Breast CancerNCT04619186
Diffusion-Weighted MRI for Breast Cancer Screening in Women With a Personal History of Breast Cancer
An observational study of Breast Cancer, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 1,694 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Dec 2024to 30 Dec 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women who underwent breast conservation therapy or mastectomy and at increased risk of an interval second breast cancer
Who may be able to join
- 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)
Who cannot join
- Women with signs or symptoms of breast cancer
- Women who had bilateral mastectomy
- 4. Women who had known metastatic disease 5. Pregnant or lactating women 6. Women with claustrophobia or metallic foreign body
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Diffusion-Weighted MRI and Mammography Alone or Combined Mammography and Ultrasonography for Screening Women With a Personal History of Breast Cancer (DIMRISC-2 Study)
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.
Read the detailed description
- Primary objective: to compare the screening performance of DW MRI versus mammography alone or combined mammography and ultrasonography in women with PHBC.
- Secondary objective: to compare the tumor and patient characteristics detected by DW MRI and combined mammography and ultrasonography in women with PHBC.
- This is a prospective, single center, observational cohort study.
- A total of 1694 women will be enrolled in this study.
- Two latest 3.0 T MRI scanners with dedicated 16- or 18-channel bilateral breast coil are used for DW MRI. For DW MRI screening, the high-resolution echo-planar imaging sequence is designed to have an in-plane resolution of 1.3 x 1.3 mm and a slice thickness of 3 mm. Three b values of 0, 800, and 1200 sec/mm2 are used and ADC maps are generated based on the b=0 and 800 sec/mm2 DW MRI data. The DW MRI images are reconstructed into single summation images with maximum-intensity projections (MIPs) in the sagittal and axial planes. In addition, T1-weighted imaging sequence is also obtained with in-plane resolution of 1.0 x 1.0 mm and a slice thickness of 1 mm.
- All patients with PHBC undergo digital two-dimensional mammography and physician-performed whole-breast ultrasonography on the same day. DW MRI and conventional imaging (mammography and ultrasonography) are alternatively scheduled at 6-month intervals and the order has been randomized.
- Mammography alone, combined mammography and ultrasonography, and DW MRI will be interpreted independently according to the Breast Imaging Reporting and Data System (BI-RADS) and likelihood of malignancy (Score range, 0%-100%) by trained radiologists. DW MRI interpretation guidelines to be used in this study are based on both qualitative and quantitative assessments. Radiologists are required to successfully complete a training case series of 100 DW MR studies prior to interpreting the DW MRI.
- A negative examination result is defined as a final assessment BI-RADS category of 1, 2, 3 and a positive examination result is defined as a final assessment BI-RADS category of 4 or 5.
- Biopsies of DW MRI-detected lesions are performed under ultrasonography guidance whenever possible or with MR guidance if there is no correlative ultrasonography finding. Pathology of core or surgical biopsy and 1 year follow up is the reference standard.
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer detection rate (CDR)
Number of detected cancers (invasive cancer and DCIS) /1000 women
Measured: Baseline to up to 1 year
Secondary outcomes (8)
Sensitivity
Number of positive examinations with a tissue diagnosis of cancer within 1 year/All examinations with tissue diagnosis of cancer within the same period
Measured: Baseline to up to 1 year
Specificity
Number of negative examinations without tissue diagnosis of cancer within 1 year/All examinations without tissue diagnosis of cancer within the same period
Measured: Baseline to up to 1 year
Recall rate
Percentage of women screened with recommendation for further imaging prior to next routine examination
Measured: Baseline to up to 1 year
Positive predictive value (PPV)
PPV1: True positive/True positive + False positive
- PPV2: Number of biopsy confirmed cancers/total number of recommendations for biopsy.
