FES-PET/CT Imaging for Breast Cancer

Overseen By Regan Butterfield Schuchart

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Utah

Must be taking: Antihormonal therapy

Must not be taking: Estrogen receptor agonists

Disqualifiers: Pregnancy, Breastfeeding, Medically unstable, 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 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

44 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

If you are taking estrogen receptor agonists like fulvestrant or tamoxifen, you must stop them at least 5 weeks before the FES-PET/CT scan. However, if you are on aromatase inhibitors or luteinizing hormone-releasing hormone agonists, you do not need to stop them. If you are in Exploratory Arm 1, you can continue your current antihormonal therapy or chemotherapy.

What data supports the idea that FES-PET/CT Imaging for Breast Cancer is an effective treatment?

The available research shows that FES-PET/CT Imaging is effective for breast cancer because it helps doctors see how much of the cancer is affected by estrogen, which is important for choosing the right treatment. This imaging method is especially useful for patients with metastatic breast cancer, where the cancer has spread to other parts of the body. It helps in predicting how well a patient might respond to hormone therapy, which is a common treatment for this type of cancer. Compared to other methods, FES-PET/CT provides a noninvasive way to evaluate the cancer, making it safer and more comfortable for patients. This imaging technique is also approved by the U.S. Food and Drug Administration, which supports its effectiveness and reliability. ^{1 2 3 4 5}

What safety data exists for FES-PET/CT imaging in breast cancer treatment?

18F-FES, also known as Cerianna, is a PET imaging agent approved by the FDA for evaluating estrogen receptor status in breast cancer. It has been used in clinical studies to assess ER expression and predict therapy response. The safety data is primarily derived from its FDA approval process, which indicates it is considered safe for use in imaging ER-positive breast cancer. The package insert and imaging protocols provide guidelines for its safe application. ^{1 4 6 7 8}

Is FES-PET/CT Imaging a promising treatment for breast cancer?

FES-PET/CT Imaging is a promising tool for breast cancer because it helps doctors see how much estrogen receptor is in the cancer. This can improve diagnosis and help choose the best treatment for patients with estrogen receptor-positive breast cancer. ^{1 3 9 10 11}

What is the purpose of this trial?

FES PET/CT imaging for invasive lobular cancer

Research Team

Jeffrey Yap, PhD

Principal Investigator

Huntsman Cancer Institute/ University of Utah

Eligibility Criteria

This trial is for adults with invasive lobular carcinoma of the breast, confirmed within the past 12-16 weeks. Participants must be willing to provide blood samples and have their medical records reviewed. It's not for those who've had certain estrogen treatments recently, are pregnant or breastfeeding, or have severe allergies/autoimmune diseases.

Inclusion Criteria

Patient is willing to have their clinical records reviewed, and be contacted by phone during follow-up intervals specified, for approximately 60 months after enrollment

My cancer is ER- and has spread from the lobular area.

My cancer is ER+ and was confirmed by a biopsy within the last 16 weeks.

Exclusion Criteria

I had surgery to remove invasive lobular carcinoma.

I am not currently hospitalized or in need of urgent care.

You need special anesthesia monitoring for a PET/CT scan.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Session

Participants undergo one session of [18F]FES PET/CT Imaging, with optional [18F]FDG PET/CT scan and optional follow-up [18F]FES PET/CT exam

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

Up to 60 months

Treatment Details

Interventions

• [18F]Fluoroestradiol (FES) PET/CT

Trial Overview [18F]Fluoroestradiol (FES) PET/CT imaging is being tested on patients with invasive lobular carcinoma to see how well it detects cancer spread and monitors treatment response over time.

Participant Groups

Group I: Pilot Phase Experimental Treatment 1 Intervention

Subjects with biopsy-proven invasive lobular carcinoma (ILC), diagnosed within 12 weeks of imaging, confirmed from biopsy of primary tumor or metastasis, will undergo one Fluorine-18 (18F) -Fluoroestradiol (FES) positron emission tomography/computed tomography (PET/CT) scan and one optional 18F-fluorodeoxyglucose (FDG) PET/CT(if a standard of care scan not already performed). For the FES scan, patients are administered a dose of approximately 6 millicurie (mCi) and imaged approximately 60 minutes after injection. For the FDG scan, patients are administered a dose of approximately 15 mCi and imaged approximately 60 minutes after injection.

Group II: Expansion Phase Experimental Treatment 1 Intervention

Subjects with histologically confirmed estrogen receptor positive (ER+) invasive lobular carcinoma (ILC), diagnosed within 16 weeks of imaging, confirmed from biopsy of primary tumor or metastasis, will undergo one 18F-Fluoroestradiol (FES) PET/CT scan, one optional 18F-FDG PET/CT (if a standard of care scan not already performed), and one optional follow-up FES-PET/CT. For the FES scan, patients are administered a dose of approximately 6 mCi and imaged approximately 60 minutes after injection. For the FDG scan, patients are administered a dose of approximately 15 mCi and imaged approximately 60 minutes after injection.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Findings from Research

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]

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]

18F-FES PET imaging is an FDA-approved diagnostic tool for detecting estrogen receptor-positive lesions in patients with recurrent or metastatic breast cancer, allowing for noninvasive evaluation of ER functionality.

The Society of Nuclear Medicine and Molecular Imaging established appropriate use criteria for 18F-FES PET, highlighting its best applications in assessing ER status in challenging cases and guiding endocrine therapy decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Summary: Appropriate Use Criteria for Estrogen Receptor-Targeted PET Imaging with 16α-18F-Fluoro-17β-Fluoroestradiol. Ulaner, GA., Mankoff, DA., Clark, AS., 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]

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 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 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]

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]

In a study of 312 FES PET scans from 239 patients with ER+ primary breast cancer, sex hormone-binding globulin (SHBG) was found to inversely affect FES uptake, indicating its importance in assessing estrogen receptor expression.

The study suggests that FES uptake can be reliably measured by adjusting for lean body mass (LBM), and that pre-menopausal estradiol levels do not significantly impact FES uptake, allowing for simplified imaging protocols without compromising accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors influencing the uptake of 18F-fluoroestradiol in patients with estrogen receptor positive breast cancer. Peterson, LM., Kurland, BF., Link, JM., et al.[2021]

References

1. 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]

2. 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]

3. 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]

4. 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]

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

Summary: Appropriate Use Criteria for Estrogen Receptor-Targeted PET Imaging with 16α-18F-Fluoro-17β-Fluoroestradiol. [2023]

6. Greece pubmed.ncbi.nlm.nih.gov

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

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

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

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

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

9. 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]

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

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

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

Factors influencing the uptake of 18F-fluoroestradiol in patients with estrogen receptor positive breast cancer. [2021]