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Hybrid Molecular Imaging for Breast Cancer

Phase 2
Waitlist Available
Led By Amy Fowler
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Undergoing diagnostic breast MRI ordered by the referring clinician for staging and extent of disease
Diagnosis of biopsy-proven DCIS without invasion or microinvasion measuring at least 1.0 cm in diameter by any imaging modality
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

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.

Who is the study for?
This trial is for individuals with a confirmed diagnosis of DCIS (a type of breast cancer) that's at least 1.0 cm in size, and who are scheduled for a preoperative breast MRI. It's not open to those who've had prior treatments for the current cancer, are pregnant or breastfeeding, have taken ER-blocking meds recently, exceed the MRI scanner size limit, or have allergies to similar compounds as 18F-FES.Check my eligibility
What is being tested?
The study tests how well DCIS tumors show up on PET/MRI scans using two agents: (18F)FES and Gadobenate dimeglumine. Participants will undergo these imaging procedures to measure tumor uptake values which could help in assessing the extent of disease before surgery.See study design
What are the potential side effects?
Potential side effects may include reactions related to the contrast agent used during MRI such as nausea or itching. There might also be risks associated with radiation exposure from PET imaging and allergic reactions specific to components of (18F)FES.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are currently having a breast MRI to check the stage and extent of your disease.
Select...
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
18F-FES uptake in DCIS
Secondary outcome measures
Prognostic risk categories determined using Van Nuys Prognostic index, the MSKCC nomogram
Research-based Oncotype DX DCIS scores
Serum Estradiol Levels
+2 more
Other outcome measures
Correlation of 18F-FES uptake with tumor cell density
Genomic Risk Scores

Trial Design

1Treatment groups
Experimental Treatment
Group I: Research ArmExperimental Treatment2 Interventions
Directed breast PET/MRI with 18F-FES; 18F-FES uptake of the known malignancy to be measured on the PET/MRI examination
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
(18F)FES
2019
Completed Phase 2
~20
Gadobenate dimeglumine
2019
Completed Phase 2
~360

Find a Location

Who is running the clinical trial?

National Center for Advancing Translational Sciences (NCATS)NIH
315 Previous Clinical Trials
387,819 Total Patients Enrolled
3 Trials studying Breast Cancer
1,853 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,607 Previous Clinical Trials
40,913,971 Total Patients Enrolled
938 Trials studying Breast Cancer
1,543,320 Patients Enrolled for Breast Cancer
University of Wisconsin, MadisonLead Sponsor
1,176 Previous Clinical Trials
3,011,988 Total Patients Enrolled
35 Trials studying Breast Cancer
38,506 Patients Enrolled for Breast Cancer

Media Library

(18F)FES Clinical Trial Eligibility Overview. Trial Name: NCT03703492 — Phase 2
Breast Cancer Research Study Groups: Research Arm
Breast Cancer Clinical Trial 2023: (18F)FES Highlights & Side Effects. Trial Name: NCT03703492 — Phase 2
(18F)FES 2023 Treatment Timeline for Medical Study. Trial Name: NCT03703492 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI

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"

Answered by AI

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."

Answered by AI

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."

Answered by AI
~2 spots leftby Mar 2025