30 Participants Needed

[18F]FES PET/CT Imaging for Uterine Cancer

Eo
SL
Overseen ByShannon Long
Age: 18+
Sex: Female
Trial Phase: Phase 2
Sponsor: Abramson Cancer Center at Penn Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

If you are currently taking tamoxifen or fulvestrant, you will need to stop and wait for 8 weeks or 28 weeks, respectively, before the scan. For other medications, the protocol does not specify any requirements.

What data supports the effectiveness of the drug 18F-Fluoroestradiol for uterine cancer?

Research shows that 18F-FES PET/CT imaging can help in diagnosing and understanding the behavior of uterine tumors by measuring estrogen receptor activity, which is important since some uterine cancers are estrogen-dependent. This imaging technique has been effective in breast cancer for similar reasons, suggesting potential usefulness in uterine cancer as well.12345

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

18F-FES is a radiopharmaceutical approved by the FDA for imaging estrogen receptors, primarily used in breast cancer studies. It has been used in human studies to estimate radiation exposure, indicating it is generally considered safe for imaging purposes.36789

How does [18F]FES PET/CT imaging differ from other treatments for uterine cancer?

[18F]FES PET/CT imaging is unique because it uses a special tracer to visualize estrogen receptors in the body, helping to assess the presence and behavior of uterine tumors. This method is different from traditional imaging as it provides detailed information about the tumor's estrogen receptor status, which can be crucial for diagnosis and treatment planning.345910

What is the purpose of this trial?

Women with known or suspected recurrent or metastatic uterine cancer may be eligible for this study. Patients may participate in this study if they are at least 18 years of age, most participants will be receiving care at the clinical practices of the University of Pennsylvania.\[18F\]fluoroestradiol (FES) PET/CT imaging will be used to evaluate estrogen receptor (ER) activity in areas of disease known by standard of care imaging (e.g. CT, MRI, Bone Scan, FDG PET/CT, ultrasound) or clinical exam. For patients starting a new line of therapy, imaging will occur prior to starting new therapy. For patients who completed an initial scan and are starting new therapy, some patients may also undergo a second FES PET/CT scan at the time of suspected progression of disease to compare for changes in FES uptake measures (prior to initiation of next line therapy). The selection of therapy will be made by a treating physician and will not be affected by participation in this imaging study. Results of the FES PET/CT scan may be shared with the treating physician or subject by request but will not be used to make clinical decisions about treatment.

Research Team

NT

Neil Taunk, MD

Principal Investigator

Abramson CC

Eligibility Criteria

This trial is for women aged 18 or older with recurrent, metastatic, or untreated uterine cancer confirmed by biopsy or imaging. Participants must have at least one lesion outside the liver and cannot be pregnant. Those on tamoxifen or fulvestrant need a washout period before scanning. The study requires informed consent.

Inclusion Criteria

I have at least one cancer spot outside my liver, confirmed by scans.
I stopped taking tamoxifen or fulvestrant 8 or 28 weeks ago, respectively, before a FES PET/CT scan.
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
See 1 more

Exclusion Criteria

Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study
Females who report they are pregnant at screening will not be eligible for this study. A urine pregnancy test will be performed in women of child-bearing potential prior to FES injection
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

Initial Imaging

Participants undergo the first FES PET/CT scan to evaluate estrogen receptor activity

1 day
1 visit (in-person)

Optional Second Imaging

Participants may undergo a second FES PET/CT scan at the time of disease progression to compare changes in FES uptake

1 day
1 visit (in-person)

Follow-up

Participants are monitored for changes in FES uptake and progression-free survival

1 year

Treatment Details

Interventions

  • 18F-Fluoroestradiol
Trial Overview [18F]Fluoroestradiol (FES) PET/CT scans are being tested to assess estrogen receptor activity in uterine cancer lesions. This may include initial scans before therapy and follow-up scans at disease progression to observe changes in FES uptake.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Recurrent or metastatic uterine cancerExperimental Treatment1 Intervention
Women with known or suspected recurrent or metastatic uterine cancer may be eligible for this study. Patients may participate in this study if they are at least 18 years of age, most participants will be receiving care at the clinical practices of the University of Pennsylvania. \[18F\]fluoroestradiol (FES) PET/CT imaging will be used to evaluate estrogen receptor (ER) activity in areas of disease known by standard of care imaging (e.g. CT, MRI, Bone Scan, FDG PET/CT, ultrasound) or clinical exam. For patients starting a new line of therapy, imaging will occur prior to starting new therapy. For patients who completed an initial scan and are starting new therapy, some patients may also undergo a second FES PET/CT scan at the time of suspected progression of disease to compare for changes in FES uptake measures (prior to initiation of next line therapy).

Find a Clinic Near You

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials
425
Recruited
464,000+

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.
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 19 women with newly diagnosed estrogen receptor-positive breast cancer, 18F-FES PET/CT demonstrated a higher sensitivity (90.8%) for detecting lesions compared to 18F-FDG PET/CT (82.8%), indicating its superior diagnostic capability.
The use of 18F-FES PET/CT led to a change in treatment management for 26.3% of patients, highlighting its potential to significantly influence clinical decisions in the management of ER-positive breast cancer.
18F-FES PET/CT Influences the Staging and Management of Patients with Newly Diagnosed Estrogen Receptor-Positive Breast Cancer: A Retrospective Comparative Study with 18F-FDG PET/CT.Liu, C., Gong, C., Liu, S., et al.[2020]
In gynecologic cancers, 18F-FES PET/CT imaging can help differentiate between malignant and benign uterine tumors, as higher uptake is associated with more aggressive cancers like endometrial carcinoma and uterine sarcoma.
For patients with platinum-resistant epithelial ovarian carcinoma, 18F-FES PET/CT can predict how well they will respond to antiestrogen therapy, highlighting its potential as a valuable tool in treatment planning.
Non-18F-2-Fluoro-2-Deoxy-d-Glucose PET/Computed Tomography in Gynecologic Oncology: An Overview of Current Status and Future Potential.Kalshetty, A., Basu, S.[2018]

References

Clinical production, stability studies and PET imaging with 16-alpha-[18F]fluoroestradiol ([18F]FES) in ER positive breast cancer patients. [2016]
18F-FES PET/CT Influences the Staging and Management of Patients with Newly Diagnosed Estrogen Receptor-Positive Breast Cancer: A Retrospective Comparative Study with 18F-FDG PET/CT. [2020]
Non-18F-2-Fluoro-2-Deoxy-d-Glucose PET/Computed Tomography in Gynecologic Oncology: An Overview of Current Status and Future Potential. [2018]
PET Imaging of Estrogen Receptors for Gynecological Tumors. [2022]
[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]
Molecular Imaging for Estrogen Receptor-Positive Breast Cancer: Clinical Applications of Whole Body and Dedicated Breast Positron Emission Tomography. [2023]
Factors influencing the uptake of 18F-fluoroestradiol in patients with estrogen receptor positive breast cancer. [2021]
[18F]fluoroestradiol radiation dosimetry in human PET studies. [2016]
Distinctive FDG and FES accumulation pattern of two tamoxifen-treated patients with endometrial hyperplasia. [2016]
10.United Statespubmed.ncbi.nlm.nih.gov
PET imaging of estrogen receptors as a diagnostic tool for breast cancer patients presenting with a clinical dilemma. [2016]
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