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

May 3, 2016 updated by: Paul L. Carson Ph.D, University of Michigan

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume change on spatially registered (aligned) images tracks path. response better than volume change on unregistered images.
Time Frame: 2002-2014
Self explanatory.
2002-2014

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2002-2014

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

National Cancer Institute (NCI)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Paul L. Carson, Ph.D., University of Michigan
  • Principal Investigator: Paul Carson, PhD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2000

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

July 23, 2008

First Submitted That Met QC Criteria

July 23, 2008

First Posted (Estimate)

July 25, 2008

Study Record Updates

Last Update Posted (Estimate)

May 5, 2016

Last Update Submitted That Met QC Criteria

May 3, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2001-0124
  • UMCC 0005 (Other Identifier: Univ. of Michigan Comprehensive Cancer Center)
  • P01CA087634 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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