Clinical trial · Interventional
Metabolic Sodium MRI to Assess Early Response of Breast Cancer to Neoadjuvant Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): technical difficulties for scans on the research MRI system
Summary
Brief summary (as posted)
Neoadjuvant chemotherapy (NACT) is administered to treat invasive breast cancer before surgery. It offers the opportunity to evaluate tumor response to treatment in aggressive disease, and guide additional therapies for patients with inadequate response, if detected early. Investigators propose to develop a sodium breast MRI technique that will allow to assess the early metabolic response of breast cancer to NACT, occurring before late structural changes can be detected with standard MRI. This study will scan 12 patients using 1H/23Na MRI at 7 T and DCE MRI with triple-negative breast cancer undergoing AC-T therapy (2 months of Adriamycin + Cyclophosphamide, then 3 months of Taxol): at baseline (pre-NACT); after the first AC cycle (2 weeks); after AC treatment (2 months); after complete NACT (5 months, pre-surgery).
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dynamic Contrast- Enhanced (DCE) MRI | Diagnostic Test | — | UNRESOLVED |
| Sodium (Na) Magnetic Resonance Imaging (MRI) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Triple Negative Breast Cancer Patients
- description
- scanned 4 times to assess breast cancer response to NACT with the proposed method.
- interventionNames
- Diagnostic Test: Sodium (Na) Magnetic Resonance Imaging (MRI)
- Diagnostic Test: Dynamic Contrast- Enhanced (DCE) MRI
Primary outcomes (1)
- measure
- Change in Tumor Size
- timeFrame
- Baseline, 2 Years
- description
- Dynamic contrast-enhanced MRI will be used to measure tumor size before and after treatment.
Secondary outcomes (2)
- measure
- Total Sodium Concentration (TSC)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women with no sign of breast cancer as controls * Non-pregnant and non-lactating * Ability to understand and willingness to sign a written consent Exclusion Criteria: * Contra-indications to MRI (i.e., ferromagnetic prostheses, metallic surgical implants that are not compatible with an MRI machine, claustrophobia etc.) * Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient. * Pregnant or lactating women, women using hormonal treatment in the 6 months prior to the study. * Women with history of breast disease, previous breast surgery, or breast implants. * Patients with a currently active second malignancy other than non-melanoma skin cancers. Patients are not considered to have a currently active malignancy if they have completed therapy and are free of disease for 3 years. * Psychiatric illness or other conditions and circumstances which could prevent the patient from being compliant with the protocol.
References
Publications (0)
Data not yet available