search
Back to results

[18F]FES PET/.CT in Uterine Cancer

Primary Purpose

Uterine Cancer

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
18F-Fluoroestradiol
Sponsored by
Abramson Cancer Center at Penn Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Uterine Cancer focused on measuring estrogen receptor PET imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria 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. Exclusion Criteria 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

Sites / Locations

  • Abramson Cancer Center at University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Recurrent or metastatic uterine cancer

Arm Description

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
PFS
Correlate FES uptake with estimate of progression-free survival
Pathology
Correlate FES PET/CT uptake measures with standard and experimental pathology (e.g. estrogen receptor-alpha, estrogen receptor-beta)
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

Full Information

First Posted
April 18, 2023
Last Updated
September 14, 2023
Sponsor
Abramson Cancer Center at Penn Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT05916196
Brief Title
[18F]FES PET/.CT in Uterine Cancer
Official Title
[18F]FLUOROESTRADIOL (FES) PET/CT IMAGING OF THE ESTROGEN RECEPTOR IN PATIENTS WITH METASTATIC OR RECURRENT UTERINE CANCER
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
August 1, 2025 (Anticipated)
Study Completion Date
August 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. [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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cancer
Keywords
estrogen receptor PET imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Recurrent or metastatic uterine cancer
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
18F-Fluoroestradiol
Other Intervention Name(s)
18F-FES
Intervention Description
18F-FES PET/CT
Primary Outcome Measure Information:
Title
rate of FES positivity in ER+ uterine cancer
Description
Evaluate utility of FES PET/CT to detect estrogen receptor (ER+) uterine cancer lesions in patients with recurrent or metastatic uterine cancer
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Number of FES positive sites compared to standard of care imaging
Description
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
Time Frame
6 weeks
Title
PFS
Description
Correlate FES uptake with estimate of progression-free survival
Time Frame
5 years
Title
Pathology
Description
Correlate FES PET/CT uptake measures with standard and experimental pathology (e.g. estrogen receptor-alpha, estrogen receptor-beta)
Time Frame
6 weeks
Title
Change in FES at progression
Description
In patients who receive a second FES PET/CT scan, compare FES uptake in patients at initial scan and at progression
Time Frame
1 year

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Uterine cancer is only possible in women who were born female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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. Exclusion Criteria 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erin o Schubert
Phone
2155736569
Email
erin.schubert@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Shannon Long
Email
shannon.long@pennmedicine.upenn.edu
Facility Information:
Facility Name
Abramson Cancer Center at University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

[18F]FES PET/.CT in Uterine Cancer

We'll reach out to this number within 24 hrs