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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01011946
• Other study ID #: 16893A
• Status: Completed
• Phase: N/A
• First received: November 10, 2009
• Last updated: June 16, 2015
• Start date: November 2009
• Est. completion date: May 2012

Study information

• Verified date: June 2015
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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).

Locations

Country	Name	City	State
United States	The University of Chicago Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No