FES PET/CT Imaging for Predicting Treatment Response in Breast Cancer

Not currently recruiting at 28 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must be taking: Endocrine therapy

Must not be taking: Molecular targeted therapy

Disqualifiers: Pregnancy, Liver failure, HER2+ disease, 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: 2

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special imaging technique called FES PET/CT can predict breast cancer patients' responses to hormone therapy. FES (F-18 16 Alpha-Fluoroestradiol) is a form of estrogen that highlights cancer locations in the body during imaging. The trial targets patients with newly diagnosed metastatic breast cancer, particularly those with estrogen-sensitive cancer. Suitable candidates include individuals with metastatic breast cancer that tests positive for estrogen receptors and who have not yet received hormone therapy for their metastatic disease. 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 does not specify if you need to stop taking your current medications. However, if you are on blocking adjuvant therapy like tamoxifen, you must stop it at least 60 days before the FES-PET/CT scan.

What prior data suggests that FES PET/CT is safe for predicting treatment response in breast cancer?

Research has shown that F-18 16 alpha-fluoroestradiol (FES) is generally safe for people. FES has already received approval in the United States for use in some breast cancer patients, indicating a good safety record.

FES is a special type of the hormone estrogen used in PET/CT scans to help locate cancer in the body. These scans assist doctors in evaluating how well a treatment might work.

While FES is safe for many, possible side effects may occur. These can include minor reactions to the injection or the radioactive material, though serious side effects are rare.

For those considering joining a trial involving FES, past studies support its safety. Always discuss any concerns with a doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about FES PET/CT imaging because it offers a new way to predict how well a breast cancer patient might respond to endocrine therapy. Unlike traditional imaging techniques, this method uses F-18 16 alpha-fluoroestradiol, which mimics estrogen and can provide detailed information about estrogen receptor activity in tumors. This can potentially help doctors tailor treatment plans more effectively and quickly by identifying which patients are likely to benefit from specific therapies. It represents a promising step toward more personalized and effective breast cancer treatment.

What evidence suggests that FES PET/CT is effective for predicting treatment response in breast cancer?

Research has shown that F-18 16 alpha-fluoroestradiol (FES) PET/CT scans, which participants in this trial will undergo, can help predict breast cancer's response to hormone therapy. This imaging method enhances the visibility of the estrogen receptor (ER) status in tumors. Determining the ER status is crucial for doctors to select the most effective treatment plan. This scan proves especially useful when obtaining a tissue sample from the tumor is challenging. Overall, FES PET/CT improves the accuracy of breast cancer diagnosis, potentially leading to better treatment outcomes. ^{3 4 6 7 8}

Who Is on the Research Team?

Farrokh Dehdashti

Principal Investigator

ECOG-ACRIN Cancer Research Group

Are You a Good Fit for This Trial?

This trial is for postmenopausal women, men, or premenopausal women planning to receive standard endocrine therapy for newly diagnosed metastatic breast cancer that's estrogen-receptor positive. Participants must have a life expectancy over 6 months, be able to lie still for PET/CT scans, and not have received prior endocrine therapy for metastatic disease. They should not be in liver failure or have had more than one line of chemotherapy for metastatic disease.

Inclusion Criteria

My cancer can be seen on scans and is not only in my liver.

Your doctor expects you to live for more than 6 months.

I have no allergies to compounds similar to 18F-FES.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

0-4 weeks

1 visit (in-person)

Diagnostic

Patients receive F-18 16 alpha-fluoroestradiol IV and undergo PET/CT to assess FES uptake

Up to 10 days

1-2 visits (in-person)

Treatment

Patients receive first-line endocrine therapy for metastatic breast cancer

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

Periodic visits

What Are the Treatments Tested in This Trial?

Interventions

• Computed Tomography
• F-18 16 Alpha-Fluoroestradiol
• Positron Emission Tomography

Trial Overview The study tests if F-18 16 alpha-fluoroestradiol (FES) PET/CT can predict the response of metastatic breast cancer to endocrine therapy. FES is a radioactive hormone that highlights cancer in the body during imaging procedures, potentially helping doctors anticipate treatment effectiveness.

How Is the Trial Designed?

Group I: Diagnostic (FES PET/CT) Experimental Treatment 4 Interventions

Between 0 to 30 days before start of endocrine therapy, patients receive F-18 16 alpha-fluoroestradiol IV over 2 minutes and undergo PET/CT. Patients may undergo a second FES-PET/CT study at least 24 hours after the first study and no later than 10 days after the initial study.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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]

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]

18F-FES PET imaging is an FDA-approved method for detecting estrogen receptor alpha (ER+) lesions in patients with recurrent or metastatic breast cancer, providing a non-invasive alternative to biopsy.

This imaging technique allows for the assessment of ER expression and function across multiple metastatic sites, helping to predict responses to endocrine therapy and understand tumor heterogeneity, which is crucial for personalized cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PET Imaging of Estrogen Receptors Using 18F-Based Radioligands. Kumar, M., Salem, K., Jeffery, JJ., et al.[2022]

The PET tracer 16α-18F-fluoro-17β-fluoroestradiol (18F-FES) is FDA-approved and offers a noninvasive method for assessing estrogen receptor status in breast cancer patients, which can help tailor therapy and improve outcomes.

18F-FES, marketed as Cerianna, is now under GE Healthcare's management and is designed to assist oncologists and surgeons in evaluating recurrent tumors and metastatic lesions effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-FES Whole-Body Imaging Protocol for Evaluating Tumor Estrogen Receptor Status in Patients with Recurrent or Metastatic Breast Cancer. Grabher, BJ.[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]

The PET imaging agent [18F]16alpha-fluoroestradiol (FES) is effective for studying estrogen receptors in breast cancer, with a calculated effective dose equivalent of 0.022 mSv/MBq, indicating a low radiation exposure for patients.

The highest radiation dose was received by the liver, but overall, the radiation risks associated with FES imaging are comparable to other common nuclear medicine tests and are considered safe within accepted limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[18F]fluoroestradiol radiation dosimetry in human PET studies. Mankoff, DA., Peterson, LM., Tewson, TJ., et al.[2016]

18F-fluoroestradiol (18F-FES) is an FDA-approved radiopharmaceutical that enhances the molecular imaging of estrogen receptors in ER-positive breast cancer, particularly in metastatic cases.

The use of 18F-FES combined with PET imaging can aid in treatment selection and staging, as well as provide valuable insights into tumor heterogeneity and the specific imaging of lobular breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular Imaging for Estrogen Receptor-Positive Breast Cancer: Clinical Applications of Whole Body and Dedicated Breast Positron Emission Tomography. Goodman, K., Abel, MK., Lawhn-Heath, C., et al.[2023]

Citations

1. pubs.rsna.org pubs.rsna.org/doi/abs/10.1148/rg.220143

18F-Fluoroestradiol: Current Applications and Future ... The breast cancer receptor profile, assessed with immunohistochemical staining of tissue samples, allows prediction of outcomes and direction of ...

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. 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=AfmBOoqslE7OiiEoniob00qPPjbNdEQRE-bbcdA7WKNFvZ3y4pJEFgfF

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.

4. 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.

5. 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 ...

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=AfmBOoryK6Z8OJp3usQ6lQGbm7WYG3UiKDXQylvacPf7Jgogly7Opp1j

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. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2020/212155Orig1s000lbl.pdf

212155Orig1s000 - 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 ...