Staging of Axillary Lymph Nodes Using the PEM Flex Solo II Pet Scanner in Patients With Breast Cancer
1 other identifier
interventional
36
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable breast-cancer
Started Nov 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 10, 2009
CompletedFirst Posted
Study publicly available on registry
November 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedResults Posted
Study results publicly available
July 9, 2015
CompletedJuly 9, 2015
June 1, 2015
1.3 years
November 10, 2009
June 1, 2015
June 16, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Sensitivity and Specificity of FDG Positron Emission Mammography (PEM) in Identifying Axillary Lymph Node (ALN) Metastases From Breast Cancer
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.
PEM was performed prior to surgery and LN sampling immediately following surgery
Study Arms (1)
Positron Emission Mammography
EXPERIMENTALInterventions
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).
Eligibility Criteria
You may qualify if:
- Women 18-75 years old with newly diagnosed breast cancer who are considered candidates for breast conserving surgery (i.e. lumpectomy).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Chicago Medical Center
Chicago, Illinois, 60637, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Daniel Appelbaum
- Organization
- University of Chicago
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Appelbaum, M.D.
The University of Chicago Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2009
First Posted
November 11, 2009
Study Start
November 1, 2009
Primary Completion
March 1, 2011
Study Completion
May 1, 2012
Last Updated
July 9, 2015
Results First Posted
July 9, 2015
Record last verified: 2015-06