Chemotherapy Monitoring With Breast Computed Tomography (CT)

NCT ID: NCT00808041

Last Updated: 2015-07-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2015-07-31

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.

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Treatment

Breast cancer patients undergoing hormonal therapy before surgery.

Dedicated breast computed tomography imaging

Intervention Type: DEVICE

Pre- and post-contrast enhancement acquisition of breast CT images of tumor-containing breast every two months.

Interventions

Dedicated breast computed tomography imaging

Pre- and post-contrast enhancement acquisition of breast CT images of tumor-containing breast every two months.

Intervention Type: DEVICE

Other Intervention Names

Koning CBCT,Cone Beam Breast CT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Ioannis Sechopoulos, Ph.D.

Assistant Professor of Radiology and Imaging Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ioannis Sechopoulos, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University Winship Cancer Institute

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

1P50CA128301-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00012068

Identifier Type: -

Identifier Source: org_study_id