Multiparametric MRI as a Non-Invasive Biomarker of the Tumor Microenviroment
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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:
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To assess the potential of early treatment imaging changes on MRI to discern final tumor treatment response
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To assess the prognostic potential of MRI features
Correlative:
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To correlate MRI features with immunophenotypes (i.e. hot and cold tumors)
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To evaluate the association of MRI features with other known biomarkers of immune checkpoint inhibitor response
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Advanced Pathology Breast magnetic resonance imaging (MRI) as a preliminary predictive biomarker for breast cancer treatment response. |
Other: Tempus assay
Blood collection
Other: Advanced pathology 1
Tissue procurement (from diagnostic biopsy)
Other: Advanced pathology 2
Tissue procurement (from research biopsy)
|
Outcome Measures
Primary Outcome Measures
- Correlate dynamic-contrast enhanced MRI characteristics [Baseline up to about 14 weeks]
- Correlate diffusion weight imaging MRI characteristics [Baseline up to about 14 weeks]
Secondary Outcome Measures
- 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]
Eligibility Criteria
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
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Hormone receptor negative (estrogen-receptor < 5% and/or progesterone-receptor < 5%)
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Human epidermal growth factor receptor 2 (HER2) negative by immunohistochemistry or fluorescence in situ hybridization (FISH)
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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
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Planning to undergo surgical resection and subsequent adjuvant therapy as per the treatment clinical trial or the clinical provider
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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
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Be a candidate for MRI imaging.
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Be willing to comply with scheduled visits required for the trial.
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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.
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Poor visualization of the tumor on the initial breast MRI (investigator discretion)
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Pregnant or nursing.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37232 |
Sponsors and Collaborators
- Laura Kennedy
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Laura Kennedy, MD, PhD, Vanderbilt Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VICC BRE 20104
- P50CA098131