FDG PET and DCE-MRI in Predicting Response to Treatment in Patients With Breast Cancer

Study Overview
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Brief Summary
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This clinical trial studies fludeoxyglucose F 18 (FDG) positron emission tomography (PET) and dynamic contrast-enhanced (DCE)-magnetic resonance imaging (MRI) in predicting response to treatment in patients with breast cancer. Comparing results of diagnostic procedures done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.

Detailed Description
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PRIMARY OBJECTIVES: I. To determine whether detailed kinetic analysis of FDG PET and magnetic resonance (MR) imaging studies for measures of tumor metabolism and blood perfusion can predict response and outcome for breast cancer patients undergoing neo-adjuvant therapy. II. To compare the in vivo tumor biology associated with responsive and resistant tumors as measured by kinetic changes in FDG PET and MR imaging parameters to tumor subtypes analyzed from assay of pre-therapy biopsy and post-therapy surgical tissue. OUTLINE: Patients undergo FDG PET and DCE-MRI 1-2 weeks before prior to chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).

Official Title
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Quantitative Dynamic PET and MRI and Breast Cancer Therapy

Conditions
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Male Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer

Intervention / Treatment
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* Radiation: fludeoxyglucose F 18
* Device: positron emission tomography
* Device: dynamic contrast-enhanced magnetic resonance imaging
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically confirmed breast cancer, determined to be a candidate for primary systemic (neoadjuvant) therapy and for surgical resection of residual primary tumor following completion of neoadjuvant therapy Primary tumor 2.0 cm or greater, and/or clinical evidence of axillary disease (palpable N1 or N2 or biopsy proven) No obvious contraindications for primary chemotherapy Able to lie still for PET and MRI scanning Able to understand and willing to sign a written informed consent document and a Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines Exclusion Criteria: Serious systemic illness other than breast cancer Contraindication to MRI or history of adverse reaction to gadolinium Evidence of distant disease outside of regional lymph nodes Pregnant Poorly controlled diabetes mellitus (fasting blood glucose > 200) Prior systemic cancer therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (FDG PET and DCE-MRI)<br>Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery). | Radiation: fludeoxyglucose F 18<br>* Undergo FDG PET<br>* Other names: FDG;Device: positron emission tomography<br>* Undergo FDG PET<br>* Other names: tomography, emission computed;Device: dynamic contrast-enhanced magnetic resonance imaging<br>* Undergo DCE-MRI<br>* Other names: DCE-MRI;Other: laboratory biomarker analysis<br>* Correlative studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Favorable Pathologic Response at Surgery | The primary clinical endpoint is dichotomous (yes/no) - Has patient achieved favorable microscopic pathologic response at surgery? This favorable pathologic response is defined as: No evidence of microscopic invasive tumor at the primary tumor site and in regional axillary lymph nodes = Residual Cancer Burden class 0 (RCB 0) Minimal invasive residual disease at primary tumor site and/or in regional axillary lymph nodes = Residual Cancer Burden class I (RCB I) | At time of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in PET K1 Between Mid-therapy and Pre-therapy FDG PET Scans and Its Association With Pathologic Response | Percent change in tumor perfusion between pre-therapy and mid-therapy FDG PET scans as represented by the PET measure K1 (parametric) % change: (Mid-Pre)/Pre, compared between groups of patients who did or did not achieve favorable pathologic response. | Baseline to up to 12 weeks (mid-therapy) | 
| Percent Change in Tumor Metabolism / Perfusion Ratio (MRFDG/K1) Between Mid-therapy and Pre-therapy FDG PET Scans and Its Association With Pathologic Response | Percent change in tumor metabolism / perfusion ratio between pre-therapy and mid-therapy FDG PET scans as represented by the PET measure MRFDG/K1 (parametric) % change: (Mid-Pre)/Pre, compared between groups of patients who did or did not achieve favorable pathologic response. | Baseline to up to 12 weeks (mid-therapy) | 
| Time From Surgery to Breast Cancer Recurrence | Mean (range) | The time from surgery to breast cancer recurrence. If recurrence does not occur during follow-up, the endpoint will be censored at the time of last documented disease-free status. | 
| Time of Surgery to Overall Survival | Mean (range) | Overall survival from time of surgery. If death does not occur during follow-up, the endpoint will be censored at the date of last contact when the patient was verified as alive. | 
| Percent Change in DCE-MRI Peak Percent Enhancement (Peak PE) Between Mid-therapy and Pre-therapy Breast MRI Scans and Its Association With Pathologic Response | Percent change in tumor enhancement between pre-therapy and mid-therapy DCE-MRI scans as represented by the MRI measure Peak PE % change: (Mid-Pre)/Pre, compared between groups of patients who did or did not achieve favorable pathologic response. | Baseline to up to 12 weeks (mid-therapy) |