NCT03703492

Hybrid Molecular Imaging of ER in Breast Cancer Patients With DCIS

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Integrated whole-body magnetic resonance imaging (MRI)-positron emission tomography (PET) scanners have recently been introduced for clinical use. This technology combines the anatomic and perfusion data obtained with Dynamic Contrast Enhanced (DCE) MRI with functional imaging data obtained from PET. For breast imaging, the combination of MRI and PET has important potential to improve diagnostic accuracy and provide molecular characterization of breast cancer. The overall purpose of this research is to determine the technical feasibility of simultaneous breast DCE MRI with 18F-FES PET for measuring estrogen receptor (ER) in patients with ductal carcinoma in situ (DCIS) and identifying patients with low-risk of disease recurrence. The hypothesis is that quantitative 18F-FES uptake parameters from PET/MRI will correlate well with the ER immunohistochemistry score and with low-risk recurrence scores. Primary Objective 1) To compare quantitative 18F-FES uptake of biopsy-proven DCIS measured using PET/MRI with ER protein levels determined by immunohistochemistry. Secondary Objectives 1. To determine the optimal cut-point 18F-FES uptake value for distinguishing between ER+ and ER-negative DCIS 2. To determine the test-retest reproducibility of quantitative assessment of tumor 18F-FES uptake 3. To determine the optimal cut-point 18F-FES uptake value for distinguishing between low-risk DCIS and intermediate/high-risk DCIS 4. To estimate the association of quantitative 18F-FES uptake (continuous SUVmax) with research-based Oncotype DX DCIS scores (0-100) 5. To measure the upgrade rate to invasive cancer at surgical excision 6. To correlate tumor 18F-FES uptake with serum estradiol and sex hormone binding globulin levels. Exploratory Objective 1\) To correlate tumor cell density with 18F-FES uptake on PET/MRI

Conditions

• Breast Cancer
• Ductal Carcinoma in Situ - Category

Interventions

Type	Name	Description
DRUG	(18F)FES	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
DRUG	Gadobenate dimeglumine	Gadolinium-based intravenous contrast agent used for the MRI portion of this study

Timeline

• Start date: 2019-01-03
• Primary completion: 2024-01-02
• Completion: 2024-01-02
• First posted: 2018-10-12
• Last updated: 2025-02-12
• Results posted: 2025-02-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study