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Role of Positron Emission Mammography (PEM) Flex Solo II Positron Emission Tomography (PET) Scanner in Evaluating Neoadjuvant Chemotherapy Response in Patients With Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kirti Kulkarni, University of Chicago
ClinicalTrials.gov Identifier:
NCT01012440
First received: June 25, 2009
Last updated: February 7, 2013
Last verified: February 2013
History of Changes
  Purpose

The purpose of this study is:

  1. To evaluate the hypothesis: Can PEM Flex Solo II PET scanner ascertain response to neoadjuvant chemotherapy in patients with breast cancer?
  2. To compare the results from the PEM Flex Solo II PET scanner to the standard of care bilateral breast MRI.

Condition Intervention Phase
Breast Cancer
 Device: PEM Flex Solo II PET Scanner
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Role of PEM Flex Solo II PET Scanner in Evaluating Neoadjuvant Chemotherapy Response in Patients With Breast Cancer

Resource links provided by NLM:

Drug Information available for: Diazepam
U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • To measure response to neoadjuvant chemotherapy in patients with breast cancer. [ Time Frame: one and a half years ] [ Designated as safety issue: No ]
    analysis of three patients pilot data in progress


Enrollment: 25
Study Start Date: November 2009
Study Completion Date: May 2012
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: PEM Flex Solo II PET Scanner
    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.
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01012440

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

No publications provided

Responsible Party: Kirti Kulkarni, Assistant Professor of Radiology, University of Chicago
ClinicalTrials.gov Identifier: NCT01012440     History of Changes
Other Study ID Numbers: 16895A
Study First Received: June 25, 2009
Last Updated: February 7, 2013
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 June 18, 2013