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

Not Applicable

Completed

• Conditions: Breast Cancers
• Interventions: Procedure: Ultrasound Scan; Procedure: Mammography and Ultrasound

• Registration Number: NCT00721903
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study Start: 2000-03
• Study First Submitted: 2008-07-23
• Study First Submitted QC: 2008-07-23
• Study First Posted: 2008-07-25
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-03
• Last Update Posted: 2016-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Subjects	Ultrasound Scan	Ultrasound scan
Cancer	Mammography and Ultrasound	120 women diagnosed by biopsy to have breast cancer will have an ultrasound scan

Primary Outcome Measures

Name	Time	Method
Volume change on spatially registered (aligned) images tracks path. response better than volume change on unregistered images.	2002-2014	Self explanatory.

Secondary Outcome Measures

Name	Time	Method
Spatially register pre, intra and post treatment ultrasound image volumes of treated tumor.	2002-2014	Visually measure separation between two corresponding points in two ultrasound image volumes after registration to verify registration accuracy.

Trial Locations

Locations (1)

University of Michigan Hospital; 🇺🇸 Ann Arbor, Michigan, United States