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

3D Breast Ultrasound In Predicting Response to Breast Cancer Therapies

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00721903

Enrollment

Registered

2008-07-25

Start date

2000-03-31

Completion date

2014-09-30

Last updated

2016-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancers

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.

Interventions

PROCEDUREUltrasound 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.

PROCEDUREMammography 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

25 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026