Your session is about to expire
← Back to Search
Hormone Receptor Imaging for Breast Cancer
Phase 2
Waitlist Available
Led By Hannah Linden
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Adult, non-pregnant patients with biopsy-proven or clinically obvious primary, recurrent or metastatic breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of therapy up to 20 years
Awards & highlights
Study Summary
This trial looks at using F-18 to measure hormone receptors in breast cancer patients before, during, and after hormone therapy. This may help show how well a patient responds to treatment.
Who is the study for?
This trial is for adults with breast cancer that has been confirmed to express hormone receptors and who are about to undergo endocrine therapy. They must not have taken certain medications recently, be able to lie still for scans, and consent to treatment records access. Pregnant individuals or those with uncontrolled diabetes, recent chemotherapy, or weighing over 300 lb cannot participate.Check my eligibility
What is being tested?
[F-18] FES PET/CT scans are being tested to see how well they measure the effect of hormone-targeted therapies on breast cancer by comparing images before, during, and after treatment. The goal is to better understand a patient's response to these therapies.See study design
What are the potential side effects?
While the description does not specify side effects from the interventions (imaging procedures), typical risks may include exposure to radiation from PET/CT scans which can increase cancer risk over time. There might also be discomfort or allergic reactions related to contrast agents used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is ER+ and confirmed by tests on the primary or recurrent tumor.
Select...
I am an adult with diagnosed breast cancer, not currently pregnant.
Select...
I stopped taking tamoxifen or similar drugs 6 weeks ago and chemotherapy 3 weeks ago.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from start of therapy up to 20 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of therapy up to 20 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in F-18 16 Alpha-fluoroestradiol (FES) Standardized Uptake Value (SUV) - Avg SULmax
F-18 16 Alpha-fluoroestradiol (FES) Uptake
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)
Secondary outcome measures
Time to Disease Progression
Trial Design
1Treatment groups
Experimental Treatment
Group I: Diagnostic (F-18 FES PET/CT)Experimental Treatment5 Interventions
Patients undergo F-18 FES PET/CT scan at baseline. Patients also undergo F-18 FES PET/CT and FDG PET/CT between 1-12 weeks after starting therapy, and then 1-12 weeks after the second FES PET/CT scan. Repeat FDG PET may be omitted in patients on selective estrogen receptor degrader.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positron Emission Tomography
2008
Completed Phase 2
~2240
Fludeoxyglucose F-18
2018
Completed Phase 2
~550
Computed Tomography
2017
Completed Phase 2
~2720
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,738 Previous Clinical Trials
1,844,349 Total Patients Enrolled
20 Trials studying Breast Cancer
3,253 Patients Enrolled for Breast Cancer
Hannah LindenPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
10 Previous Clinical Trials
425 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant, breastfeeding, or able to become pregnant without a negative pregnancy test.I cannot stay still for tests.My breast cancer is ER+ and confirmed by tests on the primary or recurrent tumor.I do not have any serious illnesses besides my cancer.I am an adult with diagnosed breast cancer, not currently pregnant.I stopped taking tamoxifen or similar drugs 6 weeks ago and chemotherapy 3 weeks ago.My blood sugar levels are not controlled and often exceed 200 mg/dL.I haven't taken ER blockers or chemotherapy within the last 6 and 3 weeks, respectively.You weigh more than 300 pounds, which is the maximum weight the scanner table can support.I need anesthesia for PET scans.You need to have at least one tumor site that is 1.5 cm or bigger for the PET scan to work properly.My oncologist has chosen hormone therapy for my breast cancer treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Diagnostic (F-18 FES PET/CT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the FDA recognize Positron Emission Tomography as a viable diagnostic tool?
"As this is a Phase 2 trial, which means there are some safety data available but not efficacy evidence, our team at Power have rated the security of Positron Emission Tomography as a score of 2 on their scale."
Answered by AI
Is there availability for participation within this clinical investigation?
"Clinicaltrials.gov has posted that this study is actively searching for participants, with the initial posting taking place on July 10th 2021 and its most recent edit conducted on April 21st 2022."
Answered by AI
To what extent has research on Positron Emission Tomography been explored?
"Currently, there are 24 active trials researching PET scans with 1 of them in the final phase. Most sites for these studies can be found in Wuhan, Hubei; however, a total of 50 clinical centres are running related experiments."
Answered by AI
How many individuals can partake in this experiment simultaneously?
"Affirmative. Clinicaltrials.gov has the latest information regarding this medical trial which was first established on July 10th 2021 and recently modified on April 21st 2022. 20 individuals are expected to be recruited from one site for research purposes."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger