Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Laura Kennedy
With
National Cancer Institute (NCI)
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
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
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.
You may not be if
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)
