Chemotherapy Monitoring With Breast Computed Tomography (CT)

NCT00808041 | Completed

• 2 other identifiers: IRB000120681P50CA128301-01A1
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Neoadjuvant Treatment; Therapy Response; Breast Computed Tomography

Outcome Measures

Primary Outcomes (1)

• Tumor response

  Mid-treatment and post-treatment completion

Study Arms (1)

Treatment

Breast cancer patients undergoing hormonal therapy before surgery.

Device: Dedicated breast computed tomography imaging

Interventions

Dedicated breast computed tomography imaging DEVICE

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

Also known as: Koning CBCT,Cone Beam Breast CT

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ioannis Sechopoulos, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Radiology and Imaging Sciences

Study Record Dates

• First Submitted: December 12, 2008
• First Posted: December 15, 2008
• Study Start: July 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: July 1, 2015
• Last Updated: July 23, 2015

Record last verified: 2015-07

Locations

US (1)