Chemotherapy Monitoring With Breast Computed Tomography (CT)

Breast Cancer Chemotherapy Monitoring With Dedicated Breast Computed Tomography

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: 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
• Enrollment (Actual): 3

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Winship Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 Names: Koning CBCT,Cone Beam Breast CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Tumor response	Mid-treatment and post-treatment completion

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Ioannis Sechopoulos, PhD, Emory University

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: December 12, 2008
• First Submitted That Met QC Criteria: December 12, 2008
• First Posted (Estimate): December 15, 2008

Study Record Updates

• Last Update Posted (Estimate): July 23, 2015
• Last Update Submitted That Met QC Criteria: July 21, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Neoadjuvant Treatment; Therapy Response; Breast Computed Tomography
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: IRB00012068; 1P50CA128301-01A1 (U.S. NIH Grant/Contract)