Fluoroestradiol F-18

Fluoroestradiol F-18 is an innovative radiopharmaceutical being studied in clinical trials for its potential to improve treatment decisions in patients with estrogen receptor-positive (ER+), HER2-negative metastatic breast cancer. These trials aim to evaluate how Fluoroestradiol F-18 PET/CT imaging can guide therapy choices and impact patient outcomes after progression on initial hormone therapies.

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What is FLUOROESTRADIOL F-18?

FLUOROESTRADIOL F-18, also known as 18F-FES or 16α-18F-fluoro-17β-oestradiol, is a diagnostic tool used in medical imaging[1]. It’s a radioactive substance that helps doctors see specific areas in your body using a special type of scan called PET/CT (Positron Emission Tomography/Computed Tomography)[2].

How is it used?

FLUOROESTRADIOL F-18 is primarily used to help diagnose and manage a specific type of breast cancer. It works by attaching to estrogen receptors in the body, which are often found in high numbers in certain breast cancers. When used with a PET/CT scan, it can show doctors where these receptors are located, helping them to:

  • Determine if the cancer has spread to other parts of the body
  • Guide treatment decisions
  • Monitor how well the treatment is working

Who can benefit from FLUOROESTRADIOL F-18?

This diagnostic tool is specifically designed for patients with:

  • Metastatic breast cancer: Cancer that has spread from the breast to other parts of the body[1]
  • ER-positive breast cancer: Cancer cells that have estrogen receptors on their surface[1]
  • HER2-negative breast cancer: Cancer cells that don’t have high levels of a protein called HER2[1]

It’s particularly useful for patients who have already undergone initial treatment and are experiencing a relapse or progression of their disease[2].

Current Clinical Trials

FLUOROESTRADIOL F-18 is currently being studied in clinical trials to further understand its benefits. Two notable studies are:

  1. The ECLECTIC Trial: This study is looking at how FLUOROESTRADIOL F-18 PET/CT scans, along with other tests, can help guide treatment decisions for patients whose cancer has progressed after initial therapy[1].
  2. The ESTROTIMP Trial: This trial is investigating how FLUOROESTRADIOL F-18 PET/CT scans might impact treatment management for patients with metastatic breast cancer who have relapsed after their first line of treatment[2].

How is FLUOROESTRADIOL F-18 administered?

FLUOROESTRADIOL F-18 is given as an intravenous injection (into a vein) before a PET/CT scan[1]. The dose is typically measured in units called megabecquerels (MBq), with a maximum dose of about 400 MBq[1]. The exact dose may vary based on your body weight, usually around 4 MBq per kilogram of body weight[2].

Safety Considerations

While FLUOROESTRADIOL F-18 is generally considered safe, there are some important points to consider:

  • It should not be used in patients with known allergies to any of its components[2].
  • It’s not recommended for use in pregnant or breastfeeding women[1].
  • Patients with severe liver or kidney problems may need special consideration[2].
  • As with any medical procedure involving radiation, the benefits should outweigh the potential risks.

Always discuss any concerns or questions with your healthcare provider. They can provide more detailed information based on your specific medical history and condition.

Aspect Details
Drug Name Fluoroestradiol F-18 (EstroTep)
Type of Drug Radiopharmaceutical for PET/CT imaging
Target Patient Population ER-positive, HER2-negative metastatic breast cancer patients who progressed on first-line therapy with CDK4/6 inhibitor and aromatase inhibitor
Primary Objectives Assess the impact of Fluoroestradiol F-18 PET/CT on treatment decisions and evaluate its efficacy in guiding second-line therapy choices
Key Secondary Objectives Evaluate progression-free survival, overall survival, objective response rate, and clinical benefit rate
Administration Intravenous injection, up to 400 MBq
Trial Designs Randomized, multicentric, open-label, phase III and IV studies
Potential Benefits Improved treatment decision-making, potentially leading to better patient outcomes

Ongoing Clinical Trials on Fluoroestradiol F-18

  • Study of elacestrant and exemestane treatment for patients with previously treated hormone receptor-positive, HER2-negative metastatic breast cancer with FES-avid lesions

    Recruiting

    2 1 1 1
    Investigated diseases:
    Italy
  • Study on Using Fluoroestradiol F-18 PET/CT for Detecting Endometriosis in Patients with Pain

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France
  • Study of Fluoroestradiol F-18 and Biomarkers for Women with ER-Positive HER2-Negative Metastatic Breast Cancer After CDK4/6 Inhibitor Therapy

    Recruiting

    3 1 1 1
    Investigated drugs:
    France
  • Study on the Impact of Fluoroestradiol F-18 PET on Treatment for Patients with ER+ HER2- Metastatic Breast Cancer After First-Line Hormone Therapy Relapse

    Not recruiting

    3 1 1 1
    Investigated drugs:
    France

Glossary

  • Estrogen Receptor (ER): A protein found on some breast cancer cells that binds to the hormone estrogen, potentially stimulating cancer growth.
  • HER2: Human Epidermal Growth Factor Receptor 2, a protein that promotes cancer cell growth when overexpressed. HER2-negative means the cancer cells do not have high levels of this protein.
  • Metastatic Breast Cancer: Breast cancer that has spread beyond the breast to other parts of the body.
  • PET/CT: Positron Emission Tomography/Computed Tomography, an imaging technique that combines PET and CT scans to provide detailed pictures of the body's structures and functions.
  • CDK4/6 Inhibitor: A type of targeted therapy used to treat certain types of breast cancer by blocking specific proteins involved in cell division.
  • Aromatase Inhibitor: A type of hormone therapy that lowers estrogen levels in postmenopausal women by blocking the enzyme aromatase.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives without the cancer getting worse.
  • Circulating Biomarkers: Measurable substances in the blood that can indicate the presence or progression of a disease, such as cancer.
  • ECOG Performance Status: A scale used to assess how a patient's disease is progressing and how it affects daily living abilities.
  • SUVmax: Maximum Standardized Uptake Value, a measure used in PET imaging to quantify the concentration of radiotracer in a specific area of the body.

References

  1. http://clinicaltrials.eu/trial/study-of-fluoroestradiol-f-18-and-biomarkers-for-women-with-er-positive-her2-negative-metastatic-breast-cancer-after-cdk4-6-inhibitor-therapy/
  2. http://clinicaltrials.eu/trial/study-on-the-impact-of-fluoroestradiol-f-18-pet-on-treatment-for-patients-with-er-her2-metastatic-breast-cancer-after-first-line-hormone-therapy-relapse/