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

Recruiting in Palo Alto (17 mi)

Overseen by Neil Taunk, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Abramson Cancer Center at Penn Medicine

Must not be taking: Tamoxifen, Fulvestrant

Disqualifiers: Pregnancy, Imaging intolerance, others

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

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.

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.

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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.

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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.

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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.

I am 18 years old or older.

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

Trial 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

Participant Groups

[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.

Group I: Recurrent or metastatic uterine cancer Experimental Treatment 1 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

Research Locations Nearby Select from list below to view details:

Abramson Cancer Center at University of Pennsylvania Philadelphia, PA

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine Lead Sponsor

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] 18F-Fluoroestradiol [18F]FES has emerged as a valuable PET tracer to predict the response to hormone therapy in recurrent or metastatic breast cancer patients. A clinically acceptable product requires a rapid reliable synthesis and must be demonstrated to maintain chemical stability and receptor specific uptake during patient studies. [18F]FES then becomes a dependable tracer for the evaluation and management of breast cancer patients.

2. England pubmed.ncbi.nlm.nih.gov

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] Label="PURPOSE">We compared the clinical value of 16a-18F-fluoro-17b-estradiol (18F-FES) positron emission tomography (PET)/computed tomography (CT) and 18F-fluoro-2-deoxy-D-glucose (18F-FDG) PET/CT and investigated whether and how 18F-FES PET/CT affects the implemented management of newly diagnosed estrogen receptor positive breast cancer patients.

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

Non-18F-2-Fluoro-2-Deoxy-d-Glucose PET/Computed Tomography in Gynecologic Oncology: An Overview of Current Status and Future Potential. [2018] The current status and future potential targets of non-18F-2-fluoro-2-deoxy-d-glucose (FDG) PET/computed tomography (CT) in 3 major gynecologic malignancies are discussed. Estrogen receptor-based 16alpha-18F-fluoro-17beta-estradiol (18F-FES) PET/CT has been investigated in (a) Uterine malignancies (both endometrial and myometrial pathologies) and (b) ovarian carcinoma. For uterine tumors, FDG/FES standardized uptake value and/or uptake ratio showed a positive correlation with malignant transformation (ie, endometrial carcinoma and uterine sarcoma) and higher malignant grades, whereas higher 18F-FES uptake was documented in benign pathologies (ie, endometrial hyperplasia and leiomyoma). For epithelial ovarian carcinomas, 18F-FES PET/CT can predict the response to antiestrogen therapy in platinum-resistant cases.

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

PET Imaging of Estrogen Receptors for Gynecological Tumors. [2022] In the past few decades, PET with 18F-FDG has been used for the diagnosis of gynecological malignancies and is considered to be superior to conventional imaging methods in diagnostic accuracy for detecting metastatic lesions and local recurrence and in evaluating the treatment response. On the other hand, several gynecological tumors, such as endometrial cancer and leiomyoma, and breast cancer are estrogen-dependent, in which estrogen is essential for their development and progression. 18F-FES is an 18F-labeled compound of estradiol, the most bioactive type of estrogen, and 18F-FES PET has been well-established for diagnosis, staging, and posttherapeutic follow-up in patients with estrogen receptor-positive breast cancer. Compared with in vitro assessment of tumor biopsy material, PET imaging has the advantages of being able to measure in vivo tumor behavior, characterize the entire tumor burden, and capture the heterogeneity of the tumor phenotype. In this article, we review the phenotyping of estrogen-related gynecological tumors other than breast cancer using 18F-FES PET and demonstrate the additional value of 18F-FES PET to 18F-FDG PET in their diagnosis and prognostication. Moreover, promising PET tracers other than 18F-FES and 18F-FDG for the evaluation of estrogen-related gynecological tumors are introduced.

5. 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] PET with 16α-[18F]-fluoro-17β-estradiol ([18F]FES) allows assessment of whole body estrogen receptor (ER) expression. The aim of this study was to investigate [18F]-fluorodeoxyglucose ([18F]FDG) and [18F]FES PET/CT imaging for response prediction and monitoring of drug activity in patients with metastatic ER-positive breast cancer undergoing treatment with the selective estrogen receptor downregulator (SERD) rintodestrant.

6. 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] 18F-fluoroestradiol (18F-FES) is a Food and Drug Administration-approved radiopharmaceutical used for molecular imaging of the estrogen receptor (ER). When combined with PET, 18F-FES may improve the diagnosis of ER-positive breast cancer in the metastatic setting and provide insights into tumor heterogeneity. In this article, we review data on the use of 18F-FES imaging for treatment selection, staging, imaging lobular breast cancer, and the novel breast specific imaging tool, dedicated breast PET.

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

Factors influencing the uptake of 18F-fluoroestradiol in patients with estrogen receptor positive breast cancer. [2021] (18)F-Fluoroestradiol (FES) PET imaging provides a non-invasive method to measure estrogen receptor (ER) expression in tumors. Assessment of factors that could affect the quantitative level of FES uptake is important as part of the validation of FES PET for evaluating regional ER expression in breast cancer.

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

[18F]fluoroestradiol radiation dosimetry in human PET studies. [2016] [18F]16alpha-fluoroestradiol (FES) is a PET imaging agent useful for the study of estrogen receptors in breast cancer. We estimated the radiation dosimetry for this tracer using data obtained in patient studies.

9. Japan pubmed.ncbi.nlm.nih.gov

Distinctive FDG and FES accumulation pattern of two tamoxifen-treated patients with endometrial hyperplasia. [2016] 16alpha-[(18)F]Fluoro-17beta-estradiol (FES) is an estrogen receptor (ER) ligand used for the detection of ER-positive malignant tumors such as breast cancer. We recently reported the feasibility of combined FES-and 2-[(18)F]fluoro-2-deoxy-D-glucose (FDG)-positron emission tomography (PET) scans for the differential diagnosis of endometrial tumors. ER expression measured by FES-PET was preserved in endometrial hyperplasia, whereas ERs were assumed to be reduced in endometrial carcinoma with accelerated glucose metabolism measured by FDG-PET. We report two postmenopausal patients under suspicion of endometrial carcinoma on the basis of cytology and/or magnetic resonance imaging (MRI), who were on tamoxifen treatment since undergoing surgery for breast cancer. Pelvic MRI suggested endometrial carcinomas, whereas FDG-and FES-PET showed no abnormal tracer accumulation. A postoperative histopathologic examination revealed that the lesions were endometrial hyperplasias with no malignant findings. FES-PET enables us to evaluate the ERalpha expression of endometrium noninvasively, whereas the evaluation of ER expression using FES-PET requires careful attention regarding the influence of hormonal therapy because tamoxifen greatly affects FES accumulation of even endometrial hyperplasia, which should be an FES-avid lesion.

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] 16α-(18)F-fluoro-17β-estradiol ((18)F-FES) is an estrogen receptor (ER)-specific PET tracer with various potential interesting applications. The precise contribution of this technique in current clinical practice, however, has yet to be determined. Therefore, the aim of this study was to evaluate the value of (18)F-FES PET in breast cancer patients presenting with a clinical dilemma.