Actively Recruiting
Screening Contralateral Breast Cancers in Patients With Newly Diagnosed Breast Cancer
Led by Seoul National University Hospital · Updated on 2024-05-29
1098
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In women with newly diagnosed breast cancer, synchronous contralateral breast cancer is reported in 1% to 3%. During the initial diagnosis of breast cancer, it is important to detect the contralateral cancer to avoid second round of cancer therapy. Because breast MRI is a highly sensitive modality, it is used for screening of occult contralateral disease in women newly diagnosed with breast cancer and detects contralateral cancers not seen on clinical or conventional imaging (mammography and ultrasonography) in 4.1% of women. However, the use of breast MRI for screening contralateral breast cancer, is limited not only by high costs and long examination time but also by high false-positive findings resulting in more benign biopsies and extensive surgeries. In addition, the use of intravenous gadolinium-based contrast agent is contraindicated in pregnancy and in women with renal impairment or contrast material allergy contrast. Thus, there is a need to develop a more safe and cost-effective supplemental imaging modality for screening breast cancer. Diffusion-weighted (DW) MRI is a fast, functional modality that measures the movement of water molecules to create tissue contrast without the need for contrast injection. Breast malignancies exhibit hindered diffusion and appear hyperintense on DW MRI with low apparent diffusion coefficient (ADC) compared to normal surrounding tissue. A number of studies have shown that the use of DW MRI can significantly reduce the false positives and unnecessary benign biopsy of breast MRI. Several studies have explored how to use DW MRI as a stand-alone tool for breast cancer screening, and recent results have shown that DW MRI is more useful than conventional imaging in detecting small breast cancer. However, most of these studies were retrospective with inconsistent results. Thus, a prospective multicenter study with standardized acquisition and interpretation protocols in a large population is needed to determine the efficacy of DW MRI for breast cancer screening. The purpose of our study is to determine whether DWI improves the performance of preoperative DCE MRI in detecting clinically occult contralateral breast cancers.
CONDITIONS
Official Title
Screening Contralateral Breast Cancers in Patients With Newly Diagnosed Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged more than 25 years at the time of enrollment
- Women underwent digital mammography and whole-breast ultrasound before MRI
- Women with image-guided biopsy result of invasive breast cancer
- Women who are planning for breast conservation surgery
- Women who will undergo preoperative breast MRI
You will not qualify if you...
- Women aged less than 25 years at the time of enrollment
- Women with image-guided biopsy result of ductal carcinoma in situ or recurrent breast cancer
- Women who underwent lumpectomy before MRI
- Women receiving neoadjuvant chemotherapy or undergoing chemotherapy due to other malignancy
- Pregnant or lactating women
- Women with contraindication to breast MRI, including claustrophobia, renal insufficiency (GFR <60 mL/min/1.73m2), metallic foreign body, history of severe side effects due to MR contrast agent, or inability to tolerate 40 minute scanning time
AI-Screening
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Trial Site Locations
Total: 1 location
1
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
Research Team
W
Woo Kyung Moon, MD, PhD
CONTACT
S
Su Min Ha, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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