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

This study has been completed.
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Paul L. Carson Ph.D, University of Michigan Identifier:
First received: July 23, 2008
Last updated: May 3, 2016
Last verified: May 2016
The purpose of this study is to determine how well changes can be determined in malignant masses from ultrasound scans.

Condition Intervention
Breast Cancers Procedure: Ultrasound Scan Procedure: Mammography and Ultrasound

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Paul L. Carson Ph.D, University of Michigan:

Primary Outcome Measures:
  • 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:
  • 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.

Enrollment: 88
Study Start Date: March 2000
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

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.
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

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 )
Study First Received: July 23, 2008
Last Updated: May 3, 2016

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases processed this record on August 18, 2017