NCT05307757

Screening Contralateral Breast Cancers in Patients With Newly Diagnosed Breast Cancer

Recruiting now Last updated 29 May 2024

What this trial tests

trial in Breast Cancer in 1,098 participants. Currently enrolling.

Timeline

1 May 2022

Primary endpoint
31 December 2024

31 January 2026

Quick facts

Lead sponsor	Seoul National University Hospital
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	1,098
Start date	1 May 2022
Primary completion	31 December 2024
Estimated completion	31 January 2026
Sites	1 location across South Korea

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Seoul National University Hospital

Who can join

Adults 25 to 80, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Diffusion-Weighted Magnetic Resonance Imaging for Preoperative Evaluation of Patients With Breast Cancer: Protocol of a Prospective, Multicenter, Observational Cohort Study.
   Park VY, Shin HJ, Kang BJ, Kim MJ, et al · · 2023 · cited 3× · PMID 37272245 · DOI 10.4048/jbc.2023.26.e18
2. Preoperative Diagnosis of Ipsilateral and Contralateral Breast Cancer: Role of Diffusion-weighted MRI.
   Kim HJ, Partridge SC, Lee J, Yoen H, et al · · 2025 · cited 1× · PMID 40492914 · DOI 10.1148/radiol.242423
3. Breast Diffusion-weighted MR Imaging: Current Applications, Insights from Screening, and Future Directions.
   Cho N. · · 2025 · PMID 39924213 · DOI 10.2463/mrms.rev.2024-0142