Clinical trial · Observational
Screening MRI for Cancer Recurrence in Patients Treated With Breast Conserving Therapy
NCT01257152CI-TRIAL-00021837completedClinicalTrials.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)
A prospective, multicenter study: * Primary objective: to assess the diagnostic yield of screening MRI compared to physical examination, mammography or ultrasonography in the detection of recurrence in patients treated with breast conserving therapy * Secondary objective: to describe the size, type, grade, and nodal status of cancers seen only on MRI and to estimate the rate of benign biopsies and short interval follow-up induced only by MRI in this population.
Conditions
Conditions (2)
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neoplasm Recurrence, Local | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Diagnostic yield of screening breast MRI
- timeFrame
- Three years after the first screening MRI
Secondary outcomes (1)
- measure
- Sensitivity, specificity, negative predictive value, and positive predictive value of screening mammography, ultrasonography, and MRI
- timeFrame
- Three years after the first screening examinations
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Women ≥ 20 years in age; * Women who underwent breast-conserving surgery for invasive breast cancer, whose final margins were negative and who finished radiation therapy at least 6 months prior to this study; * No history of breast biopsy of the breast within 6 months prior to this study; * Signed study-specific informed consent prior to registration; * Has not had contralateral mastectomy; * No known metastatic disease; * Not pregnant or lactating; * No present signs or symptoms of breast cancer \[no palpable mass(es), bloody or spontaneous clear nipple discharge, axillary mass, or abnormal skin changes in the breast(s) or nipple(s)\]. * No contraindications to MRI examination. * No prior MRI, US or mammography within the 6 months prior to the study. Exclusion Criteria: * Had a screening contrast-enhanced breast MRI within the past 24 months or diagnostic contrast-enhanced MRI on any study breasts within the past 12 months; * Had breast surgery and/or a core biopsy on the study breast(s) performed within the prior 6 months on the study * Currently receiving chemotherapy \[with exception to participant with personal history of cancer, and on chemoprevention with Tamoxifen, Evista (Raloxifene), Arimidex (Anastrozole), Aromasin (Exemestane) or other aromatase inhibitor\]; * Participant with severely impaired renal function with estimated glomerular filtration rate (GFR) \< 30 mL/min/1.73m2 and/or on dialysis.
References
Publications (0)
Data not yet available
No reference posted for this study.