Serial FES PET/CT to Measure Hormone Expression in Patients Undergoing Endocrine Targeted Therapy (NCT04692103) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Serial FES PET/CT to Measure Hormone Expression in Patients Undergoing Endocrine Targeted Therapy
United States2 participantsStarted 2021-07-10
Plain-language summary
This clinical trial studies use of F-18 16 alpha-fluoroestradiol (\[F-18\] FES) positron emission tomography (PET)/computed tomography (CT) in measuring tumor hormone receptor expression in patients undergoing endocrine-targeted therapy for newly diagnosed breast cancer or breast cancer that has come back or spread to other places in the body. Comparing results of diagnostic procedures done before, during, and after hormone therapy may help measure a patient's response to treatment.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult, non-pregnant patients with biopsy-proven or clinically obvious primary, recurrent or metastatic breast cancer
* Breast cancer from ER+ primary that is seen on other imaging tests. Tumor ER expression must have been confirmed by immunohistocytochemistry of primary tumor or recurrent disease.
* At least one site of disease 1.5 cm or greater is needed to meet the spatial resolution limits of PET imaging.
* Patients must have been off tamoxifen or other estrogen receptor blocking agents for at least 6 weeks and off chemotherapy for 3 weeks for the initial baseline FES.
* Patients must be selected for an endocrine targeted therapy regimen for treatment of their breast cancer by the referring oncologist. Selected treatments may be part of experimental treatment protocols for which the patient would be separately consented.
* Patients must be willing to undergo serial imaging procedures.
* Patients must agree to allow access to clinical records regarding response to treatment and long term follow up.
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* An inability to lie still for the tests
* Individuals weighing more than 300 lb. (this is the weight limit of the scanner table)
* Pregnant or lactating. Women of childbearing potential with either a positive or no pregnancy test at baseline are excluded.
* Any other life-threatening illness (e.g. serious, uncontrolled concurrent infection or cli…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in F-18 16 Alpha-fluoroestradiol (FES) Standardized Uptake Value (SUV) - Avg SULmax
Timeframe: From time of first F-18 FES-PET/CT scan to time of second F-18 FES-PET/CT scan (approximately 1-12 weeks)
2
F-18 16 Alpha-fluoroestradiol (FES) Uptake
Timeframe: From time of first F-18 FES-PET/CT scan to time of second F-18 FES-PET/CT scan (approximately 1-12 weeks)
3
Proportion of Patients With a Threshold of Percentage Change, or That Surpass a Targeted Follow-up F-18 16 Alpha-fluoroestradiol (FES) Standardized Uptake Value (SUV)
Timeframe: From time of first F-18 FES-PET/CT scan to time of second F-18 FES-PET/CT scan (approximately 1-12 weeks)