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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00605982
Other study ID # 06-124
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 10, 2006
Est. completion date October 2024

Study information

Verified date April 2024
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 115
Est. completion date October 2024
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group 21 Years to 59 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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).

Locations

Country Name City State
United States Memorial Sloan Kettering Cancer Center Basking Ridge New Jersey
United States Memorial Sloan Kettering Cancer Center Commack New York
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To prospectively evaluate the value of preoperative breast MRI in women with core biopsy-proven DCIS. conclusion of the study
Secondary 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. conclusion of the study
Secondary To estimate re-excision rates and mastectomy rates in patients with DCIS undergoing preoperative MRI. conclusion of the study
Secondary To estimate the proportion of patients with DCIS in which preoperative MRI will change surgical planning. conclusion of the study
Secondary To estimate the long-term ipsilateral breast recurrence rate in women with DCIS undergoing preoperative breast MRI. conclusion of the study
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