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



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:November 2009
End Date:June 2013

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


The purpose of this study is:

1. To evaluate the hypothesis: Can PEM Flex Solo II PET scanner ascertain response to
neoadjuvant chemotherapy in patients with breast cancer?

2. To compare the results from the PEM Flex Solo II PET scanner to the standard of care
bilateral breast MRI.


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.

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
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