Breast MRI as a Preoperative Tool for DCIS

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00605982
First received: January 21, 2008
Last updated: January 31, 2014
Last verified: January 2014

January 21, 2008
January 31, 2014
October 2006
October 2014   (final data collection date for primary outcome measure)
To prospectively evaluate the value of preoperative breast MRI in women with core biopsy-proven DCIS. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00605982 on ClinicalTrials.gov Archive Site
  • To determine the proportion of all patients in this study in whom breast MRI identifies at least one site of cancer separate from the index lesion. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
  • To estimate re-excision rates and mastectomy rates in patients with DCIS undergoing preoperative MRI. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
  • To estimate the proportion of patients with DCIS in which preoperative MRI will change surgical planning. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
  • To estimate the long-term ipsilateral breast recurrence rate in women with DCIS undergoing preoperative breast MRI. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Breast MRI as a Preoperative Tool for DCIS
Breast MRI as a Preoperative Tool for DCIS

Breast MRI is a fairly new technology, but it has been well studied. It is now used routinely in many patients with breast cancer. It has been shown to be useful in detecting areas of cancer that cannot be seen using other types of scans or tests.

The purpose of this study is to see how often MRI can find other areas of cancer in women with one area of breast cancer, and to determine how having the MRI test affects their treatment. The purpose is also to study any areas of abnormality seen on your MRI with special methods that allow the images of your breast tissue and the microscopic analysis of your breast tissue to be compared very carefully. The study also aims to follow women who enter the study over a 10-year period to determine how often the breast cancer comes back.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Breast Cancer
  • Ductal Carcinoma in Situ
Procedure: MRI
The patient will then undergo a breast MRI as part of their preoperative work-up of DCIS. Biopsy of any suspicious areas by needle biopsy or at the time of surgery. If appropriate, repeat MRI after biopsy or surgery. Follow-up for 10 years (you will be contacted once a year to see how you are doing).
Experimental: 1
Women with core biopsy proven DCIS with or without microinvasion seen for surgical consultation at Memorial Sloan-Kettering Cancer Center and for whom operative intervention is planned.
Intervention: Procedure: MRI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
115
October 2014
October 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age less than 60 at time of consent
  • Clinical stage is consistent with Stage 0 or Stage I T1mic at presentation
  • Core biopsy proven DCIS or DCIS with microinvasion (invasion ≤0.1 cm), prior to enrollment
  • Breast surgery to be performed at MSKCC
  • Informed consent obtained
  • Female

Exclusion Criteria:

  • Age 60 or over at time of consent
  • Patients who are pregnant or nursing
  • Patients with contraindications to breast conservation
  • Excisional biopsy of DCIS or DCIS with microinvasion, prior to enrollment
  • Patients with any contraindications to MRI including pacemaker, tissue expander, other metallic surgical implants, weight over 350 lb., previous gadolinium reaction, metal fragments in eye
Both
21 Years to 59 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00605982
06-124
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Kimberly Van Zee, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP