N/A
N=36
Staging of Axillary Lymph Nodes Using the PEM Flex Solo II Pet Scanner in Patients With Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01011946 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcome: Primary: Sensitivity and Specificity of FDG Positron Emission Mammography (PEM) in Identifying Axillary Lymph Node (ALN) Metastases From Breast Cancer — 83.3; 52.0 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Positron Emission Mammography (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Chicago
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity and Specificity of FDG Positron Emission Mammography (PEM) in Identifying Axillary Lymph Node (ALN) Metastases From Breast Cancer |
83.3; 52.0 | — |
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.
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 at UC.
Data sourced from ClinicalTrials.gov (NCT01011946). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.