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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Paul L. Carson Ph.D, University of Michigan
ClinicalTrials.gov Identifier:
NCT00721903
First received: July 23, 2008
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention
Breast Cancers
Procedure: Ultrasound Scan
Procedure: Mammography and Ultrasound

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 3D Breast Ultrasound In Predicting Response to Breast Cancer Therapies

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Volume change on spatially registered (aligned) images tracks path. response better than volume change on unregistered images. [ Time Frame: 2002-2014 ] [ Designated as safety issue: No ]
    Self explanatory.


Secondary Outcome Measures:
  • Spatially register pre, intra and post treatment ultrasound image volumes of treated tumor. [ Time Frame: 2002-2014 ] [ Designated as safety issue: No ]
    Visually measure separation between two corresponding points in two ultrasound image volumes after registration to verify registration accuracy.


Enrollment: 88
Study Start Date: March 2000
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Healthy Subjects
Healthy Subjects
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 match the age ranges of the patients with symptoms, initially 30 to 70 years of age.
Active Comparator: Cancer
120 women who have been diagnosed by biopsy to have breast cancer
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.

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.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721903

Locations
United States, Michigan
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Paul L. Carson, Ph.D. University of Michigan
Principal Investigator: Paul Carson, PhD University of Michigan
  More Information

No publications provided

Responsible Party: Paul L. Carson Ph.D, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT00721903     History of Changes
Other Study ID Numbers: 2001-0124, UMCC 0005
Study First Received: July 23, 2008
Last Updated: January 16, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 25, 2014