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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):
Daniel Appelbaum, University of Chicago
ClinicalTrials.gov Identifier:
NCT01011946
First received: November 10, 2009
Last updated: July 27, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 Device: Positron Emission Mammography
 Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Staging of Axillary Lymph Nodes Using the PEM Flex Solo II Pet Scanner in Patients With Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 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 and a half years ] [ Designated as safety issue: No ]
    determining the accuracy of FDG positron emission mammography in identifying axillary lymph node metastases from breast cancer


Enrollment: 25
Study Start Date: November 2009
Study Completion Date: May 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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).
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01011946

Locations
United States, Illinois
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Daniel Appelbaum, M.D. The University of Chicago Medical Center
  More Information

No publications provided

Responsible Party: Daniel Appelbaum, Associate Professor, University of Chicago
ClinicalTrials.gov Identifier: NCT01011946     History of Changes
Other Study ID Numbers: 16893A
Study First Received: November 10, 2009
Last Updated: July 27, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013