ and confirmed by tests on the primary or recurrent tumor.

I am an adult with diagnosed breast cancer, not currently pregnant.

Exclusion Criteria

I am not pregnant, breastfeeding, or able to become pregnant without a negative pregnancy test.

I cannot stay still for tests.

I do not have any serious illnesses besides my cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Imaging

Patients undergo F-18 FES PET/CT scan at baseline to measure initial hormone receptor expression

1 day

1 visit (in-person)

Treatment Imaging

Patients undergo F-18 FES PET/CT and FDG PET/CT between 1-12 weeks after starting therapy to evaluate changes in hormone receptor expression

1-12 weeks

2 visits (in-person)

Follow-up Imaging

Patients undergo a second F-18 FES PET/CT scan 1-12 weeks after the first treatment imaging to further assess changes

1-12 weeks

1 visit (in-person)

Long-term Follow-up

Patients are monitored for disease progression and long-term outcomes

Up to 20 years

What Are the Treatments Tested in This Trial?

Interventions

• F-18 16 Alpha-Fluoroestradiol

Trial Overview [F-18] FES PET/CT scans are being tested to see how well they measure the effect of hormone-targeted therapies on breast cancer by comparing images before, during, and after treatment. The goal is to better understand a patient's response to these therapies.

How Is the Trial Designed?

Group I: Diagnostic (F-18 FES PET/CT) Experimental Treatment 5 Interventions

Patients undergo F-18 FES PET/CT scan at baseline. Patients also undergo F-18 FES PET/CT and FDG PET/CT between 1-12 weeks after starting therapy, and then 1-12 weeks after the second FES PET/CT scan. Repeat FDG PET may be omitted in patients on selective estrogen receptor degrader.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Published Research Related to This Trial

The imaging agent 16α-18F-fluoro-17β-fluoroestradiol (18F-FES) is FDA-approved for use in patients with ER-positive breast cancer, aiding in the selection of appropriate endocrine therapies and assessing ER status in hard-to-biopsy lesions.

There are ongoing clinical trials for new progesterone receptor-targeted imaging agents, indicating a potential expansion of targeted imaging options for breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Estrogen Receptor-Targeted and Progesterone Receptor-Targeted PET for Patients with Breast Cancer. Ulaner, GA., Fowler, AM., Clark, AS., et al.[2023]

Molecular imaging with 16α-[18F]fluoro-17β-estradiol (FES) and 18F-fluoro-furanyl-norprogesterone PET can effectively evaluate the function of steroid hormone receptors in breast cancer, which is crucial for understanding treatment responses.

A current multicenter trial is underway to further validate FES-PET imaging, aiming to enhance its clinical application in predicting prognosis and personalizing endocrine therapy for patients with estrogen receptor-positive tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Potential of Estrogen and Progesterone Receptor Imaging. Linden, HM., Peterson, LM., Fowler, AM.[2019]

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 16 patients with metastatic ER-positive breast cancer, the absence of estrogen receptor expression as measured by [18F]FES PET was a strong predictor of poor response to the treatment with rintodestrant, indicating that monitoring ER expression can guide treatment decisions.

The study found that [18F]FES uptake could effectively monitor the reversible effects of rintodestrant therapy, with no uptake in lesions during treatment suggesting a lack of response, while restoration of uptake after treatment indicated potential for continued therapeutic action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[18F]FDG and [18F]FES PET/CT Imaging as a Biomarker for Therapy Effect in Patients with Metastatic ER+ Breast Cancer Undergoing Treatment with Rintodestrant. Iqbal, R., Yaqub, M., Bektas, HO., et al.[2023]

The estrogen analog 16 alpha-[18F]fluoroestradiol (FES) is an effective imaging agent for detecting estrogen receptor-positive breast tumors, and clinical studies are comparing its effectiveness with the metabolic probe 2-[18F]fluoro-2-deoxyglucose (FDG) in patients undergoing tamoxifen therapy.

Fluorine-18 labeled progestins have shown promising selective distribution in target tissues in animal studies and are ready for human imaging studies, although developing technetium-99m labeled steroids presents unique challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development of estrogen and progestin radiopharmaceuticals for imaging breast cancer. Katzenellenbogen, JA., Welch, MJ., Dehdashti, F.[2016]

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]

Citations

1. 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 ...

2. tech.snmjournals.org tech.snmjournals.org/content/51/3/188

18F-FES Whole-Body Imaging Protocol for Evaluating Tumor ... 18 F-FES WB imaging noninvasively evaluates the ER status of patients with recurrent or metastatic breast cancer.

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

The Role of [18F]FES PET/CT in Breast Cancer Management This umbrella review aims to evaluate the role of 16α-18F-fluoro-17β-estradiol ([18F]FES) PET/CT as a non-invasive imaging tool for assessing ER ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT00602043?term=FLUOROESTRADIOL%20F-18&viewType=Table&rank=9

F-18 16 Alpha-Fluoroestradiol-Labeled Positron Emission ... This phase II trial is studying how well F-18 16 alpha- fluoroestradiol (FES) imaging works in predicting response to first-line hormone therapy in women ...

5. gehealthcare.com gehealthcare.com/about/newsroom/press-releases/ge-healthcare-pharmaco-economic-study-demonstrates-adding-breast-oncology-pet-tracer-to-standard-workup-of-patients-with-metastatic-or-recurrent-breast-cancer-may-yield-beneficial-clinical-and-economic-outcomes-potentially-saving-142m-over-five-years-in-the-us?srsltid=AfmBOooTov9rt2VGXH7qEzNRM3AoHf9umygflBjXyQdb0SjWBm9qqSWr

GE HealthCare Pharmaco-Economic Study Demonstrates ... Adding a PET/CT scan with [ 18 F]FES, a breast oncology PET tracer, may increase the accuracy of knowing the estrogen receptor (ER) status.

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2020/212155s000lbl.pdf

CERIANNA™ (fluoroestradiol F 18) - accessdata.fda.gov The uptake of fluoroestradiol F 18 is not specific for breast cancer and may occur in a variety of ER-positive tumors that arise outside of the breast, ...

7. gehealthcare.com gehealthcare.com/products/molecular-imaging-agents/cerianna?srsltid=AfmBOorx0KER5O_kiNahjcq-1E934kDteaYxQYE3t4BhB7JlDK_pJmtW

Cerianna™ (fluoroestradiol F18) injection Data from a meta-analysis assessed published results comparing F18 fluoroestradiol PET and tissue assays of ER status in patients with BC.1For the primary ...

8. siemens-healthineers.com siemens-healthineers.com/en-us/medical-imaging/molecular-imaging/mi-clinical-corner/scientifc-and-clinical-publications/cerianna-scientific-insight

Fluoroestradiol F 18 - Siemens Healthineers USA Fluoroestradiol F 18 (FES), also known as Cerianna, was approved by the FDA for use in PET imaging for detection of estrogen receptor ...