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

University of Michigan

Status: Completed

Conditions: Breast Cancers

Treatments: Procedure: Mammography and Ultrasound; Procedure: Ultrasound Scan

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00721903

P01CA087634 (U.S. NIH Grant/Contract)

UMCC 0005 (Other Identifier)

2001-0124

Details and patient eligibility

About

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

Full 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.

Enrollment: 88 patients

Sex: Female

Ages: 25+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

Healthy Subjects

Active Comparator group

Description:

Ultrasound scan

Treatment:

Procedure: Ultrasound Scan

Cancer

Active Comparator group

Description:

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

Treatment:

Procedure: Mammography and Ultrasound