MRI in Assessing Tumor Size in Women With Ductal Carcinoma In Situ
This study has been completed.
Sponsor:
Centre Antoine Lacassagne
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00874458
First received: April 1, 2009
Last updated: May 12, 2011
Last verified: July 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Procedure: magnetic resonance imaging Procedure: radiomammography Procedure: ultrasound imaging |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Ductal Carcinoma in Situ: Protocol Evaluating the Assessment of Extension of Disease by MRI |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Correlation of tumor extension by MRI with surgical histology [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | April 2007 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00874458 History of Changes |
| Other Study ID Numbers: | CDR0000633336, CALACASS-CCIS, CALACASS-2006/25, CALACASS-ID-RCB-2006-A00251-50, INCA-RECF0620 |
| Study First Received: | April 1, 2009 |
| Last Updated: | May 12, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
ductal breast carcinoma in situ |
Additional relevant MeSH terms:
|
Breast Neoplasms Carcinoma Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Carcinoma, Ductal, Breast Carcinoma, Ductal Neoplasms by Site |
Neoplasms Breast Diseases Skin Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Adenocarcinoma Neoplasms, Ductal, Lobular, and Medullary |
ClinicalTrials.gov processed this record on May 19, 2013