Carcinoma, Ductal, BreastNCT04498611
Prediction of Upgrade to Invasive Cancer in Patients Diagnosed With Ductal Carcinoma in Situ by Percutaneous Core Needle Biopsy
A study testing contrast-enhanced breast MRI in people with Carcinoma, Ductal, Breast and Invasive Breast Cancer, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
It is considered that whether or not the accompanying invasive cancer classified through MRI images of breast cancer patients identified as Ductal Carcinoma in situ (DCIS) through preoperative tissue biopsy is significantly consistent with the postoperative stage. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Carcinoma, Ductal, Breast, Invasive Breast Cancer, IMAGE
- What is being tested?
- contrast-enhanced breast MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Jul 2020to 15 Aug 2021
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult over 19 years-old
- Breast Ductal Carcinoma in-situ patients who diagnosed preoperative tissue biopsy
- A person who understands this study and agrees with willingness to participate
Who cannot join
- Ductal Carcinoma in-situ which diagnosed excisional biopsy
- When there is no lesion that can be discriminated from magnetic resonance imaging
- Neoadjuvant chemotherapy patients
- Patients who have complication (hematoma, abscess etc.) after preoperative biopsy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Jongno-gu, 03080
About this study
Official title: Prediction of Upgrade to Invasive Cancer in Patients Diagnosed With Ductal Carcinoma in Situ by Percutaneous Core Needle Biopsy: A Development and Validation Study
It is considered that whether or not the accompanying invasive cancer classified through MRI images of breast cancer patients identified as Ductal Carcinoma in situ (DCIS) through preoperative tissue biopsy is significantly consistent with the postoperative stage.
Therefore, this study intend to evaluate the effectiveness as a diagnostic tool that can help determine the axillary lymph node surgery by predicting the possibility of post-operative up-staging using magnetic resonance imagings of breast cancer patients who have been identified as ductal carcinoma in situ and are scheduled for surgery.
Read the detailed description
- To date, there is no significant research data on the value of the Apparent Diffusion Coefficient (ADC) that can distinguish between pure Ductal Carcinoma in situ (pure DCIS) and invasive cancer (DCIS-IC), from June 2019 to 2020 1 Of the 144 patients who obtained Diffusion Weighted images (b=0,800,1200) with 3.0-T MRI equipment and diagnosed with ductal carcinoma in situ on the biopsy, among 144 patients who did not undergo preoperative chemotherapy using a CAD program, the 3-dimensional Apparent Diffusion Coefficient value of the tumor is measured and compared with whether or not there is invasive cancer after surgery, and the optimal Apparent Diffusion Coefficient reference value that can predict the invasive cancer will be retrospectively derived.
- Scheduled MRI tests will be performed on patients enrolled from July 2020, and will be performed using the standard protocols (3T, contrast enhancement and diffuse enhancement images DWI b0,800,1200). Among the MRI images taken, the range of lesions is evaluated in contrast-enhanced T1-highlighted images, and the Apparent Diffusion Coefficient values of the lesions are three-dimensionally mapped using a CAD program and histogram analysis on diffused images. The ADC reference value derived from the retrospective analysis is used to predict prospectively for invasive cancer in all lesions.
- Mastectomy is performed according to the existing surgical method. Axillary lymph node surgery is determined according to the existing decision method (tumor location, size, range, histological grade, etc.).
- Conditions
- Carcinoma, Ductal, Breast, Invasive Breast Cancer, IMAGE
- Being tested
- contrast-enhanced breast MRI
- Medical subject headings
- Carcinoma, Ductal, Breast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contrast-enhanced breast MRIDiagnostic test
Contrast-enhanced MRI will be performed on patients diagnosed with ductal carcinoma in-situ (DCIS) by preoperative biopsy.
| Study group | Role | What they receive |
|---|---|---|
| breast DCIS patients | Experimental | Breast DCIS patients who diagnosed by tissue biopsy except excisional biopsy before surgery, and who agreed to taking the breast MRI. Receives: Diagnostic Test: contrast-enhanced breast MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing of Preoperative MRI and Postoperative histopathologic results
Analysis of the concordance rate (%) of invasive cancers confirmed in the final histopathology after surgery.
Measured: 2 weeks after surgery
Secondary outcomes (1)
Comparing the predicted upstaging rate through the MRI and histopathologic results
Analysis the proportion of up-staging(%) of invasion cancer in the final histopathology.
