Three Dimensional (3D) Ultrasound in Predicting Response to Breast Cancer Therapies

This study has been completed.
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Paul L. Carson Ph.D, University of Michigan Identifier:
First received: July 23, 2008
Last updated: May 28, 2015
Last verified: May 2015

July 23, 2008
May 28, 2015
March 2000
September 2014   (final data collection date for primary outcome measure)
Volume change on spatially registered (aligned) images tracks path. response better than volume change on unregistered images. [ Time Frame: 2002-2014 ] [ Designated as safety issue: No ]
Self explanatory.
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Complete list of historical versions of study NCT00721903 on Archive Site
Spatially register pre, intra and post treatment ultrasound image volumes of treated tumor. [ Time Frame: 2002-2014 ] [ Designated as safety issue: No ]
Visually measure separation between two corresponding points in two ultrasound image volumes after registration to verify registration accuracy.
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Three Dimensional (3D) Ultrasound in Predicting Response to Breast Cancer Therapies
3D Breast Ultrasound In Predicting Response to Breast Cancer Therapies

The purpose of this study is to determine how well changes can be determined in malignant masses from ultrasound scans.

To evaluate the proportions of correct diagnosis of response to breast Cancer therapies for localized breast cancer by ultrasound. To develop a model based on patient characteristics, physical exam, and radiologic studies which will predict the possibility that a patient has had a complete pathological response to chemotherapy neoadjuvant therapy.

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Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Breast Cancers
  • Procedure: Ultrasound Scan
    10 female volunteers with normal breast who will be studied to refine imaging techniques and for comparison with patients. To the degree possible, the volunteer group will match the age ranges of the patients with symptoms, initially 30 to 70 years of age.
  • Procedure: Mammography and Ultrasound
    To determine how well from ultrasound scans, changes in malignant masses can be measured, and to whether the use of a dye visible by ultrasound will be useful in evaluating different therapies for breast cancer.
  • Active Comparator: Healthy Subjects
    Healthy Subjects
    Intervention: Procedure: Ultrasound Scan
  • Active Comparator: Cancer
    120 women who have been diagnosed by biopsy to have breast cancer
    Intervention: Procedure: Mammography and Ultrasound
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2014
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Newly diagnosed breast cancer prior to receiving breast cancer therapy.
  • Diagnosis of breast cancer must be confirmed by fine needle aspiration or core biopsy.

Exclusion Criteria:

  • Poorly controlled diabetes.
  • Contralateral mastectomy prior to neoadjuvant chemotherapy.
  • Not a surgical candidate.
  • No previous axillary lymph node dissection.
25 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
2001-0124, UMCC 0005
Paul L. Carson Ph.D, University of Michigan
University of Michigan
National Institutes of Health (NIH)
Principal Investigator: Paul L. Carson, Ph.D. University of Michigan
Principal Investigator: Paul Carson, PhD University of Michigan
University of Michigan
May 2015

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