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Prediction of Upgrade to Invasive Cancer in Patients Diagnosed With Ductal Carcinoma in Situ by Percutaneous Core Needle Biopsy

Primary Purpose

Carcinoma, Ductal, Breast, Invasive Breast Cancer, IMAGE

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
contrast-enhanced breast MRI
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Carcinoma, Ductal, Breast

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

breast DCIS patients

Arm Description

Breast DCIS patients who diagnosed by tissue biopsy except excisional biopsy before surgery, and who agreed to taking the breast MRI.

Outcomes

Primary Outcome Measures

Comparing of Preoperative MRI and Postoperative histopathologic results
Analysis of the concordance rate (%) of invasive cancers confirmed in the final histopathology after surgery.

Secondary Outcome Measures

Comparing the predicted upstaging rate through the MRI and histopathologic results
Analysis the proportion of up-staging(%) of invasion cancer in the final histopathology.

Full Information

First Posted
July 14, 2020
Last Updated
February 25, 2022
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04498611
Brief Title
Prediction of Upgrade to Invasive Cancer in Patients Diagnosed With Ductal Carcinoma in Situ by Percutaneous Core Needle Biopsy
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
July 13, 2020 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
August 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Ductal, Breast, Invasive Breast Cancer, IMAGE

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
breast DCIS patients
Arm Type
Experimental
Arm Description
Breast DCIS patients who diagnosed by tissue biopsy except excisional biopsy before surgery, and who agreed to taking the breast MRI.
Intervention Type
Diagnostic Test
Intervention Name(s)
contrast-enhanced breast MRI
Intervention Description
Contrast-enhanced MRI will be performed on patients diagnosed with ductal carcinoma in-situ (DCIS) by preoperative biopsy.
Primary Outcome Measure Information:
Title
Comparing of Preoperative MRI and Postoperative histopathologic results
Description
Analysis of the concordance rate (%) of invasive cancers confirmed in the final histopathology after surgery.
Time Frame
2 weeks after surgery
Secondary Outcome Measure Information:
Title
Comparing the predicted upstaging rate through the MRI and histopathologic results
Description
Analysis the proportion of up-staging(%) of invasion cancer in the final histopathology.
Time Frame
3 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyeong-Gon Moon
Organizational Affiliation
Seoul National University of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Jongno-gu
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
23732688
Citation
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.
Results Reference
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PubMed Identifier
31012817
Citation
Baxter 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.
Results Reference
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PubMed Identifier
31615463
Citation
Surov 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.
Results Reference
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PubMed Identifier
31699638
Citation
Lamb 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.
Results Reference
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PubMed Identifier
31822268
Citation
Lee 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.
Results Reference
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PubMed Identifier
31321627
Citation
Borlinhas 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.
Results Reference
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Prediction of Upgrade to Invasive Cancer in Patients Diagnosed With Ductal Carcinoma in Situ by Percutaneous Core Needle Biopsy

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