Use of Contrast Enhanced Spectral Mammography (CESM) for Women With Palpable Breast Abnormalities
Primary Purpose
Breast Abnormalities
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Contrast Enhanced Spectral Mammography (CESM)
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Abnormalities focused on measuring Mammography, Contrast Enhanced Spectral Mammography, Palpable Breast Abnormalities, 15-053
Eligibility Criteria
Inclusion Criteria:
- Women presenting for mammographic evaluation of an undiagnosed palpable mass found either by self examination and/or examination by referring physician
Exclusion Criteria:
- Age < 25 years old
- Male patients
- Pregnant or lactating patients
- Patients with allergy to iodinated contrast
- Patients with a history of renal disease or patients over 70 with a creatinine > 1.3. Creatinine must have been done within the last 12 weeks.
Sites / Locations
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Contrast Enhanced Spectral Mammography
Arm Description
Outcomes
Primary Outcome Measures
positive predictive value
(PPV) will be defined using three distinct definitions: (1) PPV1 is the proportion of women with a positive assessment who had a cancer diagnosis in the follow-up period. (2) PPV2 is the proportion of women with a recommendation for biopsy who had a cancer diagnosis in the follow-up period. (3) PPV3 is the proportion of women with a biopsy recommendation and a biopsy performed within 1 year who had a cancer diagnosis in the follow-up period. Negative predictive value (NPV) is the proportion of women with a negative assessment who did not have a cancer diagnosis.
Secondary Outcome Measures
Full Information
NCT ID
NCT02406274
First Posted
March 30, 2015
Last Updated
April 3, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT02406274
Brief Title
Use of Contrast Enhanced Spectral Mammography (CESM) for Women With Palpable Breast Abnormalities
Official Title
Use of Contrast Enhanced Spectral Mammography (CESM) for Women With Palpable Breast Abnormalities
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2015 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
4. Oversight
5. Study Description
Brief Summary
Contrast Enhanced Spectral Mammography (CESM) is an advanced form of mammography which is performed after injection of contrast or dye into a vein in the arm. This dye is the same dye that is used for CT scans. This type of mammogram includes a regular mammogram as well as additional pictures with the dye.
This particular study is being done to determine if by adding the dye in the veins the investigators are better able to identify the cause of the lump than if they just did the regular mammogram alone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Abnormalities
Keywords
Mammography, Contrast Enhanced Spectral Mammography, Palpable Breast Abnormalities, 15-053
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
249 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Contrast Enhanced Spectral Mammography
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Contrast Enhanced Spectral Mammography (CESM)
Intervention Description
Women presenting to MSKCC with a palpable abnormality within the breast either self palpated & or palpated by their physician will be offered CESM instead of FFDM alone. The breast imager assigned to care for the patient will interpret the low energy images (including any additional views they routinely obtain) & record their findings. They will then interpret the CESM & record those results. As per standard of care, the patient will have a targeted ultrasound as well. Appropriate clinical recommendations will be made. In patients with no specific imaging findings, follow-up will be determined by the degree of suspicion of the palpable finding & will either be called negative & followed clinically if not suspicious, or will go on to MRI , percutaneous biopsy by a surgeon or surgical biopsy if suspicious.
Primary Outcome Measure Information:
Title
positive predictive value
Description
(PPV) will be defined using three distinct definitions: (1) PPV1 is the proportion of women with a positive assessment who had a cancer diagnosis in the follow-up period. (2) PPV2 is the proportion of women with a recommendation for biopsy who had a cancer diagnosis in the follow-up period. (3) PPV3 is the proportion of women with a biopsy recommendation and a biopsy performed within 1 year who had a cancer diagnosis in the follow-up period. Negative predictive value (NPV) is the proportion of women with a negative assessment who did not have a cancer diagnosis.
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women presenting for mammographic evaluation of an undiagnosed palpable mass found either by self examination and/or examination by referring physician
Exclusion Criteria:
Age < 25 years old
Male patients
Pregnant or lactating patients
Patients with allergy to iodinated contrast
Patients with a history of renal disease or patients over 70 with a creatinine > 1.3. Creatinine must have been done within the last 12 weeks.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maxine Jochelson, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center
Learn more about this trial
Use of Contrast Enhanced Spectral Mammography (CESM) for Women With Palpable Breast Abnormalities
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