Screening Contralateral Breast Cancers in Patients With Newly Diagnosed Breast Cancer

NCT05307757 | Recruiting

• 1 other identifier: Contralateral Screening
• Study Type: observational
• Target: 1,098
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• The area under the (receiver operating characteristic) curve (AUC) per lesion and breast level

  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 - 80 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Newly Diagnosed Breast Cancer

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, MD, PhD

  Seoul National University Hospital

  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
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 1, 2022
• 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)