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Clinical Trials/NCT00721903
NCT00721903
Completed
Not Applicable

3D Breast Ultrasound In Predicting Response to Breast Cancer Therapies

University of Michigan1 site in 1 country88 target enrollmentMarch 2000
ConditionsBreast Cancers

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancers
Sponsor
University of Michigan
Enrollment
88
Locations
1
Primary Endpoint
Volume change on spatially registered (aligned) images tracks path. response better than volume change on unregistered images.
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2000
End Date
September 2014
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Paul L. Carson Ph.D

Principal Investigator

University of Michigan

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.

Outcomes

Primary Outcomes

Volume change on spatially registered (aligned) images tracks path. response better than volume change on unregistered images.

Time Frame: 2002-2014

Self explanatory.

Secondary Outcomes

  • Spatially register pre, intra and post treatment ultrasound image volumes of treated tumor.(2002-2014)

Study Sites (1)

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