Clinical trial · Interventional
Prediction of Upgrade to Invasive Cancer in Patients Diagnosed With Ductal Carcinoma in Situ by Percutaneous Core Needle Biopsy
Prediction of Upgrade to Invasive Cancer in Patients Diagnosed With Ductal Carcinoma in Situ by Percutaneous Core Needle Biopsy: A Development and Validation Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Ductal, Breast | Breast Ductal Carcinoma | ALIAS | 0.90 |
| IMAGE | — | UNRESOLVED | — |
| Invasive Breast Cancer | Invasive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| contrast-enhanced breast MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- breast DCIS patients
- description
- Breast DCIS patients who diagnosed by tissue biopsy except excisional biopsy before surgery, and who agreed to taking the breast MRI.
- interventionNames
- Diagnostic Test: contrast-enhanced breast MRI
Primary outcomes (1)
- measure
- Comparing of Preoperative MRI and Postoperative histopathologic results
- timeFrame
- 2 weeks after surgery
- description
- Analysis of the concordance rate (%) of invasive cancers confirmed in the final histopathology after surgery.
Secondary outcomes (1)
- measure
- Comparing the predicted upstaging rate through the MRI and histopathologic results
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (6)
- BACKGROUNDMori 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
- BACKGROUNDBaxter 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
- BACKGROUNDSurov 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
- BACKGROUNDLamb 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
- BACKGROUNDLee 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
- BACKGROUNDBorlinhas 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