Back to resultsThree Dimensional (3D) Ultrasound in Predicting Response to Breast Cancer Therapies
Primary Purpose
Breast Cancers
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound Scan
Mammography and Ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancers
Eligibility Criteria
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.
Sites / Locations
- University of Michigan Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Healthy Subjects
Cancer
Arm Description
Ultrasound scan
120 women diagnosed by biopsy to have breast cancer will have an ultrasound scan
Outcomes
Primary Outcome Measures
Volume change on spatially registered (aligned) images tracks path. response better than volume change on unregistered images.
Self explanatory.
Secondary Outcome Measures
Spatially register pre, intra and post treatment ultrasound image volumes of treated tumor.
Visually measure separation between two corresponding points in two ultrasound image volumes after registration to verify registration accuracy.
Full Information
NCT ID
NCT00721903
First Posted
July 23, 2008
Last Updated
May 3, 2016
Sponsor
University of Michigan
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00721903
Brief Title
Three Dimensional (3D) Ultrasound in Predicting Response to Breast Cancer Therapies
Official Title
3D Breast Ultrasound In Predicting Response to Breast Cancer Therapies
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
March 2000 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine how well changes can be determined in malignant masses from ultrasound scans.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancers
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy Subjects
Arm Type
Active Comparator
Arm Description
Ultrasound scan
Arm Title
Cancer
Arm Type
Active Comparator
Arm Description
120 women diagnosed by biopsy to have breast cancer will have an ultrasound scan
Intervention Type
Procedure
Intervention Name(s)
Ultrasound Scan
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Mammography and Ultrasound
Intervention Description
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 Measure Information:
Title
Volume change on spatially registered (aligned) images tracks path. response better than volume change on unregistered images.
Description
Self explanatory.
Time Frame
2002-2014
Secondary Outcome Measure Information:
Title
Spatially register pre, intra and post treatment ultrasound image volumes of treated tumor.
Description
Visually measure separation between two corresponding points in two ultrasound image volumes after registration to verify registration accuracy.
Time Frame
2002-2014
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul L. Carson, Ph.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul Carson, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Three Dimensional (3D) Ultrasound in Predicting Response to Breast Cancer Therapies
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