Actively Recruiting

Age: 25Years +
FEMALE
NCT04656639

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

Led by Seoul National University Hospital · Updated on 2024-05-29

580

Participants Needed

1

Research Sites

195 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 25Years +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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 such as claustrophobia, renal insufficiency (GFR <60mL/min/1.73m2), metallic foreign body, history of severe side effects from MR contrast agent, or inability to tolerate 40 minute scanning time

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Trial Site Locations

Total: 1 location

1

Seoul National University Hospital

Seoul, South Korea

Actively Recruiting

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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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