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

2 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial studies use of F-18 16 alpha-fluoroestradiol (\[F-18\] FES) positron emission tomography (PET)/computed tomography (CT) in measuring tumor hormone receptor expression in patients undergoing endocrine-targeted therapy for newly diagnosed breast cancer or breast cancer that has come back or spread to other places in the body. Comparing results of diagnostic procedures done before, during, and after hormone therapy may help measure a patient's response to 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 data supports the effectiveness of the treatment F-18 16 Alpha-Fluoroestradiol for breast cancer?

Research shows that F-18 16 Alpha-Fluoroestradiol (FES) is effective in imaging estrogen receptor-positive breast cancer, helping to select patients for hormone therapies and assess tumors that are hard to biopsy. It has been approved by the FDA for these uses, indicating its effectiveness in managing breast cancer. ^{1 2 3 4 5}

How is hormone receptor imaging different from other breast cancer treatments?

Hormone receptor imaging for breast cancer is unique because it uses PET scans with special tracers like 18F-FES to visualize estrogen and progesterone receptors in tumors. This approach helps in selecting the right patients for hormone therapies, assessing receptor status in hard-to-biopsy lesions, and evaluating unclear imaging results, making it a personalized diagnostic tool. ^{1 2 4 5 6}

Research Team

Hannah Linden, MD

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

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

Clinical Potential of Estrogen and Progesterone Receptor Imaging. [2019]

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

Estrogen Receptor-Targeted and Progesterone Receptor-Targeted PET for Patients with Breast Cancer. [2023]

3. United States 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. [2023]

4. Switzerland 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. [2016]

5. Greece pubmed.ncbi.nlm.nih.gov

The development of estrogen and progestin radiopharmaceuticals for imaging breast cancer. [2016]

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

PET imaging of estrogen receptors as a diagnostic tool for breast cancer patients presenting with a clinical dilemma. [2016]