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Breast MRI as a Preoperative Tool for DCIS

Primary Purpose

Breast Cancer, Ductal Carcinoma in Situ

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring MRI

Eligibility Criteria

21 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
To estimate re-excision rates and mastectomy rates in patients with DCIS undergoing preoperative MRI.
To estimate the proportion of patients with DCIS in which preoperative MRI will change surgical planning.
To estimate the long-term ipsilateral breast recurrence rate in women with DCIS undergoing preoperative breast MRI.

Full Information

First Posted
January 21, 2008
Last Updated
April 18, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00605982
Brief Title
Breast MRI as a Preoperative Tool for DCIS
Official Title
Breast MRI as a Preoperative Tool for DCIS
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 10, 2006 (undefined)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Ductal Carcinoma in Situ
Keywords
MRI

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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 Type
Procedure
Intervention Name(s)
MRI
Intervention Description
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 Outcome Measure Information:
Title
To prospectively evaluate the value of preoperative breast MRI in women with core biopsy-proven DCIS.
Time Frame
conclusion of the study
Secondary Outcome Measure Information:
Title
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
Title
To estimate re-excision rates and mastectomy rates in patients with DCIS undergoing preoperative MRI.
Time Frame
conclusion of the study
Title
To estimate the proportion of patients with DCIS in which preoperative MRI will change surgical planning.
Time Frame
conclusion of the study
Title
To estimate the long-term ipsilateral breast recurrence rate in women with DCIS undergoing preoperative breast MRI.
Time Frame
conclusion of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly Van Zee, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
Basking Ridge
State/Province
New Jersey
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

Breast MRI as a Preoperative Tool for DCIS

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