(18F)FES for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Breast Cancer+1 More(18F)FES - Drug
Eligibility
18+
Female
What conditions do you have?
Select

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.

Eligible Conditions
  • Breast Cancer
  • Ductal Carcinoma in Situ

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

3 Primary · 11 Secondary · Reporting Duration: 36 months

1 day
18F-FES uptake in DCIS
Serum Estradiol Levels
Serum Sex Hormone Binding Globulin Levels
12 months
Research-based Oncotype DX DCIS scores
2 months
Prognostic risk categories determined using Van Nuys Prognostic index, the MSKCC nomogram
Upgrade Rate to Invasive Cancer at Surgical Excision.
36 months
18F-FES uptake value for distinguishing between ER+ and ER-negative DCIS
Correlation of 18F-FES uptake in DCIS to ER immunohistochemistry score
Correlation of 18F-FES uptake with tumor cell density
Correlation of Tumor 18F-FES uptake with Serum Estradiol Levels
Correlation of Tumor 18F-FES uptake with Sex Hormone Binding Globulin Levels
ER immunohistochemistry score
Estimate the association of quantitative 18F-FES uptake with research-based Oncotype DX DCIS scores
Genomic Risk Scores
Optimal cut-point 18F-FES uptake value for distinguishing between low-risk DCIS and intermediate/high-risk DCIS
Neoplasms

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
[18F]Fluoroestradiol (FES) PET/CT
1
Tamoxifen
1
[18F]FLT-PET/CT

Trial Design

1 Treatment Group

Research Arm
1 of 1

Experimental Treatment

12 Total Participants · 1 Treatment Group

Primary Treatment: (18F)FES · No Placebo Group · Phase 2

Research ArmExperimental Group · 2 Interventions: (18F)FES, Gadobenate dimeglumine · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gadobenic acid
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 36 months

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,077 Previous Clinical Trials
41,139,616 Total Patients Enrolled
924 Trials studying Breast Cancer
1,536,219 Patients Enrolled for Breast Cancer
University of Wisconsin, MadisonLead Sponsor
1,069 Previous Clinical Trials
2,576,429 Total Patients Enrolled
32 Trials studying Breast Cancer
38,441 Patients Enrolled for Breast Cancer
Amy FowlerPrincipal InvestigatorUniversity of Wisconsin, Madison

Eligibility Criteria

Age 18+ · Female Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The diagnosis of biopsy-proven DCIS without invasion or microinvasion measuring at least 1.
References

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