Multiparametric MRI as a Non-Invasive Biomarker of the Tumor Microenviroment in Breast Cancer
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Laura Kennedy
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Correlate diffusion weight imaging MRI characteristics
- Status
- Suspended
- Last Updated
- last year
Overview
Brief Summary
This study is looking at how an imaging test could help doctors understand if a patient with early breast cancer will respond to drugs that use the patient's immune system to fight cancer.
Detailed Description
Primary Objective: - To evaluate serial multiparametric MRI as an early marker for tumor immune response to an immune checkpoint inhibitor agent Secondary Objective: * To assess the potential of early treatment imaging changes on MRI to discern final tumor treatment response * To assess the prognostic potential of MRI features Correlative: * To correlate MRI features with immunophenotypes (i.e. hot and cold tumors) * To evaluate the association of MRI features with other known biomarkers of immune checkpoint inhibitor response
Investigators
Laura Kennedy
Sponsor Investigator
Vanderbilt-Ingram Cancer Center
Eligibility Criteria
Inclusion Criteria
- •Women and men at least 18 years of age.
- •Have a new diagnosis of invasive breast cancer with clinical stage I - III disease or regional stage IV with metastasis to the supraclavicular nodes only
- •Hormone receptor negative (estrogen-receptor \< 5% and/or progesterone-receptor \< 5%)
- •Human epidermal growth factor receptor 2 (HER2) negative by immunohistochemistry or fluorescence in situ hybridization (FISH)
- •Enrollment in a neoadjuvant clinical trial that includes the evaluation of immunotherapy as a part of the regimen; patient must be randomized to a treatment arm (including the control arm) prior to enrolling in this study
- •Planning to undergo surgical resection and subsequent adjuvant therapy as per the treatment clinical trial or the clinical provider
- •Have tissue available for additional correlative studies OR planned to undergo an additional pre-treatment biopsy for additional tissue acquisition as per provider or the treatment clinical trial
- •Be a candidate for MRI imaging.
- •Be willing to comply with scheduled visits required for the trial.
- •Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
- •Systemic or locoregional treatment for the current episode of breast cancer prior to baseline breast MRI.
- •Poor visualization of the tumor on the initial breast MRI (investigator discretion)
- •Pregnant or nursing.
Outcomes
Primary Outcomes
Correlate diffusion weight imaging MRI characteristics
Time Frame: Baseline up to about 14 weeks
Correlate dynamic-contrast enhanced MRI characteristics
Time Frame: Baseline up to about 14 weeks
Secondary Outcomes
- Evaluate association between MRI features and pathologic response(Baseline up to about 14 weeks)
- Evaluate association between MRI features and recurrence-free survival(Baseline up to about 14 weeks)