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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-03-31

Study Completion Date

2014-09-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Breast Cancers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Healthy Subjects

Ultrasound scan

Group Type ACTIVE_COMPARATOR

Ultrasound Scan

Intervention Type PROCEDURE

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.

Cancer

120 women diagnosed by biopsy to have breast cancer will have an ultrasound scan

Group Type ACTIVE_COMPARATOR

Mammography and Ultrasound

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes