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RecruitingNCT04656639Updated May 29, 2024

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

An observational study in Breast Cancer, sponsored by Seoul National University Hospital. Recruiting at 1 site in Korea, Republic of. Open to female participants aged 25 Years and older. Per ClinicalTrials.gov, last updated 2024-05-29.

Sponsored by Seoul National University Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started May 2022; still recruiting 4 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
580
Ages
25 Years and older
Sex
Female
01

Study summary

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.

Read the detailed description

Primary objective: to compare the diagnostic performance of DCE MRI vs combination of DWI and DCE MRI for detection of multifocal, multicentric breast cancer in patients planning for breast conservation surgery

Detailed Description

  • This is a multicenter, intraindividual comparative cohort study.
  • A total of 580 women with newly diagnosed breast cancer will be enrolled in this study.
  • Each eligible woman with newly diagnosed invasive breast cancer will undergo DCE MRI and DWI at a 3T MR scanner.
  • Contrast-enhanced MRI and DWI will be interpreted independently according to the Breast Imaging Reporting and Data System (BI-RADS) and likelihood of malignancy (Score range, 0%-100%) by trained radiologists.
  • Multifocal breast cancer is defined as presence of more than 2 separate (≥1.0cm) foci of breast cancer in the same quadrant or within 5 cm of the primary lesion.
  • Multicentric cancer is defined as two or more synchronous ipsilateral neoplasm located in different quadrant or beyond 5 cm from the primary lesion.
  • BI-RADS final assessment score of 4 or 5 are considered to be positive.
  • Pathology of core or surgical biopsy and 2 year follow up is the reference standard.
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Conditions studied

  • Breast Cancer

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03

In context

Breast Neoplasms

12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 580 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
25 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Newly diagnosed breast cancer patients planning for breast conservation surgery

Inclusion criteria

  • Women aged more than 25 years at the time of enrollment
  • Women underwent digital mammography and whole-breast US 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

Exclusion criteria

Exclusion Criteria:

  1. Women aged less than 25 years at the time of enrollment
  2. Women with image-guided biopsy result of ductal carcinoma in situ or recurrent breast cancer
  3. Women who underwent lumpectomy before MRI
  4. Women receiving neoadjuvant chemotherapy or undergoing chemotherapy due to other malignancy
  5. Pregnant or lactating women
  6. Women with contraindication to breast MRI (claustrophobia, renal insufficiency GFR \<60mL/min/1.73m2, metallic foreign body, history of severe side effects due to MR contrast agent, who cannot tolerate 40 minute scanning time etc).
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
580 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Receiver operating characteristic per lesion and breast level

    Area under the curve (AUC)

    Time frame: 2 year after enrollment

Secondary outcomes

  1. Sensitivity per lesion and breast level

    Number of positive examinations with a tissue diagnosis of cancer within 2 year/All examinations with tissue diagnosis of cancer within the same period

    Time frame: 2 year after enrollment

  2. Specificity per lesion and breast level

    Number of negative examinations without tissue diagnosis of cancer within 2 year/All examinations without tissue diagnosis of cancer within the same period

    Time frame: 2 year after enrollment

  3. Positive Predictive value per lesion and breast level

    True positive/True positive + False positive

    Time frame: 2 year after enrollment

  4. Characteristics of detected cancers

    Tumor size, type, grade, molecular subtype, and lymph node metastasis

    Time frame: 2 year after enrollment

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Study locations

1 of 1 sites recruiting
  • Seoul National University Hospital
    Seoul, Korea, Republic of
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04656639
Lead sponsor
Seoul National University Hospital
Responsible party
Woo Kyung Moon (Professor, Seoul National University Hospital) — Principal investigator
First posted
Dec 7, 2020
Start date
May 1, 2022
Primary completion
Dec 31, 2024 (estimated)
Completion
Jan 31, 2026 (estimated)
Last update
May 29, 2024

Study contacts

Woo Kyung Moon, MD, PhD
Contact
moonwk@snu.ac.kr
+82220722584
Su Min Ha, MD, PhD
Contact
su3ha5@hanmail.net
+8220724778
Woo Kyung Moon
study chair · Seoul National University Hosptial

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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