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

Breast Cancers Clinical Trial

Official title:

3D Breast Ultrasound In Predicting Response to Breast Cancer Therapies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00721903
• Other study ID #: 2001-0124
• Secondary ID: UMCC 0005P01CA08
• Status: Completed
• Phase: N/A
• First received: July 23, 2008
• Last updated: May 3, 2016
• Start date: March 2000
• Est. completion date: September 2014

Study information

• Verified date: May 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine how well changes can be determined in malignant masses from ultrasound scans.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancers
• Breast Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan Hospital	Ann Arbor	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume change on spatially registered (aligned) images tracks path. response better than volume change on unregistered images.	Self explanatory.	2002-2014	No
Secondary	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.	2002-2014	No