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

NCT04656639 | Recruiting

• 1 other identifier: 2007-206-1145
• Study Type: observational
• Target: 580
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Receiver operating characteristic per lesion and breast level

  Area under the curve (AUC)

  2 year after enrollment

Secondary Outcomes (4)

• Sensitivity per lesion and breast level

  2 year after enrollment

• Specificity per lesion and breast level

  2 year after enrollment

• Positive Predictive value per lesion and breast level

  2 year after enrollment

• Characteristics of detected cancers

  2 year after enrollment

Eligibility Criteria

• Age: 25 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed breast cancer patients planning for breast conservation surgery

You may qualify if:

• 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

You may not qualify if:

• 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 (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).

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Related Publications (1)

• Park VY, Shin HJ, Kang BJ, Kim MJ, Moon WK, Song SE, Ha SM. Diffusion-Weighted Magnetic Resonance Imaging for Preoperative Evaluation of Patients With Breast Cancer: Protocol of a Prospective, Multicenter, Observational Cohort Study. J Breast Cancer. 2023 Jun;26(3):292-301. doi: 10.4048/jbc.2023.26.e18. Epub 2023 Apr 6.

  PMID: 37272245 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Woo Kyung Moon

  Seoul National University Hosptial

  STUDY CHAIR

Central Study Contacts

Woo Kyung Moon, MD, PhD

CONTACT

+82220722584; moonwk@snu.ac.kr

Su Min Ha, MD, PhD

CONTACT

+8220724778; su3ha5@hanmail.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 11, 2020
• First Posted: December 7, 2020
• Study Start: May 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2026
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

KR (1)