Chemotherapy Monitoring With Breast Computed Tomography (CT) - Full Text View

Sponsored by:	Emory University
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00808041

Purpose

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	Intervention
Breast Cancer	Device: Dedicated breast computed tomography imaging

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer CT Scans Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Retrospective
Official Title:	Breast Cancer Chemotherapy Monitoring With Dedicated Breast Computed Tomography

Further study details as provided by Emory University:

Primary Outcome Measures:

Tumor response [ Time Frame: Sep '09 to Sep '10 ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	10
Study Start Date:	January 2009
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders 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.

Criteria

Inclusion Criteria:

All subjects will be women at least 18 years of age that will undergo pre-operative hormonal therapy for breast cancer before lumpectomy or mastectomy.
Women who will participate in the clinical trial titled "Randomized phase II trial of pre-operative docetaxel-cytoxan (TC) or exemestane in patients with hormone receptor-positive breast cancers with recurrence scores less than 25 (≤24)" (P.I.: Ruth O'Regan, M.D.) at Emory University and are placed in Arm A of this trial.
Women who have undergone pre treatment breast MR imaging to verify that no additional findings are present.

Exclusion 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808041

Contacts

Contact: Ellen M D'Orsi, RT (R)(M)	404-778-3009	ellen.dorsi@emoryhealthcare.org
Contact: Ioannis Sechopoulos, PhD	404-712-2412	isechop@emory.edu

Locations

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

Sponsors and Collaborators

Emory University

Investigators

Principal Investigator:

Ioannis Sechopoulos, PhD

Emory University

More Information

Responsible Party:	Emory University ( Ioannis Sechopoulos. PhD )
Study ID Numbers:	12068, 1P50CA128301-01A1
Study First Received:	December 12, 2008
Last Updated:	December 12, 2008
ClinicalTrials.gov Identifier:	NCT00808041
Health Authority:	United States: Institutional Review Board

Keywords provided by Emory University:

Neoadjuvant Treatment
Therapy Response
Breast Computed Tomography

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009