Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072501
Status:
COMPLETED
Last Update Posted:
2012-10-30
First Post:
2003-11-04
Brief Title:
Breast Ultrasound and Mammography in Screening Women at High Risk for Breast Cancer
Sponsor:
American College of Radiology Imaging Network
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Screening Breast Ultrasound in High-Risk Women
Status:
COMPLETED
Status Verified Date:
2006-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Screening tests such as ultrasound and mammography may help doctors detect cancer cells early and plan more effective treatment for breast cancer It is not yet known whether ultrasound is more effective than mammography in detecting breast cancer
PURPOSE This clinical trial is studying breast ultrasound to see how well it works compared to mammography in detecting cancer in women who are at high risk for breast cancer
PURPOSE This clinical trial is studying breast ultrasound to see how well it works compared to mammography in detecting cancer in women who are at high risk for breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the diagnostic yield of whole breast bilateral screening ultrasound and mammography for the detection of breast cancer in women at high risk for breast cancer
Determine the cancer detection yield of a single contrast-enhanced magnetic resonance imaging MRI examination after 3 rounds of annual screening with ultrasound and mammography in these participants MRI component of the study
Secondary
Determine the independent sensitivity and specificity of these screening methods in these participants
Correlate performance of these screening methods with selected participant characteristics eg breast density and heterogeneity of the parenchyma
Validate the sonographic classification of lesions as probably benign and estimate the rate of malignancy in participants screened with these methods
Determine the cost effectiveness associated with screening breast ultrasound in terms of radiologist and resource time performing the exam and the induced cost of screening ultrasound eg follow-up and biopsy
Determine the reproducibility of lesion identification measurement of lesion diameters and volume and recording of lesion location on ultrasound in these participants
Determine the size type grade and nodal status of cancers seen only on MRI in these participants MRI component of the study
Estimate the rate of benign biopsies and short interval follow-up induced only by MRI in these participants MRI component of the study
Determine the cost effectiveness of MRI including induced costs of unnecessary biopsies and follow-up MRI component of the study
Compare the agreement among multiple examiners in sonographic mammographic and MRI feature analysis using terms from the BI-RADS lexicon and final assessment eg estimated probability of malignancy andor recommendation for biopsy in the enriched set of diagnostic training cases with consensus and histopathologic reference standards
OUTLINE This is a randomized multicenter study Participants are randomized to 1 of 2 screening arms
Arm I Participants undergo physician-performed bilateral whole breast ultrasound US followed by mammogram within 2 weeks
Arm II Participants undergo mammogram followed by physician-performed bilateral whole breast US within 2 weeks
In both arms participants with negative or benign findings are rescreened according to their screening arm at 1 and 2 years Participants with probably benign findings are rescreened at the 6-month follow-up visit Participants with findings that are suspicious or highly suggestive of malignancy are recommended for biopsy
A subset of participants in both arms undergo contrast-enhanced breast MRI within 4 weeks after completion of the 2-year screening US and mammogram Participants with probably benign findings seen only on MRI may undergo an additional breast MRI at the 6-month follow-up visit Participants with additional suspicious lesions seen only on MRI undergo second-look targeted US for biopsy guidance or MRI-guided vacuum-assisted biopsy after completion of any biopsies or additional views prompted by the 2-year screening US and mammogram visit
NOTE No diagnosis of metastatic cancer of any type since entering this clinical trial
Participants are followed annually for 3 years
PROJECTED ACCRUAL A total of 2808 participants will be accrued for this study within 2 years
Primary
Determine the diagnostic yield of whole breast bilateral screening ultrasound and mammography for the detection of breast cancer in women at high risk for breast cancer
Determine the cancer detection yield of a single contrast-enhanced magnetic resonance imaging MRI examination after 3 rounds of annual screening with ultrasound and mammography in these participants MRI component of the study
Secondary
Determine the independent sensitivity and specificity of these screening methods in these participants
Correlate performance of these screening methods with selected participant characteristics eg breast density and heterogeneity of the parenchyma
Validate the sonographic classification of lesions as probably benign and estimate the rate of malignancy in participants screened with these methods
Determine the cost effectiveness associated with screening breast ultrasound in terms of radiologist and resource time performing the exam and the induced cost of screening ultrasound eg follow-up and biopsy
Determine the reproducibility of lesion identification measurement of lesion diameters and volume and recording of lesion location on ultrasound in these participants
Determine the size type grade and nodal status of cancers seen only on MRI in these participants MRI component of the study
Estimate the rate of benign biopsies and short interval follow-up induced only by MRI in these participants MRI component of the study
Determine the cost effectiveness of MRI including induced costs of unnecessary biopsies and follow-up MRI component of the study
Compare the agreement among multiple examiners in sonographic mammographic and MRI feature analysis using terms from the BI-RADS lexicon and final assessment eg estimated probability of malignancy andor recommendation for biopsy in the enriched set of diagnostic training cases with consensus and histopathologic reference standards
OUTLINE This is a randomized multicenter study Participants are randomized to 1 of 2 screening arms
Arm I Participants undergo physician-performed bilateral whole breast ultrasound US followed by mammogram within 2 weeks
Arm II Participants undergo mammogram followed by physician-performed bilateral whole breast US within 2 weeks
In both arms participants with negative or benign findings are rescreened according to their screening arm at 1 and 2 years Participants with probably benign findings are rescreened at the 6-month follow-up visit Participants with findings that are suspicious or highly suggestive of malignancy are recommended for biopsy
A subset of participants in both arms undergo contrast-enhanced breast MRI within 4 weeks after completion of the 2-year screening US and mammogram Participants with probably benign findings seen only on MRI may undergo an additional breast MRI at the 6-month follow-up visit Participants with additional suspicious lesions seen only on MRI undergo second-look targeted US for biopsy guidance or MRI-guided vacuum-assisted biopsy after completion of any biopsies or additional views prompted by the 2-year screening US and mammogram visit
NOTE No diagnosis of metastatic cancer of any type since entering this clinical trial
Participants are followed annually for 3 years
PROJECTED ACCRUAL A total of 2808 participants will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ACRIN-6666 | None | None | None |