Trial record 6 of 62 for:
Open Studies | mammography
Comparison of Contrast Enhanced Mammography to Breast MRI in Screening Patients at Increased Risk for Breast Cancer
This study is currently recruiting participants.
Verified November 2012 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Memorial Sloan-Kettering Cancer Center
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01716247
First received: October 25, 2012
Last updated: November 28, 2012
Last verified: November 2012
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Purpose
The purpose of this study is to determine if Contrast Enhanced Spectral Mammography (CESM) will be able to detect smaller/earlier breast cancers as well as breast MRI can.
| Condition | Intervention |
|---|---|
|
Women at Increased Risk for Developing Breast Carcinoma |
Other: Mammography (CESM) and MRI |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Diagnostic |
| Official Title: | Comparison of Contrast Enhanced Mammography to Breast MRI in Screening Patients at Increased Risk for Breast Cancer |
Resource links provided by NLM:
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
Primary Outcome Measures:
- compare the sensitivity and specificity CESM [ Time Frame: 1 year ] [ Designated as safety issue: No ]CESM to that of breast MRI in a population of women who are being screened because they are at increased risk for developing breast cancer. For this purpose a positive CESM test will be defined as a score of 4 or 5. We will use the existing MRI BIRADS system to score CESM images based on the characteristics of individual lesions and increased enhancement compared to the background. A positive MRI test will be defined by a BIRADs score of 4 or 5.
| Estimated Enrollment: | 1000 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: pts at risk for breast cancer
Women at increased risk for breast cancer who are being referred for screening MRI will be offered and consented for CESM at the same time. The 2 examinations will be performed on the same day when at all possible and if not we will make every attempt to perform CESM before MRI. Patients with outside MRI performed within 30 days and of adequate quality will also be eligible for CESM.
|
Other: Mammography (CESM) and MRI
The study consists of the addition of a single contrast enhanced digital mammography examination (CESM) to the routine screening of a woman at increased risk for breast cancer who is also having a breast MRI. Breast MRIs will be read by the radiologist reading breast MRIs on any given day. CESM is a dedicated system, derived from a standard digital mammography unit modified to deliver the dual or multiple energy exposures and visualization of combined images after IV contrast administration. Patients will be randomly assigned to one of the radiologists trained to interpret CESM. That radiologist will read the CESM blinded to the results of the breast MRI.This process will be monitored by the research assistant No radiologist will read both the breast MRI and CESM on the same patient. |
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Women considered at increased risk for developing breast carcinoma (those with a lifetime risk of >15%due to family history, genetic predisposition, prior radiation therapy to the chest, prior biopsy showing a high risk lesion, or personal history of breast cancer) that are being screened with breast MRI.
- Women who have a screening digital mammogram within the prior 365 days (including the current day and day of mammogram).
Exclusion Criteria:
- Women under 21.
- Pregnant or possibly pregnant.
- Women who have a contraindication to the intravenous use of iodinated or gadolinium-chelated contrast agent (i.e., allergy to either agent or severely impaired renal function with a creatinine level > or = to 1.3).
- Women with breast implants.
- Women with pacemakers.
- Women with aneurysm clips that don't allow for MRI.
- Women too claustrophobic to undergo MRI.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01716247
Contacts
| Contact: Maxine Jochelson, MD | 646-888-4507 | |
| Contact: David Dershaw, MD | 646-888-4505 |
Locations
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Maxine Jochelson, MD 646-888-4507 | |
| Contact: David Dershaw, MD 646-888-4505 | |
| Principal Investigator: Maxine Jochelson, MD | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
| Principal Investigator: | Maxine Jochelson, MD | Memorial Sloan-Kettering Cancer Center |
More Information
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01716247 History of Changes |
| Other Study ID Numbers: | 12-214 |
| Study First Received: | October 25, 2012 |
| Last Updated: | November 28, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
Mammography (CESM) MRI Breast screening 12-214 |
Additional relevant MeSH terms:
|
Breast Neoplasms Carcinoma Neoplasms by Site Neoplasms |
Breast Diseases Skin Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 16, 2013