- PPV3: Number of biopsy confirmed cancers/total number of biopsies performed
Measured: Baseline to up to 1 year
Accuracy
Proportion of true positive results (both true positive and true negative) in the population
-The area under the (receiver operating characteristic) curve (AUC)
Measured: Baseline to up to 1 year
Interval cancer rate
Breast cancer diagnosed within 1 year of a negative screening result because of clinical symptoms/1000 women
Measured: Baseline to up to 1 year
Characteristics of detected cancers
Tumor size, type, grade, molecular subtype, and lymph node metastasis
Measured: Baseline to up to 1 year
Characteristics of women with DW-MRI detected cancer
Age, menopausal status, breast density, family history
Measured: Baseline to up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start30 Dec 2024 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2026 (estimated)
Why it stopped: Protocol setting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,694 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Woo Kyung Moon, Seoul National University Hospital
- Investigators
- Woo Kyung Moon, MD, PhD, Study chair, Seoul National University Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619186
- Sponsor's protocol ID
- Breast Cancer Screening
- Status last verified
- May 2024
- First submitted
- 30 Oct 2020
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33856137
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Diffusion-Weighted MRI and Mammography Alone or Combined Mammography and Ultrasonography for Screening Women With a Personal History of Breast Cancer (DIMRISC-2 Study)
- ClinicalTrials.gov ID
- NCT04619186
- Acronym / sponsor ID
- Breast Cancer Screening
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Protocol setting
- Enrolment
- 1,694 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 30 Dec 2024 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 6 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Primary objective: to compare the screening performance of DW MRI versus mammography alone or combined mammography and ultrasonography in women with PHBC.
- Secondary objective: to compare the tumor and patient characteristics detected by DW MRI and combined mammography and ultrasonography in women with PHBC.
- This is a prospective, single center, observational cohort study.
- A total of 1694 women will be enrolled in this study.
- Two latest 3.0 T MRI scanners with dedicated 16- or 18-channel bilateral breast coil are used for DW MRI. For DW MRI screening, the high-resolution echo-planar imaging sequence is designed to have an in-plane resolution of 1.3 x 1.3 mm and a slice thickness of 3 mm. Three b values of 0, 800, and 1200 sec/mm2 are used and ADC maps are generated based on the b=0 and 800 sec/mm2 DW MRI data. The DW MRI images are reconstructed into single summation images with maximum-intensity projections (MIPs) in the sagittal and axial planes. In addition, T1-weighted imaging sequence is also obtained with in-plane resolution of 1.0 x 1.0 mm and a slice thickness of 1 mm.
- All patients with PHBC undergo digital two-dimensional mammography and physician-performed whole-breast ultrasonography on the same day. DW MRI and conventional imaging (mammography and ultrasonography) are alternatively scheduled at 6-month intervals and the order has been randomized.
- Mammography alone, combined mammography and ultrasonography, and DW MRI will be interpreted independently according to the Breast Imaging Reporting and Data System (BI-RADS) and likelihood of malignancy (Score range, 0%-100%) by trained radiologists. DW MRI interpretation guidelines to be used in this study are based on both qualitative and quantitative assessments. Radiologists are required to successfully complete a training case series of 100 DW MR studies prior to interpreting the DW MRI.
- A negative examination result is defined as a final assessment BI-RADS category of 1, 2, 3 and a positive examination result is defined as a final assessment BI-RADS category of 4 or 5.
- Biopsies of DW MRI-detected lesions are performed under ultrasonography guidance whenever possible or with MR guidance if there is no correlative ultrasonography finding. Pathology of core or surgical biopsy and 1 year follow up is the reference standard.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who underwent breast conservation therapy or mastectomy and at increased risk of an interval second breast cancer
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- Women with signs or symptoms of breast cancer
- Women who had bilateral mastectomy
- 4. Women who had known metastatic disease 5. Pregnant or lactating women 6. Women with claustrophobia or metallic foreign body
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cancer detection rate (CDR)
Time frame: Baseline to up to 1 year
Number of detected cancers (invasive cancer and DCIS) /1000 women
8 secondary outcomes
Sensitivity
Time frame: Baseline to up to 1 year
Specificity
Time frame: Baseline to up to 1 year
Recall rate
Time frame: Baseline to up to 1 year
Positive predictive value (PPV)
Time frame: Baseline to up to 1 year
Accuracy
Time frame: Baseline to up to 1 year
Interval cancer rate
Time frame: Baseline to up to 1 year
Characteristics of detected cancers
Time frame: Baseline to up to 1 year
Characteristics of women with DW-MRI detected cancer
Time frame: Baseline to up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Derived from this study: PubMed 33856137Ha 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Woo Kyung Moon, MD, PhD study chair
Seoul National University Hosptial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer detection rate (CDR) (time frame: Baseline to up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04619186, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.