|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 24, 2008 | ||||
| Last Updated Date | May 20, 2009 | ||||
| Start Date ICMJE | January 2008 | ||||
| Estimated Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To learn how often magnetic resonance imaging (MRI) of the breast locates additional areas of cancer in the breast of patients with lobular cancer. [ Time Frame: 3 Years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
The goal of this clinical research study is to learn how often magnetic resonance imaging (MRI) of the breast locates additional areas of cancer in the breast of patients with lobular cancer. [ Time Frame: 3 Years ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00610181 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
To learn how often the results of the MRI changes the type of surgery that is recommended. [ Time Frame: 3 Years ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Magnetic Resonance Imaging in Patients With Breast Cancer | ||||
| Official Title ICMJE | Magnetic Resonance Imaging (MRI) for Preoperative Staging of Patients With Invasive Lobular Carcinoma of the Breast | ||||
| Brief Summary | Objectives:
|
||||
| Detailed Description | At M. D. Anderson, patients with breast cancer routinely have mammograms and ultrasounds to measure the size and extent of cancer. MRI of the breast is a technology that is better than mammograms and ultrasounds at locating cancer. Although MRI may locate more areas of cancer, it can sometimes falsely identify normal areas of the breast as cancerous. Unlike ductal cancer of the breast (the most common type of breast cancer), lobular cancer is more difficult to see on mammograms and ultrasounds. Therefore, patients with lobular cancer of the breast may be best suited for MRI of the breast in order to more accurately determine the extent of the cancer. In addition, in young women, because the breast tissue is very dense, all types of breast tumors are harder to detect with mammogram and ultrasound and may be better seen with MRI. A correct measurement of the size and extent of the cancer is important because this affects the recommendation for the type of surgery a patient may have. Study Procedures: If you agree to take part in this study, you will have an MRI of both breasts. For the MRI, part or all of the body will be passed into a long, narrow tube scanner, which is open at both ends. The MRI images will be compared with the images from your standard of care mammogram and ultrasound images. If the MRI shows abnormalities not seen on the mammogram or ultrasound and your doctor thinks it is necessary, you may have additional testing and/or a tumor biopsy. This is part of your standard of care. The results of this additional MRI testing will be used by your surgeon to guide his/her recommendations for your surgery. MRI will be repeated in 1 year as part of your routine follow-up after surgery. This is an investigational study. The investigational part of this study is the comparison of the outcome of MRI images to mammogram and ultrasound images in determining appropriate surgical therapy. Up to 150 patients will be take part in this study. All will be enrolled at M. D. Anderson. |
||||
| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Case-Only, Prospective | ||||
| Condition ICMJE | Breast Cancer | ||||
| Intervention ICMJE | Procedure: Magnetic Resonance Imaging | ||||
| Study Arms / Comparison Groups | Patients with invasive lobular carcinoma of the breast. | ||||
| Publications * | |||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 150 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
|
||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00610181 | ||||
| Responsible Party | Isabelle Bedrosian, MD/Assistant Professor, U.T.M.D. Anderson Cancer Center | ||||
| Study ID Numbers ICMJE | 2007-0736 | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
|
||||
| Information Provided By | M.D. Anderson Cancer Center | ||||
| Verification Date | May 2009 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||