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Hybrid Molecular Imaging for Breast Cancer
Study Summary
This trial is testing a new method (using 18F-FES) to measure the extent of disease in participants with DCIS scheduled for diagnostic breast MRI, with the goal of improving preoperative staging.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- Your body is too big to fit inside the MRI/PET scanner.You cannot have an MRI or take certain contrast agents due to allergies or other health problems.You have taken a medication that blocks estrogen receptors within 6 weeks before the study.You have had an allergic reaction to similar chemicals or biological substances like 18F-FES in the past.You cannot have conscious sedation through an IV for imaging. If you need mild, oral anxiety medication for an MRI, you can participate if you have your own prescription, take the medication before the study, and have someone to drive you or have an alternative transportation plan.You are currently having a breast MRI to check the stage and extent of your disease.You have been diagnosed with a specific type of non-invasive breast cancer that measures at least 1.0 cm in size using imaging tests.You have liver failure, as determined by your doctor, which affects the way your liver filters 18F-FES.
- Group 1: Research Arm
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What is the (18F)FES regulatory status in the US?
"While (18F)FES does not have any efficacy data yet, it did receive a score of 2 because there is at least some safety data available from Phase 2 clinical trials."
How many participants are being asked to join this experiment?
"Yes, as indicated by the most recent update on clinicaltrials.gov, this study is still looking for participants. The trial was posted on January 3rd, 2019 and updated July 5th, 2022. So far, 12 patients have been enrolled at 1 site."
Are we still recruiting people for this research project?
"The study, which was posted on clinicaltrials.gov on 1/3/2019 is currently looking for patients. The listing was edited most recently on 7/5/2022"
Why was this clinical trial designed and what are its key goals?
"The primary objective of this 36-month study is to assess the ER immunohistochemistry score. Additionally, the trial will research secondary outcomes including Prognostic risk categories determined using Van Nuys Prognostic index and the MSKCC nomogram. There is also an intention to determine the optimal cut-point for 18F-FES SUVmax to distinguish low-risk DCIS and intermediate/high-risk DCIS. Furthermore, the team plans to evaluate sensitivity and specificity with two-sided 95% confidence intervals. The AUCs for the ROCs will be calculated using logistic regression and analyzed separately for each risk"
What have been (18F)FES's most successful applications thus far?
"(18F)FES is commonly used to treat advanced androgen dependent prostate cancer. (18F)FES can also alleviate other conditions such as amenorrhea, hypoestrogenism, and vasomotor symptoms caused by menopause."
Is (18F)FES a new investigational drug?
"58 clinical studies testing (18F)FES are ongoing, with 8 of them in Phase 3. Most trials for (18F)FES are based out of Nanjing, Jiangsu but there are 793 medical centres conducting research on the topic."
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