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

Recruiting at 27 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

99 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase II trial studies F-18 16 alpha-fluoroestradiol (FES) positron emission tomography (PET)/computed tomography (CT) in predicting response to endocrine therapy in patients with newly diagnosed breast cancer that has spread to other parts of the body. FES is a radioactive form of the hormone estrogen and may "light up" where cancer is in the body. Diagnostic procedures using FES, such as FES PET/CT, may help measure the FES and help doctors predict how well the cancer will respond to treatment.

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.

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

18F-FES, used in PET/CT imaging, is approved by the FDA for evaluating estrogen receptors in breast cancer, indicating it has been deemed safe for human use. It is a radiopharmaceutical, meaning it involves a small amount of radioactive material, but it has been studied in clinical settings for safety. ^{1 2 3 4 5}

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

FES PET/CT imaging is unique because it uses a special tracer, 18F-Fluoroestradiol, to non-invasively measure estrogen receptor activity in breast cancer, helping predict how well a patient might respond to hormone therapy. This approach is different from standard treatments as it provides a personalized assessment of the cancer's hormone sensitivity, which can guide treatment decisions. ^{3 6 7 8 9}

What data supports the effectiveness of this treatment in predicting treatment response in breast cancer?

Research shows that FES PET/CT imaging can predict how well breast cancer patients will respond to hormone therapy by assessing estrogen receptor levels, which are important for determining the effectiveness of treatments like tamoxifen and aromatase inhibitors. ^{3 6 7 8 9}

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]

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]

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 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]

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]

Citations

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

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

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

Positron emission tomography with 2-[18F]Fluoro-2-deoxy-D-glucose and 16alpha-[18F]fluoro-17beta-estradiol in breast cancer: correlation with estrogen receptor status and response to systemic therapy. [2016]

3. 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]

4. 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]

5. 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]

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

PET Imaging of Estrogen Receptors Using 18F-Based Radioligands. [2022]

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

[18F]fluoroestradiol radiation dosimetry in human PET studies. [2016]

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

Molecular Imaging for Estrogen Receptor-Positive Breast Cancer: Clinical Applications of Whole Body and Dedicated Breast Positron Emission Tomography. [2023]

9. United States 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. [2023]