NCT00874458

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Apr 2007

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

4.1 years

First QC Date

April 1, 2009

Last Update Submit

April 29, 2026

Conditions

Breast Cancer

Keywords

ductal breast carcinoma in situ

Outcome Measures

Primary Outcomes (1)

  • Correlation of tumor extension by MRI with surgical histology

    up to 1 year

Study Arms (1)

MRI

EXPERIMENTAL
Procedure: magnetic resonance imagingProcedure: radiomammographyProcedure: ultrasound imaging

Interventions

magnetic resonance imagingPROCEDURE
MRI
radiomammographyPROCEDURE
MRI
ultrasound imagingPROCEDURE
MRI

Eligibility Criteria

Age18 Years - 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Centre Antoine Lacassagne

Nice, 06189, France

Location

Related Publications (1)

  • 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.

    PMID: 19896789RESULT

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma, Intraductal, Noninfiltrating

Interventions

Magnetic Resonance SpectroscopyHigh-Energy Shock Waves

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeBreast Carcinoma In SituCarcinoma in SituNeoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesUltrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Claire Chapellier

    Centre Antoine Lacassagne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2009

First Posted

April 2, 2009

Study Start

April 1, 2007

Primary Completion

May 1, 2011

Study Completion

December 1, 2013

Last Updated

May 5, 2026

Record last verified: 2026-04

Locations

FR(1)