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Completed

NCT Number: NCT00605982

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.

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Key information

Conditions

Breast Cancer Adenocarcinoma Breast Carcinoma In Situ Breast Diseases Breast Neoplasms Carcinoma Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Ductal Carcinoma in Situ Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases

Age range

21 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering Cancer Center, Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

MRI

Procedure

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).

Primary outcomes

  1. To prospectively evaluate the value of preoperative breast MRI in women with core biopsy-proven DCIS.

    Time frame: conclusion of the study

Secondary outcomes

  1. 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

  2. To estimate re-excision rates and mastectomy rates in patients with DCIS undergoing preoperative MRI.

    Time frame: conclusion of the study

  3. To estimate the proportion of patients with DCIS in which preoperative MRI will change surgical planning.

    Time frame: conclusion of the study

  4. To estimate the long-term ipsilateral breast recurrence rate in women with DCIS undergoing preoperative breast MRI.

    Time frame: conclusion of the study

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start
2006
Primary completion
2025
Study completion
2025
First posted
Feb 1, 2008
Registry last updated
Apr 6, 2025

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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