Clinical trial · Interventional
Evaluation of the Diagnostic Performance of MRI±Biopsy to Optimize Resection of Ductal Carcinoma In Situ (DCIS) Breast Cancer
NCT01112254CI-TRIAL-00020667IRCIScompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to evaluate the diagnostic performance of MRI±biopsy to optimize resection of Ductal Carcinoma In Situ (DCIS) breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI±biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MRI±biopsy
- description
- a MRI-guided or CT-guided preoperative biopsy will be performed in case of suspicious enhancement, multiple and large lesions (more than 3 cm from the initial lesion), not viewed on the mammography or breast ultrasound. The surgery type will depends on the MRI ± biopsy results.
- interventionNames
- Procedure: MRI±biopsy
- type
- NO_INTERVENTION
- label
- Standard care
- description
- The patients will be operated without additional exams
Primary outcomes (1)
- measure
- Re-excision rate
- timeFrame
- in the 6 months following randomization
- description
- After histological confirmation of DCIS by stereotactic biopsy the patients will be randomized. In arm 1, a MRI-guided or CT-guided preoperative biopsy will be performed in case of suspicious enhancement, multiple and large lesions (more than 3 cm from the initial lesion), not viewed on the mammography or breast ultrasound. The surgery type will depends on the MRI ± biopsy results. The patients will be operated without additional exams in arm 2.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * T0 or T1 breast DCIS revealed by microcalcifications on mammography + breast ultrasound * Histological confirmation by percutaneous biopsy : strict DCIS or micro-invasive. * Radiological focus \< 30mm and accessible to conservative treatment. * Single microcalcification focus * Age : 18 to 80 years old * Performance Status \< 2 * Patient information and signed informed consent. Exclusion Criteria: * Invasive carcinoma * Non biopsiable microcalcification focus under stereotaxy * Bilateral lesions * Non feasible MRI (claustrophobic, serious allergy, pace-maker, etc.) * Refusal of surgery, including mastectomy if necessary * History of homolateral breast cancer * patient at risk of breast cancer (BRCA1 or 2 mutation or score 5 INSERM table) * Pregnant or possibly pregnant or breastfeeding woman * Person deprived of freedom or under guardianship * Inability to undergo the medical surveillance of the trial for geographical, social or psychological reasons
References
Publications (1)
- DERIVEDBalleyguier C, Dunant A, Ceugnart L, Kandel M, Chauvet MP, Cherel P, Mazouni C, Henrot P, Rauch P, Chopier J, Zilberman S, Doutriaux-Dumoulin I, Jaffre I, Jalaguier A, Houvenaeghel G, Guerin N, Callonnec F, Chapellier C, Raoust I, Mathieu MC, Rimareix F, Bonastre J, Garbay JR. Preoperative Breast Magnetic Resonance Imaging in Women With Local Ductal Carcinoma in Situ to Optimize Surgical Outcomes: Results From the Randomized Phase III Trial IRCIS. J Clin Oncol. 2019 Apr 10;37(11):885-892. doi: 10.1200/JCO.18.00595. Epub 2019 Feb 27. PMID 30811290