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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00721903
Recruitment Status : Completed
First Posted : July 25, 2008
Last Update Posted : May 5, 2016
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Paul L. Carson Ph.D, University of Michigan

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

Condition or disease Intervention/treatment
Breast Cancers Procedure: Ultrasound Scan Procedure: Mammography and Ultrasound

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 3D Breast Ultrasound In Predicting Response to Breast Cancer Therapies
Study Start Date : March 2000
Primary Completion Date : September 2014
Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Healthy Subjects
Ultrasound scan
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 be age-matched to patients with symptoms, initially 30 to 70 years of age.
Active Comparator: Cancer
120 women diagnosed by biopsy to have breast cancer will have an ultrasound scan
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.

Primary Outcome Measures :
  1. Volume change on spatially registered (aligned) images tracks path. response better than volume change on unregistered images. [ Time Frame: 2002-2014 ]
    Self explanatory.

Secondary Outcome Measures :
  1. Spatially register pre, intra and post treatment ultrasound image volumes of treated tumor. [ Time Frame: 2002-2014 ]
    Visually measure separation between two corresponding points in two ultrasound image volumes after registration to verify registration accuracy.

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Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00721903

United States, Michigan
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Principal Investigator: Paul L. Carson, Ph.D. University of Michigan
Principal Investigator: Paul Carson, PhD University of Michigan

Responsible Party: Paul L. Carson Ph.D, Principal Investigator, University of Michigan Identifier: NCT00721903     History of Changes
Other Study ID Numbers: 2001-0124
UMCC 0005 ( Other Identifier: Univ. of Michigan Comprehensive Cancer Center )
P01CA087634 ( U.S. NIH Grant/Contract )
First Posted: July 25, 2008    Key Record Dates
Last Update Posted: May 5, 2016
Last Verified: May 2016

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