Uterine CancerPhase 2NCT05916196
[18F]FES PET/.CT in Uterine Cancer
A Phase 2 study testing 18F-Fluoroestradiol in people with Uterine Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Cancer
- What is being tested?
- 18F-Fluoroestradiol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2024to 1 Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will be ≥ 18 years of age
- Recurrent or metastatic or intact non-operated uterine cancer not treated with surgery that is biopsy-proven or demonstrated on other standard of care imaging (e.g. CT, FDG PET/CT, MRI, bone scan, x-ray, ultrasound)
- At least one lesion outside the liver detected by standard of care imaging (e.g.CT, FDG PET/CT, MRI, bone scan, x-ray, ultrasound)
- 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.
- Subjects that are currently on or have recently discontinued tamoxifen or fulvestrant would require an 8-week or 28-week, respectively, washout period prior to FES PET/CT scan.
Who cannot join
- 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
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Shannon Long contact
United States1 site, 1 recruiting
- Recruiting
Abramson Cancer Center at University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: [18F]FLUOROESTRADIOL (FES) PET/CT IMAGING OF THE ESTROGEN RECEPTOR IN PATIENTS WITH METASTATIC OR RECURRENT UTERINE CANCER
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.
Read the detailed description
This is a phase II study using the novel radiotracer [18F]fluoroestradiol (FES). Patients with metastatic, recurrent, or intact non-operated uterine cancer not treated with surgery. Patients may participate in this study if they are at least 18 years of age. Volunteers that meet the eligibility criteria will be considered for study participation regardless of race or ethnic background. We anticipate enrolling up to 30 evaluable subjects who meet eligibility requirements for this study, due to the nature of the disease population all subjects will be women. Subjects will be considered evaluable if they complete at least one FES PET/CT scan. Patients who come to the University of Pennsylvania for diagnosis and/or treatment of this gynecological cancer may be approached by study personnel for recruitment into this study. Patients will be approached initially in person, by phone or email about study participation. After discussion of the study procedures, risks and benefits, if the subject agrees to participate in the study, the FES PET/CT will be ordered by a physician and scheduled. Subjects may cancel the scan appointment at any time prior to the injection of FES with no negative impact to them or their medical care at University of Pennsylvania. A written informed consent will be reviewed with the subject and signed prior to any study procedures being performed. The selection of therapy will be made by a treating physician and will not be affected by participation in this imaging study.
Accrual will likely occur over approximately 2 years. Subjects who are enrolled but are unable to complete the entirety of their FES imaging procedure will be considered non-evaluable. If this occurs, we will plan to replace this subject in the enrollment, due to this we anticipate that we may enroll up to 40 subjects in order to meet our target enrollment of 30 evaluable subjects.
Participants will undergo up to two FES PET/CT scans. The first scan is the initial study scan and the only required of the study. A second optional FES PET/CT scan may be done at the time of progression after initiation of therapy, prior to initiation of next line therapy, to collect data on the changes in FES uptake with therapy and therapy utilized.
Positron emission tomography (PET) imaging will be used to evaluate estrogen receptor activity in sites of metastatic uterine cancer using the investigational radiotracer [18F]FES. Imaging will be performed using a whole-body PET/CT scanner. The protocol will be performed under the regulatory approval of the IRB and FDA IND. Subjects will undergo a skull base to mid-thigh PET/CT scan starting at approximately 60 minutes after [18F]FES injection. Images will be reconstructed using standard reconstruction techniques.
If a patient will be undergoing a clinical biopsy or surgery, they may be asked to consent for collection of tissue for the purposes of this research study. If the investigator deems that there is a site accessible for research biopsy, the subject may be consented for an optional research only biopsy at baseline and after starting treatment; however, consent for research tissue collection is not required for entry into the study. Results of standard uterine cancer pathology immunohistochemistry (IHC) which includes estrogen receptor (ER), will be collected from archival tissue if available and performed on any new biopsy.
