Metabolic Sodium MRI to Assess Early Response of Breast Cancer to Neoadjuvant Chemotherapy
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/6/2019 |
| Start Date: | July 25, 2017 |
| End Date: | June 2019 |
| Contact: | Terlika Sood |
| Email: | terlika.sood@nyumc.org |
| Phone: | 212 263 3343 |
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).
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).
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.
We found this trial at
1
site
462 1st Avenue
New York, New York 10010
New York, New York 10010
Principal Investigator: Guillaume Sood, MD
Phone: 212-263-3343
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