NCT04656639

Diffusion-Weighted MRI for Diagnosis of Multifocal, Multicentric Breast Cancer

Recruiting now Last updated 29 May 2024

What this trial tests

trial in Breast Cancer in 580 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	580
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

25 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Detection of multifocal, multicentric breast cancer in patients with breast cancer affects surgical decision. Histology-proven additional cancer foci have been reported to be detected in 21.0% to 63.0% of affected breasts in women thought to have localized cancer based on clinical assessment and mammography. Dynamic contrast-enhanced (DCE) MRI is often applied in the preoperative local staging of breast cancer due to its high sensitivity and identifies additional foci that would have otherwise remained undetected on clinical assessment and conventional imaging (mammography and ultrasonography). However, DCE MRI is limited in use due to its low specificity with high false positive rate, causing unnecessary and incorrect conversion to more extensive surgery. Diffusion-weighted MRI (DWI) is a fast, functional MRI technique 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 DWI with low apparent diffusion coefficient (ADC) values compared to normal surrounding tissue or benign tumors. Multiple studies including one prospective multi-center trial showed that DWI can reduce unnecessary benign biopsies of suspicious mammographic or DCE MRI-detected lesions and DWI is now considered as an important part of multi-parametric breast MRI protocols. However, little is known about the role of DWI as an adjunct to DCE MRI in the local staging of women with breast cancer. The purpose of our study is to determine whether DWI improves the performance of preoperative DCE MRI in the evaluation of additional lesions in breast cancer patients.

Publications & conference data

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

1. Update on DWI for Breast Cancer Diagnosis and Treatment Monitoring.
   Gullo RL, Partridge SC, Shin HJ, Thakur SB, et al · · 2024 · cited 32× · PMID 37850579 · DOI 10.2214/ajr.23.29933
2. 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
3. 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
4. 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