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Staging of Axillary Lymph Nodes Using the PEM Flex Solo II Pet Scanner in Patients With Breast Cancer

Phase 0
18 Years
75 Years
Not Enrolling
Breast Cancer

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Trial Information

Staging of Axillary Lymph Nodes Using the PEM Flex Solo II Pet Scanner in Patients With Breast Cancer

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 at UC.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary objective of the study is to determine the possible role of PEM imaging in assessing ALN involvement preoperatively in patients with newly diagnosed breast cancer, prior to surgical intervention.

Outcome Description:

determining the accuracy of FDG positron emission mammography in identifying axillary lymph node metastases from breast cancer

Outcome Time Frame:

one and a half years

Safety Issue:


Principal Investigator

Daniel Appelbaum, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Chicago Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

November 2009

Completion Date:

May 2012

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms



The University of Chicago Medical Center Chicago, Illinois  60637-1470