Diffusion-Weighted MRI for Breast Cancer Screening in Women With a Personal History of Breast Cancer

NCT04619186 | Suspended

• 1 other identifier: Breast Cancer Screening
• Study Type: observational
• Target: 1,694
• Locations: 1 country
• Sites: 1

Brief Summary

Women with personal history of breast cancer (PHBC) are at risk of developing second breast cancers in the conserved and contralateral breast. Because early detection of second breast cancers at the asymptomatic phase can improve relative survival by 17-28%, guidelines recommend annual mammography screening in women with PHBC. However, lower sensitivity and higher interval cancer rates are observed in women with a PHBC compared with women without, especially in women 50 years or younger and those with dense breasts. In a multicenter comparison study of 754 women, MRI screening detected 3.8 additional cancers and ultrasonography detected 2.4 additional cancers, and increased sensitivity over mammography alone. However, the use of breast MRI is limited not only by high costs and long examination time but also by high false-positive findings. In addition, the use of intravenous gadolinium-based contrast agent is contraindicated in women with renal impairment or contrast material allergy contrast. Supplemental ultrasonography in patients with PHBC reports lower sensitivity with high interval cancer rate. Thus, there is a need to develop a more safe, accurate, and cost-effective supplemental imaging modality for screening in women with PHBC. Diffusion-weighted (DW) MRI is an unenhanced fast, functional modality that measures the movement of water molecules to create tissue contrast. Breast malignancies exhibit hindered diffusion and appear hyperintense on DW MRI with low apparent diffusion coefficient (ADC) compared to normal surrounding tissue. Multiple 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 shown that DW MRI has a potential to detect mammography occult breast cancers with less false positives compared to ultrasonography. These observations have led to the consideration of utilizing DW MRI to screen women with PHBC. In Diffusion-weighted MRI for Breast Cancer Screening (DIMRISC-2) study, we hypothesized that the screening performance of high-resolution DW MRI at 3.0 T should be superior to mammography alone or combined mammography and ultrasonography in women with PHBC. In our institution, alternating conventional imaging and DW MRI screening is offered for patients who have undergone breast surgery and at increased risk of an interval second breast cancer.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Cancer detection rate (CDR)

  Number of detected cancers (invasive cancer and DCIS) /1000 women

  Baseline to up to 1 year

Secondary Outcomes (8)

• Sensitivity

  Baseline to up to 1 year

• Specificity

  Baseline to up to 1 year

• Recall rate

  Baseline to up to 1 year

• Positive predictive value (PPV)

  Baseline to up to 1 year

• Accuracy

  Baseline to up to 1 year

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

Women who underwent breast conservation therapy or mastectomy and at increased risk of an interval second breast cancer

You may qualify if:

• Women over 25 years of age at the time of enrollment
• Women who underwent breast conservation therapy or mastectomy and at increased risk of an interval second breast cancer (Age \<50 at first cancer diagnosis; Breast density BI-RADS category 3 and 4; First degree family history; First breast cancer was an interval cancer or symptomatic presentation; First breast cancer was grade 2, 3 or ER and PR negative)

You may not qualify if:

• Women with signs or symptoms of breast cancer
• Women who had bilateral mastectomy
• \. Women who had known metastatic disease 5. Pregnant or lactating women 6. Women with claustrophobia or metallic foreign body

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

• Ha SM, Chang JM, Lee SH, Kim ES, Kim SY, Kim YS, Cho N, Moon WK. Detection of Contralateral Breast Cancer Using Diffusion-Weighted Magnetic Resonance Imaging in Women with Newly Diagnosed Breast Cancer: Comparison with Combined Mammography and Whole-Breast Ultrasound. Korean J Radiol. 2021 Jun;22(6):867-879. doi: 10.3348/kjr.2020.1183. Epub 2021 Apr 1.

  PMID: 33856137 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 Hosptial

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 30, 2020
• First Posted: November 6, 2020
• Study Start: December 30, 2024
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

KR (1)