Comparison of Ultrasound and Breast MRI for Breast Cancer Detection

Last updated: December 2, 2024
Sponsor: Samsung Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cancer

Breast Cancer

Treatment

Breast MRI for Breast Cancer Detection

Clinical Study ID

NCT05797545
2022-11-076-002
  • Ages 20-75
  • Female
  • Accepts Healthy Volunteers

Study Summary

The goal of this randomized clinical trial is to compare diagnostic results of secondary breast cancer surveillance using breast ultrasound abbreviated MRI and full protocol MRI.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women aged 20-75 with a history of breast cancer (in situ carcinoma or invasivebreast cancer [stage 0-3])

  • Women with a negative resection margin in the pathology results of the last surgicalspecimen from past breast cancer

  • Women with dense breasts with pattern C (heterogeneously dense) or D (extremelydense breasts) using AI-based Lunit INSIGHT for Mammography (version 1.1.4.3, LunitInc.) in the most recent mammography

  • Women who have not had a breast imaging test within 6 months

  • Women who agreed to undergo regular annual mammography, breast ultrasound, andbreast MRI

  • If mammography, ultrasound, or breast MRI was performed within the last 1 year, themost recent test result is normal or positive (BI-RADS 1 or 2)

Exclusion

Exclusion Criteria:

  • Patients with symptoms related to current breast cancer or breast cancer recurrence (palpable mass, bloody or transparent nipple secretion, palpable mass in theaxillary region, abnormal skin changes in the breast or nipple)

  • If you have been diagnosed with regional recurrence (axillary lymph nodes,supraclavicular and subclavian lymph nodes, internal mammary lymph nodes, etc.) ordistant metastases

  • In case of bilateral total mastectomy

  • If women are receiving chemotherapy for cancer in other organs

  • Women during pregnancy or lactation

  • Glomerular filtration rate < 30 mL/min/1.73m2, or patients with renal insufficiencyon dialysis

  • If women have severe claustrophobia

  • If women have a metal prosthesis that is not suitable for MR (e.g. breast tissueexpander, etc.)

  • If there is a history of severe contrast agent side effects (e.g., anaphylactoidreaction, dyspnea, etc.)

Study Design

Total Participants: 1464
Treatment Group(s): 1
Primary Treatment: Breast MRI for Breast Cancer Detection
Phase:
Study Start date:
April 23, 2023
Estimated Completion Date:
May 28, 2028

Study Description

Women who have been treated for breast cancer are at risk of ipsilateral local/regional recurrence or new primary cancers in the contralateral breast, which are associated with increased rates of distant metastases and breast cancer mortality. The goal of post-treatment imaging surveillance is to detect early second breast cancer, which permits interventions to improve survival and maintain quality of life.

Currently, most guidelines consistently recommend annual mammography for women with a personal history of breast cancer (PHBC). However, in women with dense breasts, mammographic sensitivity decreased from a level of 85.7%-88.8% in patients with almost entirely fatty tissue to 62.2%-68.1%. Even more, sensitivity of mammography was lower in women with a PHBC within the initial 5 years after primary breast cancer (PBC) treatment. In addition, dense breasts lead to an increased percentage of interval cancer. Thus, the need for a better surveillance modality has emerged.

In this context, breast US may be considered as a supplemental screening modality because it is widely available, does not need contrast agents, and is of relatively lower cost . A few studies indicate that adding screening US to mammography reduced interval cancer rates for women with dense breasts and enable detection of early-stage cancers at an average of 4.2 cancers per 1000 US examinations. As an another candidate, breast MRI shows high sensitivity and offers the highest cancer detection rate but its routine usage in women with a PHBC is still on debate.

Another possible imaging modality is breast magnetic resonance imaging (MRI). Current National Comprehensive Cancer Network (NCCN) guidelines suggest annual screening with mammography and MRI is recommended for ① women with Breast Cancer Susceptibility Gene (BRCA1 or BRCA2) mutations, ② first-degree family members of carriers of BRCA mutations, ③ women with a lifetime risk of breast cancer greater than 20% based on family history, and ④ women have radiotherapy for thorax at the age of 10-30 years and ⑤ women diagnosed with lobular carcinoma in situ (LCIS), atypical ductal hyperplasia (ADH), or atypical lobular hyperplasia (ALH) by previous biopsy. And, this is based on the results of existing single-center or multi-center prospective studies. Women who underwent breast-conserving surgery for breast cancer before the age of 50 were added to the 2018 new MRI screening group of the American College of Radiology (ACR), and their secondary breast cancer risk is 20% or more. Most women with a history of breast cancer have an intermediate risk (>15% but <20%) of developing breast cancer. Therefore, when most patients are not in the high-risk group, performing conventional MRI (full-protocol MRI, FP-MRI) for all postoperative examinations is not appropriate in terms of cost and time.

Abbreviated MRI (AB-MRI), introduced relatively recently, is a method designed to increase accessibility by reducing time and cost by selectively capturing only some sequences in FP-MRI. Sequence composition can be adjusted in various ways, and image acquisition must be completed within 10 minutes. A number of studies have demonstrated that AB-MRI has comparable diagnostic results to FP-MRI. The most recent paper published in Korea compared the scores of 726 patients with AB-MRI and FP-MRI by performing propensity score matching. The results were comparable in sensitivity, and AB-MR was significantly higher in specificity. Other indicators such as interval cancer rate or Breast Imaging Reporting & Data System (BI-RADS) Category 3 rate did not show significant differences between the two groups. However, all studies are retrospective and there are no prospective data. Since the reported scores of AB-MRI and FP-MRI are comparable, it is difficult to test because the sample size is larger than 18,000 in order to perform a non-inferiority test on diagnostic scores. The purpose of this study was to compare the diagnostic results of secondary breast cancer surveillance using mammography, ultrasound, and MRI in a prospective multicenter study.

Connect with a study center

  • Inje University Busan Paik Hospital

    Busan, BusanJin-Gu 47392
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical center

    Seoul, Gangnam-gu 06351
    Korea, Republic of

    Active - Recruiting

  • Ewha Womans University Medical Center

    Seoul, Yangchun-gu 07985
    Korea, Republic of

    Active - Recruiting

  • Soon Chun Hyang University Hospital Seoul

    Seoul, Yongsan-Gu 04401
    Korea, Republic of

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.