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

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Paul L. Carson Ph.D, University of Michigan
ClinicalTrials.gov Identifier:
NCT00721903
First received: July 23, 2008
Last updated: May 3, 2016
Last verified: May 2016

July 23, 2008
May 3, 2016
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 ClinicalTrials.gov 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.
Interventional
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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 be age-matched to 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
    Ultrasound scan
    Intervention: Procedure: Ultrasound Scan
  • Active Comparator: Cancer
    120 women diagnosed by biopsy to have breast cancer will have an ultrasound scan
    Intervention: Procedure: Mammography and Ultrasound
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
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.
Female
25 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00721903
2001-0124, UMCC 0005, P01CA087634
Yes
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Paul L. Carson Ph.D, University of Michigan
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
University of Michigan
May 2016

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