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

Not Applicable

Terminated

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

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

Registration Number: NCT01931709

Lead Sponsor: University of Washington

Brief Summary: 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: 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).

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 35

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (FDG PET and DCE-MRI)	dynamic contrast-enhanced magnetic resonance imaging	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).
Diagnostic (FDG PET and DCE-MRI)	laboratory biomarker analysis	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).
Diagnostic (FDG PET and DCE-MRI)	fludeoxyglucose F 18	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).
Diagnostic (FDG PET and DCE-MRI)	positron emission tomography	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).

Primary Outcome Measures

Name	Time	Method
Number of Participants With Favorable Pathologic Response at Surgery	At time of 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: 1. No evidence of microscopic invasive tumor at the primary tumor site and in regional axillary lymph nodes = Residual Cancer Burden class 0 (RCB 0) 2. Minimal invasive residual disease at primary tumor site and/or in regional axillary lymph nodes = Residual Cancer Burden class I (RCB I)

Secondary Outcome Measures

Name	Time	Method
Percent Change in PET K1 Between Mid-therapy and Pre-therapy FDG PET Scans and Its Association With Pathologic Response	Baseline to up to 12 weeks (mid-therapy)	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.
Percent Change in Tumor Metabolism / Perfusion Ratio (MRFDG/K1) Between Mid-therapy and Pre-therapy FDG PET Scans and Its Association With Pathologic Response	Baseline to up to 12 weeks (mid-therapy)	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.
Time From Surgery to Breast Cancer Recurrence	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.	Mean (range)
Time of Surgery to Overall Survival	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.	Mean (range)
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	Baseline to up to 12 weeks (mid-therapy)	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.