Measured: 3 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start13 Jul 2020
- Primary completion30 Apr 2021
- Study completion15 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Ductal, BreastStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyeong-Gon Moon, Seoul National University Hospital
- Investigators
- Hyeong-Gon Moon, Study director, Seoul National University of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04498611
- Sponsor's protocol ID
- 2004-219-1119
- Status last verified
- Feb 2022
- First submitted
- 14 Jul 2020
- Last updated
- 14 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mori N, Ota H, Mugikura S, Takasawa C, Tominaga J, Ishida T, Watanabe M, Takase K, Takahashi S. Detection of invasive components in cases of breast ductal carcinoma in situ on biopsy by using apparent diffusion coefficient MR parameters. Eur Radiol. 2013 Oct;23(10):2705-12. doi: 10.1007/s00330-013-2902-2. Epub 2013 Jun 4.
PubMed 23732688Baxter GC, Graves MJ, Gilbert FJ, Patterson AJ. A Meta-analysis of the Diagnostic Performance of Diffusion MRI for Breast Lesion Characterization. Radiology. 2019 Jun;291(3):632-641. doi: 10.1148/radiol.2019182510. Epub 2019 Apr 23.
PubMed 31012817Surov A, Meyer HJ, Wienke A. Can apparent diffusion coefficient (ADC) distinguish breast cancer from benign breast findings? A meta-analysis based on 13 847 lesions. BMC Cancer. 2019 Oct 15;19(1):955. doi: 10.1186/s12885-019-6201-4.
PubMed 31615463Lamb LR, Lehman CD, Oseni TO, Bahl M. Ductal Carcinoma In Situ (DCIS) at Breast MRI: Predictors of Upgrade to Invasive Carcinoma. Acad Radiol. 2020 Oct;27(10):1394-1399. doi: 10.1016/j.acra.2019.09.025. Epub 2019 Nov 4.
PubMed 31699638Lee KH, Han JW, Kim EY, Yun JS, Park YL, Park CH. Predictive factors for the presence of invasive components in patients diagnosed with ductal carcinoma in situ based on preoperative biopsy. BMC Cancer. 2019 Dec 10;19(1):1201. doi: 10.1186/s12885-019-6417-3.
PubMed 31822268Borlinhas F, Conceicao RC, Ferreira HA. Optimal b-values for diffusion kurtosis imaging in invasive ductal carcinoma versus ductal carcinoma in situ breast lesions. Australas Phys Eng Sci Med. 2019 Sep;42(3):871-885. doi: 10.1007/s13246-019-00773-2. Epub 2019 Jul 18.
PubMed 31321627
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Upgrade to Invasive Cancer in Patients Diagnosed With Ductal Carcinoma in Situ by Percutaneous Core Needle Biopsy: A Development and Validation Study
- ClinicalTrials.gov ID
- NCT04498611
- Acronym / sponsor ID
- 2004-219-1119
- Conditions
- Carcinoma, Ductal, Breast, Invasive Breast Cancer, IMAGE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 15 Aug 2021 (actual)
- First posted
- 4 Aug 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.
It is considered that whether or not the accompanying invasive cancer classified through MRI images of breast cancer patients identified as Ductal Carcinoma in situ (DCIS) through preoperative tissue biopsy is significantly consistent with the postoperative stage.
Therefore, this study intend to evaluate the effectiveness as a diagnostic tool that can help determine the axillary lymph node surgery by predicting the possibility of post-operative up-staging using magnetic resonance imagings of breast cancer patients who have been identified as ductal carcinoma in situ and are scheduled for surgery.
Detailed description
- To date, there is no significant research data on the value of the Apparent Diffusion Coefficient (ADC) that can distinguish between pure Ductal Carcinoma in situ (pure DCIS) and invasive cancer (DCIS-IC), from June 2019 to 2020 1 Of the 144 patients who obtained Diffusion Weighted images (b=0,800,1200) with 3.0-T MRI equipment and diagnosed with ductal carcinoma in situ on the biopsy, among 144 patients who did not undergo preoperative chemotherapy using a CAD program, the 3-dimensional Apparent Diffusion Coefficient value of the tumor is measured and compared with whether or not there is invasive cancer after surgery, and the optimal Apparent Diffusion Coefficient reference value that can predict the invasive cancer will be retrospectively derived.
