Chemotherapy Monitoring With Breast Computed Tomography (CT)

Breast Cancer Clinical Trial

Official title:

Breast Cancer Chemotherapy Monitoring With Dedicated Breast Computed Tomography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00808041
• Other study ID #: IRB00012068
• Secondary ID: 1P50CA128301-01A
• Status: Completed
• Phase: N/A
• First received: December 12, 2008
• Last updated: July 21, 2015
• Start date: July 2009
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: July 2015
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• Dedicated breast computed tomography imaging
Pre- and post-contrast enhancement acquisition of breast CT images of tumor-containing breast every two months.

Locations

Country	Name	City	State
United States	Emory University Winship Cancer Institute	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor response		Mid-treatment and post-treatment completion	No