Three Dimensional (3D) Ultrasound in Predicting Response to Breast Cancer Therapies
3D Breast Ultrasound In Predicting Response to Breast Cancer Therapies
3 other identifiers
interventional
88
1 country
1
Brief Summary
The purpose of this study is to determine how well changes can be determined in malignant masses from ultrasound scans.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2000
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2000
CompletedFirst Submitted
Initial submission to the registry
July 23, 2008
CompletedFirst Posted
Study publicly available on registry
July 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedMay 5, 2016
May 1, 2016
14.5 years
July 23, 2008
May 3, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Volume change on spatially registered (aligned) images tracks path. response better than volume change on unregistered images.
Self explanatory.
2002-2014
Secondary Outcomes (1)
Spatially register pre, intra and post treatment ultrasound image volumes of treated tumor.
2002-2014
Study Arms (2)
Healthy Subjects
ACTIVE COMPARATORUltrasound scan
Cancer
ACTIVE COMPARATOR120 women diagnosed by biopsy to have breast cancer will have an ultrasound scan
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Newly diagnosed breast cancer prior to receiving breast cancer therapy.
- Diagnosis of breast cancer must be confirmed by fine needle aspiration or core biopsy.
You may not qualify if:
- Poorly controlled diabetes.
- Contralateral mastectomy prior to neoadjuvant chemotherapy.
- Not a surgical candidate.
- No previous axillary lymph node dissection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- National Institutes of Health (NIH)collaborator
- National Cancer Institute (NCI)collaborator
Study Sites (1)
University of Michigan Hospital
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul L. Carson, Ph.D.
University of Michigan
- PRINCIPAL INVESTIGATOR
Paul Carson, PhD
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 23, 2008
First Posted
July 25, 2008
Study Start
March 1, 2000
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
May 5, 2016
Record last verified: 2016-05