ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01011946
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01011946
Recruitment Status : Completed
First Posted : November 11, 2009
Results First Posted : July 9, 2015
Last Update Posted : July 9, 2015
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition Breast Cancer
Intervention Device: Positron Emission Mammography
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Positron Emission Mammography
Hide Arm/Group Description 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).
Period Title: Overall Study
Started 36
Completed 33
Not Completed 3
Reason Not Completed
Transferred to another hospital             2
No pathological lab value             1
Arm/Group Title Positron Emission Mammography
Hide Arm/Group Description 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).
Overall Number of Baseline Participants 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants
57.4  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Female
36
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Sensitivity and Specificity of FDG Positron Emission Mammography (PEM) in Identifying Axillary Lymph Node (ALN) Metastases From Breast Cancer
Hide Description 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.
Time Frame PEM was performed prior to surgery and LN sampling immediately following surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Positron Emission Mammography
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 33
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
Sensitivity
83.3
(51.6 to 97.9)
Specificity
52.0
(31.3 to 72.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Positron Emission Mammography
Hide Arm/Group Description 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).
All-Cause Mortality
Positron Emission Mammography
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Positron Emission Mammography
Affected / at Risk (%)
Total   0/36 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Positron Emission Mammography
Affected / at Risk (%)
Total   0/36 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Daniel Appelbaum
Organization: University of Chicago
Phone: (773) 834-2012
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01011946     History of Changes
Other Study ID Numbers: 16893A
First Submitted: November 10, 2009
First Posted: November 11, 2009
Results First Submitted: June 1, 2015
Results First Posted: July 9, 2015
Last Update Posted: July 9, 2015