CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
(18F)FES +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03703492
NCT03703492Phase 2Completed

Positron Emission Tomography/Magnetic Resonance Imaging of Estrogen Receptor Expression n Non-Invasive Breast Cancer

University of Wisconsin, Madison·interventional·Posted Oct 12, 2018·Updated Feb 12, 2025

In Brief

A Phase 2 clinical trial evaluating (18F)FES and Gadobenate dimeglumine for Breast Cancer and Ductal Carcinoma in Situ - Category. Completed, enrolled 12 participants across 1 site.

Detailed Summary

This prospective, one-arm study which will enroll participants with biopsy-proven DCIS scheduled for diagnostic breast MRI for preoperative staging/extent of disease evaluation as part of standard of care. Eligible participants will be consented for participation in the research study which includes a directed breast PET/MRI with 18F-FES. 18F-FES uptake of the known malignancy will be measured on the PET/MRI examination using standardized uptake values (SUV) and tumor-to-normal tissue ratios.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedOct 12, 2018
Enrollment StartJan 3, 2019
Primary CompletionJan 2, 2024
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 7.7 years ago

Interventions

(18F)FESdrug

18F-FES is an investigational new drug which will be used for this study. For complete information, please refer to the Investigator's Brochure: "\[18F\]Fluoroestradiol: An investigational positron emission tomography (PET) radiopharmaceutical for injection, intended for use as an in vivo diagnostic for imaging estrogen receptors in tumors

Gadobenate dimegluminedrug

Gadolinium-based intravenous contrast agent used for the MRI portion of this study