Trial Title:
Comparison of Ultrasound and Breast MRI for Breast Cancer Detection
NCT ID:
NCT05797545
Condition:
Breast Neoplasms
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Mass Screening
Ultrasonography
Magnetic Resonance Imaging
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Breast MRI for Breast Cancer Detection
Description:
Comparison of diagnostic results of abbreviated breast MRI and full protocol MRI for
secondary breast cancer surveillance
Arm group label:
Abbreviated Breast MRI for Breast Cancer Detection
Arm group label:
Full Protocol MRI for Breast Cancer Detection
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.
Detailed 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Women aged 20-75 with a history of breast cancer (in situ carcinoma or invasive
breast cancer [stage 0-3])
- Women with a negative resection margin in the pathology results of the last surgical
specimen from past breast cancer
- Women with dense breasts with pattern C (heterogeneously dense) or D (extremely
dense breasts) using AI-based Lunit INSIGHT for Mammography (version 1.1.4.3, Lunit
Inc.) 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, and
breast MRI
- If mammography, ultrasound, or breast MRI was performed within the last 1 year, the
most recent test result is normal or positive (BI-RADS 1 or 2)
Exclusion Criteria:
- Patients with symptoms related to current breast cancer or breast cancer recurrence
(palpable mass, bloody or transparent nipple secretion, palpable mass in the
axillary 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.) or
distant 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 insufficiency
on dialysis
- If women have severe claustrophobia
- If women have a metal prosthesis that is not suitable for MR (e.g. breast tissue
expander, etc.)
- If there is a history of severe contrast agent side effects (e.g., anaphylactoid
reaction, dyspnea, etc.)
Gender:
Female
Minimum age:
20 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Inje University Busan Paik Hospital
Address:
City:
Busan
Zip:
47392
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Yung Mi Park
Facility:
Name:
Samsung Medical center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Eun Sook Ko
Phone:
01085284679
Email:
mathilda0330@gmail.com
Facility:
Name:
Ewha Womans University Medical Center
Address:
City:
Seoul
Zip:
07985
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Jin Jung
Facility:
Name:
Soon Chun Hyang University Hospital Seoul
Address:
City:
Seoul
Zip:
04401
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Yun Woo Jang
Start date:
April 23, 2023
Completion date:
May 28, 2028
Lead sponsor:
Agency:
Samsung Medical Center
Agency class:
Other
Source:
Samsung Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05797545
