- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04656639
Diffusion-Weighted MRI for Diagnosis of Multifocal, Multicentric Breast Cancer
March 23, 2022 updated by: Woo Kyung Moon, Seoul National University Hospital
Detection of multifocal, multicentric breast cancer in patients with breast cancer affects surgical decision.
Histology-proven additional cancer foci have been reported to be detected in 21.0% to 63.0% of affected breasts in women thought to have localized cancer based on clinical assessment and mammography.
Dynamic contrast-enhanced (DCE) MRI is often applied in the preoperative local staging of breast cancer due to its high sensitivity and identifies additional foci that would have otherwise remained undetected on clinical assessment and conventional imaging (mammography and ultrasonography).
However, DCE MRI is limited in use due to its low specificity with high false positive rate, causing unnecessary and incorrect conversion to more extensive surgery.
Diffusion-weighted MRI (DWI) is a fast, functional MRI technique 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 DWI with low apparent diffusion coefficient (ADC) values compared to normal surrounding tissue or benign tumors.
Multiple studies including one prospective multi-center trial showed that DWI can reduce unnecessary benign biopsies of suspicious mammographic or DCE MRI-detected lesions and DWI is now considered as an important part of multi-parametric breast MRI protocols.
However, little is known about the role of DWI as an adjunct to DCE MRI in the local staging of women with breast cancer.
The purpose of our study is to determine whether DWI improves the performance of preoperative DCE MRI in the evaluation of additional lesions in breast cancer patients.
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
Primary objective: to compare the diagnostic performance of DCE MRI vs combination of DWI and DCE MRI for detection of multifocal, multicentric breast cancer in patients planning for breast conservation surgery
Detailed Description
- This is a multicenter, intraindividual comparative cohort study.
- A total of 580 women with newly diagnosed breast cancer will be enrolled in this study.
- Each eligible woman with newly diagnosed invasive breast cancer will undergo DCE MRI and DWI at a 3T MR scanner.
- Contrast-enhanced MRI and DWI 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.
- Multifocal breast cancer is defined as presence of more than 2 separate (≥1.0cm) foci of breast cancer in the same quadrant or within 5 cm of the primary lesion.
- Multicentric cancer is defined as two or more synchronous ipsilateral neoplasm located in different quadrant or beyond 5 cm from the primary lesion.
- BI-RADS final assessment score of 4 or 5 are considered to be positive.
- Pathology of core or surgical biopsy and 2 year follow up is the reference standard.
Study Type
Observational
Enrollment (Anticipated)
580
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of
- Seoul National University Hospital
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Contact:
- Woo Kyung Moon, MD, PhD
- Email: moonwk1963@gmail.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Newly diagnosed breast cancer patients planning for breast conservation surgery
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Receiver operating characteristic per lesion and breast level
Time Frame: 2 year after enrollment
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Area under the curve (AUC)
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2 year after enrollment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity per lesion and breast level
Time Frame: 2 year after enrollment
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Number of positive examinations with a tissue diagnosis of cancer within 2 year/All examinations with tissue diagnosis of cancer within the same period
|
2 year after enrollment
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Specificity per lesion and breast level
Time Frame: 2 year after enrollment
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Number of negative examinations without tissue diagnosis of cancer within 2 year/All examinations without tissue diagnosis of cancer within the same period
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2 year after enrollment
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Positive Predictive value per lesion and breast level
Time Frame: 2 year after enrollment
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True positive/True positive + False positive
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2 year after enrollment
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Characteristics of detected cancers
Time Frame: 2 year after enrollment
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Tumor size, type, grade, molecular subtype, and lymph node metastasis
|
2 year after enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Woo Kyung Moon, Seoul national university hosptial
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 1, 2022
Primary Completion (Anticipated)
May 31, 2023
Study Completion (Anticipated)
January 31, 2026
Study Registration Dates
First Submitted
October 11, 2020
First Submitted That Met QC Criteria
December 4, 2020
First Posted (Actual)
December 7, 2020
Study Record Updates
Last Update Posted (Actual)
April 4, 2022
Last Update Submitted That Met QC Criteria
March 23, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2007-206-1145
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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