MRI in Assessing Tumor Size in Women With Ductal Carcinoma In Situ

April 29, 2026 updated by: Centre Antoine Lacassagne

Ductal Carcinoma in Situ: Protocol Evaluating the Assessment of Extension of Disease by MRI

RATIONALE: Diagnostic procedures, such as MRI, may help find ductal carcinoma in situ and find out how far the disease has spread.

PURPOSE: This clinical trial is studying how well MRI works in assessing tumor size in women with ductal carcinoma in situ.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Assess the contribution of MRI in accurately determining tumor size in women with ductal breast carcinoma in situ (DCIS).

Secondary

  • Evaluate the sensitivity of MRI in detecting DCIS.
  • Evaluate the contribution of mammography in accurately determining tumor size.
  • Compare the contribution of MRI vs mammography in assessing tumor extension.
  • Compare the contribution of MRI vs mammography in assessing dense breasts.
  • Evaluate the morphology of DCIS by MRI.
  • Evaluate the curve of dynamic MRI in assessing DCIS.
  • Evaluate the impact of nuclear grade of DCIS by MRI.
  • Evaluate the rate of revision surgery.

OUTLINE: Patients undergo clinical examination, mammography, ultrasound imaging, unilateral breast MRI, and tissue sampling.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nice, France, 06189
        • Centre Antoine Lacassagne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

DISEASE CHARACTERISTICS:

  • Diagnosis of ductal breast carcinoma in situ

    • Any grade disease allowed
  • Unifocal disease by mammography
  • No history of breast cancer
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Menopausal status not specified
  • WHO performance status 0-2
  • Glomerular filtration rate ≥ 30 mL/min
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No allergy or contraindication to contrast MRI
  • No pacemaker or vascular clip

PRIOR CONCURRENT THERAPY:

  • No prior or concurrent liver transplantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MRI
Procedure: magnetic resonance imaging
Procedure: ultrasound imaging
Procedure: radiomammography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlation of tumor extension by MRI with surgical histology
Time Frame: up to 1 year
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Antoine Lacassagne

Investigators

  • Principal Investigator: Claire Chapellier, Centre Antoine Lacassagne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

April 1, 2009

First Submitted That Met QC Criteria

April 1, 2009

First Posted (Estimated)

April 2, 2009

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006/25
  • CALACASS-CCIS
  • CALACASS-2006/25
  • INCA-RECF0620
  • 2006-A00251-50 (Other Identifier: AFSSAPS ID RCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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