A research blood sample may be collected at the time of the FES PET/CT scan that will be evaluated for the presence of circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA). Identified CTCs will be tested for estrogen receptor positivity. Serum estradiol and other related levels including sex hormone-binding globulin (SHBG) will be analyzed. FES uptake measures will be compared to the number of ER+ CTCs and the ratio of ER + to ER- CTCs present. This blood draw will be optional and may be omitted at the choice of the investigator or the subject
- Conditions
- Uterine Cancer
- Being tested
- 18F-Fluoroestradiol
- Keywords
- estrogen receptor PET imaging
- Medical subject headings
- Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FluoroestradiolDrug
Also called 18F-FES
18F-FES PET/CT
| Study group | Role | What they receive |
|---|---|---|
| Recurrent or metastatic uterine cancer | Experimental | 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). Receives: Drug: 18F-Fluoroestradiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of FES positivity in ER+ uterine cancer
Evaluate utility of FES PET/CT to detect estrogen receptor (ER+) uterine cancer lesions in patients with recurrent or metastatic uterine cancer
Measured: 1 year
Secondary outcomes (4)
Number of FES positive sites compared to standard of care imaging
Evaluate utility of FES PET/CT compared to standard axial cross-sectional imaging and/or FDG PET/CT when available to establish tumor heterogeneity and staging
Measured: 6 weeks
PFS
Correlate FES uptake with estimate of progression-free survival
Measured: 5 years
Pathology
Correlate FES PET/CT uptake measures with standard and experimental pathology (e.g. estrogen receptor-alpha, estrogen receptor-beta)
Measured: 6 weeks
Change in FES at progression
In patients who receive a second FES PET/CT scan, compare FES uptake in patients at initial scan and at progression
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start5 Apr 2024
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neil Taunk, MD, Principal investigator, Abramson CC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05916196
- Sponsor's protocol ID
- 852782
- Other IDs
- UPCC 30822
- Status last verified
- Jun 2026
- First submitted
- 18 Apr 2023
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [18F]FLUOROESTRADIOL (FES) PET/CT IMAGING OF THE ESTROGEN RECEPTOR IN PATIENTS WITH METASTATIC OR RECURRENT UTERINE CANCER
- ClinicalTrials.gov ID
- NCT05916196
- Acronym / sponsor ID
- 852782
- Conditions
- Uterine Cancer
- Keywords
- estrogen receptor PET imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 5 Apr 2024 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a phase II study using the novel radiotracer [18F]fluoroestradiol (FES). Patients with metastatic, recurrent, or intact non-operated uterine cancer not treated with surgery. Patients may participate in this study if they are at least 18 years of age. Volunteers that meet the eligibility criteria will be considered for study participation regardless of race or ethnic background. We anticipate enrolling up to 30 evaluable subjects who meet eligibility requirements for this study, due to the nature of the disease population all subjects will be women. Subjects will be considered evaluable if they complete at least one FES PET/CT scan. Patients who come to the University of Pennsylvania for diagnosis and/or treatment of this gynecological cancer may be approached by study personnel for recruitment into this study. Patients will be approached initially in person, by phone or email about study participation. After discussion of the study procedures, risks and benefits, if the subject agrees to participate in the study, the FES PET/CT will be ordered by a physician and scheduled. Subjects may cancel the scan appointment at any time prior to the injection of FES with no negative impact to them or their medical care at University of Pennsylvania. A written informed consent will be reviewed with the subject and signed prior to any study procedures being performed. The selection of therapy will be made by a treating physician and will not be affected by participation in this imaging study.
Accrual will likely occur over approximately 2 years. Subjects who are enrolled but are unable to complete the entirety of their FES imaging procedure will be considered non-evaluable. If this occurs, we will plan to replace this subject in the enrollment, due to this we anticipate that we may enroll up to 40 subjects in order to meet our target enrollment of 30 evaluable subjects.
Participants will undergo up to two FES PET/CT scans. The first scan is the initial study scan and the only required of the study. A second optional FES PET/CT scan may be done at the time of progression after initiation of therapy, prior to initiation of next line therapy, to collect data on the changes in FES uptake with therapy and therapy utilized.
Positron emission tomography (PET) imaging will be used to evaluate estrogen receptor activity in sites of metastatic uterine cancer using the investigational radiotracer [18F]FES. Imaging will be performed using a whole-body PET/CT scanner. The protocol will be performed under the regulatory approval of the IRB and FDA IND. Subjects will undergo a skull base to mid-thigh PET/CT scan starting at approximately 60 minutes after [18F]FES injection. Images will be reconstructed using standard reconstruction techniques.
If a patient will be undergoing a clinical biopsy or surgery, they may be asked to consent for collection of tissue for the purposes of this research study. If the investigator deems that there is a site accessible for research biopsy, the subject may be consented for an optional research only biopsy at baseline and after starting treatment; however, consent for research tissue collection is not required for entry into the study. Results of standard uterine cancer pathology immunohistochemistry (IHC) which includes estrogen receptor (ER), will be collected from archival tissue if available and performed on any new biopsy.
A research blood sample may be collected at the time of the FES PET/CT scan that will be evaluated for the presence of circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA). Identified CTCs will be tested for estrogen receptor positivity. Serum estradiol and other related levels including sex hormone-binding globulin (SHBG) will be analyzed. FES uptake measures will be compared to the number of ER+ CTCs and the ratio of ER + to ER- CTCs present. This blood draw will be optional and may be omitted at the choice of the investigator or the subject
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recurrent or metastatic uterine cancer | Experimental | Drug: 18F-FluoroestradiolWomen 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants will be ≥ 18 years of age
- Recurrent or metastatic or intact non-operated uterine cancer not treated with surgery that is biopsy-proven or demonstrated on other standard of care imaging (e.g. CT, FDG PET/CT, MRI, bone scan, x-ray, ultrasound)
- At least one lesion outside the liver detected by standard of care imaging (e.g.CT, FDG PET/CT, MRI, bone scan, x-ray, ultrasound)
- 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.
- Subjects that are currently on or have recently discontinued tamoxifen or fulvestrant would require an 8-week or 28-week, respectively, washout period prior to FES PET/CT scan.
Key exclusion criteria (3 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-FluoroestradiolAlso: 18F-FES18F-FES PET/CT | Drug | Recurrent or metastatic uterine cancer |
Primary outcome
rate of FES positivity in ER+ uterine cancer
Time frame: 1 year
Evaluate utility of FES PET/CT to detect estrogen receptor (ER+) uterine cancer lesions in patients with recurrent or metastatic uterine cancer
4 secondary outcomes
Number of FES positive sites compared to standard of care imaging
Time frame: 6 weeks
PFS
Time frame: 5 years
Pathology
Time frame: 6 weeks
Change in FES at progression
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shannon Long contact
Neil Taunk, MD principal investigator
Abramson CC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 18F-Fluoroestradiol in people with Uterine Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin o Schubert (2155736569, erin.schubert@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of FES positivity in ER+ uterine cancer (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.