Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2026-02-17 @ 11:36 PM
Study NCT ID:
NCT03703492
Status:
COMPLETED
Last Update Posted:
2025-02-12
First Post:
2018-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Hybrid Molecular Imaging of ER in Breast Cancer Patients With DCIS
Sponsor:
University of Wisconsin, Madison
Organization:
Study Overview
Official Title:
Positron Emission Tomography/Magnetic Resonance Imaging of Estrogen Receptor Expression n Non-Invasive Breast Cancer
Status:
COMPLETED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| KL2TR000428 | NIH | None | https://reporter.nih.gov/quic… | View |
| NCI-2018-02281 | REGISTRY | NCI Trial ID | View | |
| 2018-0814 | OTHER | Institutional Review Board | View | |
| A539300 | OTHER | UW Madison | View | |
| SMPH/RADIOLOGY/RADIOLOGY | OTHER | UW Madison | View | |
| P30CA014520 | NIH | None | https://reporter.nih.gov/quic… | View |
| Protocol Version 5/11/2022 | OTHER | UW Madison | View |