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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new imaging method for individuals with estrogen-receptor positive breast cancer. The imaging combines BPET and DBT techniques to capture detailed breast images after injecting a special substance called FES (18F-Fluoroestradiol). The goal is to evaluate the effectiveness of this imaging, not to guide treatment plans. Ideal participants are those recently diagnosed with this type of breast cancer and have a breast lesion visible in standard imaging that is 1 cm or larger. As an Early Phase 1 trial, this research focuses on understanding how this new imaging method works in people, offering participants a chance to contribute to pioneering advancements in breast cancer diagnostics.

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 prior data suggests that this imaging technique is safe for breast cancer patients?

Previous studies have shown that 18F-Fluoroestradiol (FES) is safe for imaging estrogen receptors in breast cancer. The FDA has approved this substance for this purpose, confirming its safety for human use. Research indicates that FES is generally well-tolerated, with no serious side effects reported.

The imaging device in this trial combines two types of scans: Breast Positron Emission Tomography (BPET) and Digital Breast Tomosynthesis (DBT). Although this combination is new, each scan has been used safely in other contexts. Overall, existing evidence supports the safety of both FES and the imaging methods used in this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FES-PET/DBT imaging technique for breast cancer because it offers a new way to visualize the disease. Unlike standard imaging methods like mammography or MRI, this method uses a compound called 18F-FES, which can highlight estrogen receptor activity in breast cancer cells. This potentially provides a more precise picture of how the cancer is behaving, which can help tailor treatments more effectively. By combining FES-PET with digital breast tomosynthesis (DBT), this approach aims to improve the accuracy of breast cancer detection and characterization, offering a promising upgrade to current imaging technologies.

What evidence suggests that this imaging technique is effective for breast cancer?

This trial will evaluate the effectiveness of FES-BPET/DBT imaging for breast cancer. Research has shown that 18F-FES PET imaging effectively detects breast cancer with estrogen receptors. Studies indicate it enhances diagnostic understanding and aids in making informed treatment decisions, with approximately 79% accuracy in predicting patient response to hormone therapy. The BPET/DBT imaging system combines PET scans with digital breast tomosynthesis to produce detailed breast images, improving the detection and accurate identification of invasive breast cancer. Together, these imaging methods serve as powerful tools for evaluating ER-positive breast cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

Christine Edmonds, MD

Principal Investigator

Abramson Cancer Center at Penn Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

[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]

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]

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 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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12110083/

The Role of [18F]FES PET/CT in Breast Cancer Management Our findings consistently demonstrate that [18F]FES PET or PET/CT is highly effective in identifying ER-positive lesions, with sensitivity and ...

2. jnm.snmjournals.org jnm.snmjournals.org/content/65/11/1689

Impact of 18 F-FES PET/CT on Clinical Decisions in the ... F-FES PET/CT has been reported to improve clinicians' diagnostic understanding (10), influence therapeutic decisions (10,11), and resolve ...

3. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)04114-0/fulltext

36O 18F-fluoroestradiol (18F-FES) PET/CT guided first-line ... HR+/HER2- MBC patients with FES-guided initial treatment showed significantly better efficacy than those who had not been assessed by FES-PET/CT in real world.

4. ejnmmires.springeropen.com ejnmmires.springeropen.com/articles/10.1186/s13550-025-01205-x

[18F]F-FES PET for diagnosis, staging, and endocrine therapy ... For predicting response to endocrine therapy (12 studies), [18F]F-FES PET/CT showed a sensitivity of 0.79 (95% CI: 0.62–0.89) and an FPR of 0.58 ...

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0302486

Clinical and economic outcomes of adding [ 18 F]FES PET/CT ... The aim of this study was to estimate the budget impact and cost-effectiveness of adding [ 18 F]FES PET/CT to biopsy/IHC in the determination of ER-positive ...

6. cancer.gov cancer.gov/clinicaltrials/NCI-2023-09275

Evaluating the Uptake of [18F] Fluoroestradiol (FES) BPET ... This phase I trial studies a new scanner device that combines two types of imaging called breast positron emission tomography (BPET) and digital breast ...

7. withpower.com withpower.com/trial/early-phase-1-breast-neoplasms-2023-07730

FES-PET/DBT Imaging for Breast Cancer 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 ...

8. ctv.veeva.com ctv.veeva.com/study/fes-bpet-dbt-in-newly-diagnosed-breast-cancer

FES BPET-DBT in Newly Diagnosed Breast Cancer Study subjects will undergo imaging of the breast with a novel device combining dedicated Breast Positron Emission Tomography (BPET) and Digital ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10411708/

18F-fluoroestradiol positron emission tomography in ... Current evidence suggests that 18F-FES PET for the detection of ER-positive lesions in breast cancer patients is sensible, with a pooled sensitivity of 82%, ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT02149173?term=FLUOROESTRADIOL%20F-18&viewType=Table&rank=2

NCT02149173 | F-18 FES PET/CT in Measuring Hormone ... I. Document the safety profile of FES PET in patients with breast cancer. II. Examine associations between FES PET results and serial measurements of hormone or ...