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

NCT04498611 | Completed

• 1 other identifier: 2004-219-1119
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Ductal, Breast; Invasive Breast Cancer; IMAGE

Outcome Measures

Primary Outcomes (1)

• Comparing of Preoperative MRI and Postoperative histopathologic results

  Analysis of the concordance rate (%) of invasive cancers confirmed in the final histopathology after surgery.

  2 weeks after surgery

Secondary Outcomes (1)

• Comparing the predicted upstaging rate through the MRI and histopathologic results

  3 weeks after surgery

Study Arms (1)

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.

Diagnostic Test: contrast-enhanced breast MRI

Interventions

contrast-enhanced breast MRI DIAGNOSTIC_TEST

Contrast-enhanced MRI will be performed on patients diagnosed with ductal carcinoma in-situ (DCIS) by preoperative biopsy.

breast DCIS patients

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

Location

Related Publications (6)

• 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.

  PMID: 23732688 BACKGROUND

• 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.

  PMID: 31012817 BACKGROUND

• 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.

  PMID: 31615463 BACKGROUND

• 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.

  PMID: 31699638 BACKGROUND

• 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.

  PMID: 31822268 BACKGROUND

• 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.

  PMID: 31321627 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Ductal, Breast

Condition Hierarchy (Ancestors)

Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Ductal, Lobular, and Medullary; Breast Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Hyeong-Gon Moon

  Seoul National University of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: August 4, 2020
• Study Start: July 13, 2020
• Primary Completion: April 30, 2021
• Study Completion: August 15, 2021
• Last Updated: March 14, 2022

Record last verified: 2022-02

Locations

KR (1)