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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01011946
First received: November 10, 2009
Last updated: June 16, 2015
Last verified: June 2015

November 10, 2009
June 16, 2015
November 2009
March 2011   (final data collection date for primary outcome measure)
Sensitivity and Specificity of FDG Positron Emission Mammography (PEM) in Identifying Axillary Lymph Node (ALN) Metastases From Breast Cancer [ Time Frame: PEM was performed prior to surgery and LN sampling immediately following surgery ] [ Designated as safety issue: No ]
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.
The primary objective of the study is to determine the possible role of PEM imaging in assessing ALN involvement preoperatively in patients with newly diagnosed breast cancer, prior to surgical intervention. [ Time Frame: one year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01011946 on ClinicalTrials.gov Archive Site
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Staging of Axillary Lymph Nodes Using the PEM Flex Solo II Pet Scanner in Patients With Breast Cancer
Staging of Axillary Lymph Nodes Using the PEM Flex Solo II Pet Scanner in Patients With Breast Cancer
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.
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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Breast Cancer
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).
Experimental: Positron Emission Mammography
Intervention: Device: Positron Emission Mammography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
May 2012
March 2011   (final data collection date for primary outcome measure)

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.
Female
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01011946
16893A
Yes
Not Provided
Not Provided
University of Chicago
University of Chicago
Not Provided
Principal Investigator: Daniel Appelbaum, M.D. The University of Chicago Medical Center
University of Chicago
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP