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Completed

NCT Number: NCT00808041

Chemotherapy Monitoring With Breast Computed Tomography (CT)

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dedicated breast computed tomography imaging

Device

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

Primary outcomes

  1. Tumor response

    Time frame: Mid-treatment and post-treatment completion

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

Breast Cancer Chemotherapy Monitoring With Dedicated Breast Computed Tomography

Important dates

Study start
2009
Primary completion
2012
Study completion
2015
First posted
Dec 15, 2008
Registry last updated
Jul 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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