Breast CancerNCT00874458
MRI in Assessing Tumor Size in Women With Ductal Carcinoma In Situ
A study testing magnetic resonance imaging, radiomammography and ultrasound imaging in people with Breast Cancer, run by Centre Antoine Lacassagne at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- magnetic resonance imaging, radiomammography and ultrasound imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2007to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- magnetic resonance imaging, radiomammography, ultrasound imaging
- Keywords
- ductal breast carcinoma in situ
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance imagingProcedure or surgery
radiomammographyProcedure or surgery
ultrasound imagingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| MRI | Experimental | Not described Receives: Procedure: magnetic resonance imaging; Procedure: radiomammography; Procedure: ultrasound imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of tumor extension by MRI with surgical histology
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2009 (estimated)
- Study startApr 2007
- Primary completionMay 2011
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Antoine Lacassagne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire Chapellier, Principal investigator, Centre Antoine Lacassagne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00874458
- Sponsor's protocol ID
- 2006/25
- Other IDs
- CALACASS-CCIS, CALACASS-2006/25, 2006-A00251-50, INCA-RECF0620
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2009
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Marcotte-Bloch C, Balu-Maestro C, Chamorey E, Ettore F, Raoust I, Flipo B, Chapellier C. MRI for the size assessment of pure ductal carcinoma in situ (DCIS): a prospective study of 33 patients. Eur J Radiol. 2011 Mar;77(3):462-7. doi: 10.1016/j.ejrad.2009.09.003. Epub 2009 Nov 6.
PubMed 19896789
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ductal Carcinoma in Situ: Protocol Evaluating the Assessment of Extension of Disease by MRI
- ClinicalTrials.gov ID
- NCT00874458
- Acronym / sponsor ID
- 2006/25
- Conditions
- Breast Cancer
- Keywords
- ductal breast carcinoma in situ
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Antoine LacassagneUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- May 2011 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 2 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI | Experimental | Procedure: magnetic resonance imaging, Procedure: radiomammography, Procedure: ultrasound imaging |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| magnetic resonance imaging | Procedure or surgery | MRI |
| radiomammography | Procedure or surgery | MRI |
| ultrasound imaging | Procedure or surgery | MRI |
Primary outcome
Correlation of tumor extension by MRI with surgical histology
Time frame: up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Results publication: PubMed 19896789Marcotte-Bloch C, Balu-Maestro C, Chamorey E, Ettore F, Raoust I, Flipo B, Chapellier C. MRI for the size assessment of pure ductal carcinoma in situ (DCIS): a prospective study of 33 patients. Eur J Radiol. 2011 Mar;77(3):462-7. doi: 10.1016/j.ejrad.2009.09.003. Epub 2009 Nov 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire Chapellier principal investigator
Centre Antoine Lacassagne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing magnetic resonance imaging, radiomammography and ultrasound imaging in people with Breast Cancer, run by Centre Antoine Lacassagne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of tumor extension by MRI with surgical histology (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00874458, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.