- Scheduled MRI tests will be performed on patients enrolled from July 2020, and will be performed using the standard protocols (3T, contrast enhancement and diffuse enhancement images DWI b0,800,1200). Among the MRI images taken, the range of lesions is evaluated in contrast-enhanced T1-highlighted images, and the Apparent Diffusion Coefficient values of the lesions are three-dimensionally mapped using a CAD program and histogram analysis on diffused images. The ADC reference value derived from the retrospective analysis is used to predict prospectively for invasive cancer in all lesions.
- Mastectomy is performed according to the existing surgical method. Axillary lymph node surgery is determined according to the existing decision method (tumor location, size, range, histological grade, etc.).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| breast DCIS patients | Experimental | Diagnostic Test: contrast-enhanced breast MRIBreast DCIS patients who diagnosed by tissue biopsy except excisional biopsy before surgery, and who agreed to taking the breast MRI. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult over 19 years-old
- Breast Ductal Carcinoma in-situ patients who diagnosed preoperative tissue biopsy
- A person who understands this study and agrees with willingness to participate
Key exclusion criteria (4 listed)
- Ductal Carcinoma in-situ which diagnosed excisional biopsy
- When there is no lesion that can be discriminated from magnetic resonance imaging
- Neoadjuvant chemotherapy patients
- Patients who have complication (hematoma, abscess etc.) after preoperative biopsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| contrast-enhanced breast MRIContrast-enhanced MRI will be performed on patients diagnosed with ductal carcinoma in-situ (DCIS) by preoperative biopsy. | Diagnostic test | breast DCIS patients |
Primary outcome
Comparing of Preoperative MRI and Postoperative histopathologic results
Time frame: 2 weeks after surgery
Analysis of the concordance rate (%) of invasive cancers confirmed in the final histopathology after surgery.
1 secondary outcome
Comparing the predicted upstaging rate through the MRI and histopathologic results
Time frame: 3 weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Background: PubMed 23732688Mori N, Ota H, Mugikura S, Takasawa C, Tominaga J, Ishida T, Watanabe M, Takase K, Takahashi S. Detection of invasive components in cases of breast ductal carcinoma in situ on biopsy by using apparent diffusion coefficient MR parameters. Eur Radiol. 2013 Oct;23(10):2705-12. doi: 10.1007/s00330-013-2902-2. Epub 2013 Jun 4.
- Background: PubMed 31012817Baxter GC, Graves MJ, Gilbert FJ, Patterson AJ. A Meta-analysis of the Diagnostic Performance of Diffusion MRI for Breast Lesion Characterization. Radiology. 2019 Jun;291(3):632-641. doi: 10.1148/radiol.2019182510. Epub 2019 Apr 23.
- Background: PubMed 31615463Surov A, Meyer HJ, Wienke A. Can apparent diffusion coefficient (ADC) distinguish breast cancer from benign breast findings? A meta-analysis based on 13 847 lesions. BMC Cancer. 2019 Oct 15;19(1):955. doi: 10.1186/s12885-019-6201-4.
- Background: PubMed 31699638Lamb LR, Lehman CD, Oseni TO, Bahl M. Ductal Carcinoma In Situ (DCIS) at Breast MRI: Predictors of Upgrade to Invasive Carcinoma. Acad Radiol. 2020 Oct;27(10):1394-1399. doi: 10.1016/j.acra.2019.09.025. Epub 2019 Nov 4.
- Background: PubMed 31822268Lee KH, Han JW, Kim EY, Yun JS, Park YL, Park CH. Predictive factors for the presence of invasive components in patients diagnosed with ductal carcinoma in situ based on preoperative biopsy. BMC Cancer. 2019 Dec 10;19(1):1201. doi: 10.1186/s12885-019-6417-3.
- Background: PubMed 31321627Borlinhas F, Conceicao RC, Ferreira HA. Optimal b-values for diffusion kurtosis imaging in invasive ductal carcinoma versus ductal carcinoma in situ breast lesions. Australas Phys Eng Sci Med. 2019 Sep;42(3):871-885. doi: 10.1007/s13246-019-00773-2. Epub 2019 Jul 18.
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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.
Hyeong-Gon Moon study director
Seoul National University of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing contrast-enhanced breast MRI in people with Carcinoma, Ductal, Breast and Invasive 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 14 Mar 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparing of Preoperative MRI and Postoperative histopathologic results (time frame: 2 weeks after surgery). 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 NCT04498611, which also lists 6 linked publications.
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 14 Mar 2022.