FES-PET/DBT Imaging for Breast Cancer

Overseen By Hannah Straughn

Age: 18+

Sex: Female

Trial Phase: Phase < 1

Sponsor: Abramson Cancer Center at Penn Medicine

Must not be taking: Tamoxifen, Raloxifene

Disqualifiers: Pregnancy, Breastfeeding, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking tamoxifen or raloxifene if you are currently on them.

What data supports the effectiveness of the treatment 18F-FES, 18F-Fluoroestradiol, FES, BPET/DBT Imaging, BPET/DBT Imaging, Dedicated Breast Positron Emission Tomography/Digital Breast Tomosynthesis Imaging for breast cancer?

Research shows that 18F-FES is effective in predicting the response to hormone therapy in breast cancer patients, especially those with estrogen receptor-positive (ER+) cancer. It helps in assessing the whole body estrogen receptor expression and can improve diagnosis and treatment selection for metastatic breast cancer. ^{1 2 3 4 5}

Is FES-PET/DBT Imaging safe for humans?

18F-Fluoroestradiol (FES) is an FDA-approved radiopharmaceutical used for imaging estrogen receptors in breast cancer, and it has been shown to be safe for use in humans. It is used to help diagnose and manage breast cancer, and while it shows uptake in various tissues, it is generally considered safe when used as directed. ^{3 6 7 8 9}

How is FES-PET/DBT imaging different from other breast cancer treatments?

FES-PET/DBT imaging is unique because it uses a special tracer, 18F-fluoroestradiol (18F-FES), to visualize estrogen receptors in breast cancer, helping to better diagnose and manage ER-positive breast cancer by assessing tumor characteristics and predicting response to hormone therapy. ^{1 2 3 4 10}

What is the purpose of this trial?

Patients with newly diagnosed primary estrogen-receptor (ER) positive breast cancer, with at least one breast lesion that is 1.0 cm in diameter or greater, may be eligible for this study. Patients may participate in this study if they are at least 18 years of age. Up to 20 evaluable subjects will participate in a single imaging cohort. Study subjects will undergo imaging of the breast with a novel device combining dedicated Breast Positron Emission Tomography (BPET) and Digital Breast Tomosynthesis (DBT) following intravenous injection of \[18F\]-Fluoroestradiol (FES). This is an observational study; FES-BPET/DBT will not be used to direct treatment decisions. While patients and referring physicians will not be blinded to the FES-BPET/DBT results, treatment decisions are made by the treating physicians based upon standard clinical imaging.

Research Team

Christine Edmonds, MD

Principal Investigator

Abramson Cancer Center at Penn Medicine

Eligibility Criteria

This trial is for adults over 18 with newly diagnosed estrogen-receptor positive breast cancer, featuring at least one lesion that's 1.0 cm or larger. It's not suitable for pregnant or breastfeeding women, those unable to undergo imaging procedures, taking tamoxifen/raloxifene, or with conditions compromising safety/participation.

Inclusion Criteria

Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.

My breast cancer is estrogen receptor positive.

I have a tumor larger than 1 cm visible on an imaging test.

Exclusion Criteria

I am currently taking tamoxifen or raloxifene.

Females who are pregnant or breast feeding will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential prior to PET imaging.

Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Session

Participants undergo FES-BPET/DBT imaging session following intravenous injection of [18F]-Fluoroestradiol (FES)

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

8 weeks

Treatment Details

Interventions

• 18F-FES
• BPET/DBT Imaging

Trial Overview The study tests a new imaging technique combining Breast Positron Emission Tomography (BPET) and Digital Breast Tomosynthesis (DBT) after an [18F]-Fluoroestradiol (FES) injection in patients. This observational study won't influence treatment decisions; up to 20 subjects will be imaged once.

Participant Groups

Group I: FES BPET-DBT Experimental Treatment 2 Interventions

FES-BPET/DBT imaging session

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

Abramson Cancer Center of the University of Pennsylvania

Lead Sponsor

Trials

360

Recruited

108,000+

Findings from Research

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-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]

F-FES PET/CT is an effective noninvasive imaging technique for assessing estrogen receptor (ER) expression in breast cancer, showing strong correlation with pathological features and high sensitivity (88.2%) and specificity (87.5%) for distinguishing ER-positive from ER-negative lesions.

The study found significant intratumoral heterogeneity in ER expression, particularly in recurrent or metastatic cases, suggesting that F-FES PET/CT can provide valuable insights for personalized treatment strategies in breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Assessment of Estrogen Receptor Status and Its Intratumoral Heterogeneity in Patients With Breast Cancer by Using 18F-Fluoroestradiol PET/CT. Yang, Z., Sun, Y., Xu, X., et al.[2018]

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]

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 16&#945;-18F-Fluoro-17&#946;-Fluoroestradiol. Ulaner, GA., Mankoff, DA., Clark, AS., et al.[2023]

[18F]fluoroestradiol (FES) PET is an FDA-approved imaging tool that can predict how well patients with cancer will respond to endocrine therapy, similar to traditional immunohistochemistry (IHC) methods.

Recent research indicates that measuring tumor heterogeneity with FES can help forecast clinical benefits and track the effectiveness of estrogen receptor blockade during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Molecular Imaging Find a Path to Navigate Evolving Breast Cancer Treatments? Linden, HM., Mankoff, DA.[2023]

18F-Fluoroestradiol (FES) is a promising radiotracer for assessing estrogen receptor status in ER positive breast cancer, but it can show diffuse uptake in the lungs due to factors like inflammation or interstitial disease, as seen in two case studies.

In the presented cases, one patient's lung uptake was linked to acute lung injury, while the other had a history of radiation therapy and emphysema, indicating that understanding the context of FES uptake is crucial for accurate interpretation in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diffuse bilateral 18F-Fluoroestradiol pulmonary uptake in patients with metastatic estrogen receptor positive breast cancer: A case report. Phillips, EF., Karak, PK.[2023]

The imaging agent (18)F-16alpha-17beta-fluoroestradiol (FES) shows promise for accurately identifying estrogen receptor (ER) expression in breast cancer, which is crucial for determining the effectiveness of endocrine therapies like tamoxifen.

Preliminary studies suggest that FES-PET could serve as a reliable predictive assay for breast cancer treatment, indicating its potential clinical utility and the need for further validation in future clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-Fluoroestradiol. Sundararajan, L., Linden, HM., Link, JM., et al.[2021]

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. 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]

2. 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]

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

The Assessment of Estrogen Receptor Status and Its Intratumoral Heterogeneity in Patients With Breast Cancer by Using 18F-Fluoroestradiol PET/CT. [2018]

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

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

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

Summary: Appropriate Use Criteria for Estrogen Receptor-Targeted PET Imaging with 16&#945;-18F-Fluoro-17&#946;-Fluoroestradiol. [2023]

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

Can Molecular Imaging Find a Path to Navigate Evolving Breast Cancer Treatments? [2023]

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

Diffuse bilateral 18F-Fluoroestradiol pulmonary uptake in patients with metastatic estrogen receptor positive breast cancer: A case report. [2023]

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

18F-Fluoroestradiol. [2021]

10. 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]