Clinical trial · Interventional
MRI in Predicting Early Response to Chemotherapy in Patients With Locally Advanced Breast Cancer
Neo Comice Pilot; Efficacy of Advanced Semi-automated Functional Magnetic Resonance (MR) Imaging in the Early Prediction of Response of Locally Advanced Breast Cancer to Neoadjuvant Chemotherapy
NCT00978770CI-TRIAL-00011619completedPhase 2ClinicalTrials.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)
RATIONALE: Diagnostic procedures such as MRI scans may help predict early response to treatment in patients with breast cancer undergoing chemotherapy. PURPOSE: This phase II trial is studying MRI in predicting early response to chemotherapy in patients with locally advanced 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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| diffusion-weighted magnetic resonance imaging | Procedure | — | UNRESOLVED |
| dynamic contrast-enhanced magnetic resonance imaging | Procedure | — | UNRESOLVED |
| magnetic resonance spectroscopic imaging | Procedure | — | UNRESOLVED |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| systemic chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Failed scan rate (i.e., the number of scans that failed protocol) grouped by cause, including patient refusal, protocol violation in timing, major errors in scan protocols, and minor errors in scan protocol
- measure
- Failed automated MRI-scan data-analysis rate (i.e., number of scans that required manual reading and number of protocol-compliant scans that were unreadable, subdivided according to whether the scans were technically compliant or not)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Newly diagnosed, histologically proven breast cancer * Stage T2-4B, N0-3C, and M0 disease * Locally advanced primary disease * Underwent both x-ray mammography and breast ultrasound scanning during the current treatment episode * Scheduled for neoadjuvant chemotherapy PATIENT CHARACTERISTICS: * Not pregnant or nursing * Medically stable * No renal failure * No serious breast trauma within the past 3 months * No known allergic reaction associated with previous administration of a paramagnetic contrast agent * No known contraindication to magnetic resonance (MR) scanning * Must pass the normal safety requirements of MR, particularly pacemakers and cardiac defibrillators * No disability preventing MR scanning in the prone position * No body habitus incompatible with MR system entry PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior chemotherapy * No prior surgery or radiotherapy for cancer in the ipsilateral breast * More than 4 months since prior surgery to the ipsilateral breast for benign breast disease
References
Publications (0)
Data not yet available
No reference posted for this study.