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

This study has been completed.
Information provided by (Responsible Party):
University of Chicago Identifier:
First received: November 10, 2009
Last updated: June 16, 2015
Last verified: June 2015
The purpose of this study is to determine if PEM scan can improve axillary lymph node staging by assessing if they are involved by cancer. Your doctor may refer you for a PEM scan, PEM stands for positron emission mammography, a relatively new and advanced application of positron emission tomography or PET scanning. For decades, PET has helped doctors diagnose and treat disease.

Condition Intervention
Breast Cancer
Device: Positron Emission Mammography

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Staging of Axillary Lymph Nodes Using the PEM Flex Solo II Pet Scanner in Patients With Breast Cancer

Resource links provided by NLM:

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Sensitivity and Specificity of FDG Positron Emission Mammography (PEM) in Identifying Axillary Lymph Node (ALN) Metastases From Breast Cancer [ Time Frame: PEM was performed prior to surgery and LN sampling immediately following surgery ]
    Based on FDG Positron Emission Mammography (PEM) image, a breast region was classified as "normal" or "abnormal". Lymph Node (LN) sampling and histopathology determined true positives and true negatives.

Enrollment: 36
Study Start Date: November 2009
Study Completion Date: May 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Positron Emission Mammography Device: Positron Emission Mammography
Patients will receive bilateral (both sides) breast and axillary PEM scans, bilateral mammography, DCE-MRI, US of the breast and axilla (the side of the affected breast), and ultrasound guided biopsy of axillary lymph node if suspicious. Various PEM views will be performed on both your breast and axilla (underarm).

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.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01011946

United States, Illinois
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Principal Investigator: Daniel Appelbaum, M.D. The University of Chicago Medical Center
  More Information

Responsible Party: University of Chicago Identifier: NCT01011946     History of Changes
Other Study ID Numbers: 16893A
Study First Received: November 10, 2009
Results First Received: June 1, 2015
Last Updated: June 16, 2015

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases processed this record on May 25, 2017