Breast Cancer, Triple Negative Breast Cancer
Conditions
Brief summary
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).
Interventions
DIAGNOSTIC_TESTSodium (Na) Magnetic Resonance Imaging (MRI)
Two Na data will be acquired: 1. FLORET without Inversion Recovery (IR), and 2. FLORET with IR
DIAGNOSTIC_TESTDynamic Contrast- Enhanced (DCE) MRI
DCE MRI will be acquired subsequent to Na MRI to prevent influence of the contrast agent on 23 Na data
Sponsors
National Institutes of Health (NIH)
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Tumor Size | Baseline, 2 Years | Dynamic contrast-enhanced MRI will be used to measure tumor size before and after treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Sodium Concentration (TSC) | Baseline | TSC was directly measured from 23Na images using a phantom calibration |
| Intracellular Sodium Concentration (CIC) | Baseline | CIC is derived from this equation: TSC = ECV · CEC + ICV · CIC + (1 -WF) · Cfat |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Triple Negative Breast Cancer Patients scanned 4 times to assess breast cancer response to NACT with the proposed method.
Sodium (Na) Magnetic Resonance Imaging (MRI): Two Na data will be acquired:
1. FLORET without Inversion Recovery (IR), and
2. FLORET with IR
Dynamic Contrast- Enhanced (DCE) MRI: DCE MRI will be acquired subsequent to Na MRI to prevent influence of the contrast agent on 23 Na data | 2 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Technical Difficulties | 2 |
Baseline characteristics
| Characteristic | Triple Negative Breast Cancer Patients | — |
|---|---|---|
| Age, Continuous | 54.5 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 2 participants | — |
| Sex: Female, Male Female | 2 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
Change in Tumor Size
Dynamic contrast-enhanced MRI will be used to measure tumor size before and after treatment.
Time frame: Baseline, 2 Years
Population: The study was terminated due to technical difficulties; therefore, no follow-ups during or after therapy were performed with only scans at baseline
Secondary
Intracellular Sodium Concentration (CIC)
CIC is derived from this equation: TSC = ECV · CEC + ICV · CIC + (1 -WF) · Cfat
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Triple Negative Breast Cancer Patients | Intracellular Sodium Concentration (CIC) | Participant 1 | 29.6 mM | Standard Deviation 17.9 |
| Triple Negative Breast Cancer Patients | Intracellular Sodium Concentration (CIC) | Participant 2 | 27.2 mM | Standard Deviation 21.1 |
Secondary
Total Sodium Concentration (TSC)
TSC was directly measured from 23Na images using a phantom calibration
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Triple Negative Breast Cancer Patients | Total Sodium Concentration (TSC) | Participant 1 | 47.0 mM | Standard Deviation 11.1 |
| Triple Negative Breast Cancer Patients | Total Sodium Concentration (TSC) | Participant 2 | 39.2 mM | Standard Deviation 15.2 |