Three Dimensional (3D) Ultrasound in Predicting Response to Breast Cancer Therapies
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|ClinicalTrials.gov Identifier: NCT00721903|
Recruitment Status : Completed
First Posted : July 25, 2008
Last Update Posted : May 5, 2016
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancers||Procedure: Ultrasound Scan Procedure: Mammography and Ultrasound||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||88 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||3D Breast Ultrasound In Predicting Response to Breast Cancer Therapies|
|Study Start Date :||March 2000|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2014|
Active Comparator: Healthy Subjects
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.
- Volume change on spatially registered (aligned) images tracks path. response better than volume change on unregistered images. [ Time Frame: 2002-2014 ]Self explanatory.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT00721903
|United States, Michigan|
|University of Michigan Hospital|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Paul L. Carson, Ph.D.||University of Michigan|
|Principal Investigator:||Paul Carson, PhD||University of Michigan|