Chemotherapy Monitoring With Breast Computed Tomography (CT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00808041
Recruitment Status : Completed
First Posted : December 15, 2008
Last Update Posted : July 23, 2015
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Ioannis Sechopoulos, Ph.D., Emory University

Brief Summary:
The purpose of this study is to determine if dedicated breast computed tomography can be used successfully to monitor tumor response in breast cancer patients undergoing neoadjuvant chemotherapy.

Condition or disease Intervention/treatment
Breast Cancer Device: Dedicated breast computed tomography imaging

Detailed Description:

Before undergoing surgery to remove the tumor, it is common for breast cancer patients to first undergo chemotherapy or hormonal therapy. The main goal of the therapy is to reduce the size of the tumor before it is removed. Unfortunately, therapy response varies a lot between patients. The development of an effective therapy response monitoring method could reduce the time that a patient undergoes ineffectual therapy or unnecessary therapy after complete response.

Dedicated breast computed tomography (or breast CT), a new way of imaging the breast, has been introduced in the last few years. Breast CT is an x-ray exam that uses 3D imaging to show the breast in its real three dimensional shape. Combined with the use of special chemicals called iodine contrast enhancement, breast CT can provide images of both the anatomy and the blood flow in the breast. We propose to use breast CT to carefully monitor the response to therapy of breast cancer patients undergoing therapy before surgery.

Study Type : Observational
Actual Enrollment : 3 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Breast Cancer Chemotherapy Monitoring With Dedicated Breast Computed Tomography
Study Start Date : July 2009
Actual Primary Completion Date : September 2012
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Breast cancer patients undergoing hormonal therapy before surgery.
Device: Dedicated breast computed tomography imaging
Pre- and post-contrast enhancement acquisition of breast CT images of tumor-containing breast every two months.
Other Name: Koning CBCT,Cone Beam Breast CT

Primary Outcome Measures :
  1. Tumor response [ Time Frame: Mid-treatment and post-treatment completion ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The target population for this study is women who will undergo pre-operative hormonal therapy for breast cancer before lumpectomy or mastectomy.

3.1 Eligibility Criteria

  • All subjects will be women at least 18 years of age that will undergo standard or research pre-operative hormonal therapy for breast cancer before lumpectomy or mastectomy.
  • Women who have undergone pre treatment breast MR imaging to verify that no additional findings are present.

3.2 Ineligibility Criteria

  • Subject does not meet any of the inclusion criteria
  • Women with suspected or confirmed pregnancy
  • Women who have had bilateral mastectomy
  • Women who are unable to remain in a prone position on the BCT system for the required amount of time
  • Women who cannot give informed consent
  • Women with metastasis
  • Male subjects
  • Women with implants
  • Women with breast augmentation, except for unilateral augmentation done for prior mastectomy
  • Women who are allergic to iodine
  • Women with physical limitations such as, but not limited to: frozen shoulder, recent heart surgery, pace maker, neck problems or any other condition that would prohibit them from lying face down
  • Women who have had problems or reactions to contrast, such as nausea/vomiting, itching, hives, B/P changes, respirator distress, cardiac arrest.
  • Women with history of Diabetes, kidney disease, kidney surgery, dialysis, heart disease-such as Congestive Heart Failure, Multiple Myeloma, Sickle Cell Anemia, Lupus, Rheumatoid Arthritis or other Autoimmune disease, recent surgery, chemotherapy, dehydration, high use of NSAIDs such as Ibuprofen

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00808041

United States, Georgia
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
National Institutes of Health (NIH)
Principal Investigator: Ioannis Sechopoulos, PhD Emory University

Responsible Party: Ioannis Sechopoulos, Ph.D., Assistant Professor of Radiology and Imaging Sciences, Emory University Identifier: NCT00808041     History of Changes
Other Study ID Numbers: IRB00012068
1P50CA128301-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 15, 2008    Key Record Dates
Last Update Posted: July 23, 2015
Last Verified: July 2015

Keywords provided by Ioannis Sechopoulos, Ph.D., Emory University:
Neoadjuvant Treatment
Therapy Response
Breast Computed Tomography

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