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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Device: Positron Emission Mammography

• Registration Number: NCT01011946
• Lead Sponsor: University of Chicago

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.

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.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-10
• Study First Submitted QC: 2009-11-10
• Study First Posted: 2009-11-11
• Primary Completion: 2011-03
• Study Completion: 2012-05
• Status Verified: 2015-06
• Results First Submitted: 2015-06-01
• Results First Submitted QC: 2015-06-16
• Last Update Submitted: 2015-06-16
• Results First Posted: 2015-07-09
• Last Update Posted: 2015-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Positron Emission Mammography	Positron Emission Mammography	-

Primary Outcome Measures

Name	Time	Method
Sensitivity and Specificity of FDG Positron Emission Mammography (PEM) in Identifying Axillary Lymph Node (ALN) Metastases From Breast Cancer	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.

Trial Locations

Locations (1)

The University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States