Role of Positron Emission Mammography (PEM) Flex Solo II Positron Emission Tomography (PET) Scanner in Evaluating Neoadjuvant Chemotherapy Response in Patients With Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is: To evaluate the hypothesis: Can PEM Flex Solo II PET scanner ascertain response to neoadjuvant chemotherapy in patients with breast cancer? To compare the results from the PEM Flex Solo II PET scanner to the standard of care bilateral breast MRI.

Detailed Description
-----------------
Subjects will receive bilateral (both sides) breast and axillary PEM scans. All recruited subjects chosen for the study will have biopsy proven breast cancer and are eligible for chemotherapy. They will undergo bilateral breast MRI for staging which is considered standard of care. Breast MRI and PEM scans will be performed at at baseline (phase 0 or pre-operative phase), 2nd MRI and PEM after 1 to 2 weeks of NAC (phase 1) and 3rd MRI and PEM after 1 to 2 weeks of phase 1 (phase 2). DCE-MRI and PEM will be performed not more than 14 days apart within each phase. Cranio-Caudal (CC) and Medial Lateral Oblique (MLO) PEM views will be performed of both the ipsilateral and contralateral breast and axillae by a Mammography Technologist trained in mammographic positioning.

Official Title
-----------------
Role of PEM Flex Solo II PET Scanner in Evaluating Neoadjuvant Chemotherapy Response in Patients With Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Device: PEM Flex Solo II PET Scanner
* Device: MRI scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women 18-75 years old with newly diagnosed breast cancer who are considered candidates for breast conserving surgery (i.e., lumpectomy) Exclusion Criteria: Children (< 18 years old) Pregnant or Lactating women Diabetic patients (Type I or II) Patients who are scheduled for a sentinel node procedure using radioactive Tc-99m within 24 hours of PEM Patients who have NOT undergone a standard of care bilateral breast MRI

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Beast cancer subjects<br>Subject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods | Device: PEM Flex Solo II PET Scanner<br>* Subjects will receive bilateral (both sides) breast and axillary PEM scans.<br>Device: MRI scan<br>* Subjects will receive bilateral (both sides) breast and axillary MRI scans.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Tumor Size | Comparison of tumor size pre chemotherapy and post chemotherapy represents the PEM data. There is no the response with MRI because the study was aborted and very few patients were involved. | 1-2 weeks post treatment onset |