Use of Contrast Enhanced Spectral Mammography (CESM) for Women With Palpable Breast Abnormalities

Not Applicable

Completed

• Conditions: Breast Abnormalities
• Interventions: Other: Contrast Enhanced Spectral Mammography (CESM)

• Registration Number: NCT02406274
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-30
• Study First Submitted QC: 2015-04-01
• Study First Posted: 2015-04-02
• Status Verified: 2024-06
• Primary Completion: 2024-06-27
• Study Completion: 2024-06-27
• Last Update Submitted: 2024-06-27
• Last Update Posted: 2024-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 249

Inclusion Criteria

• Women presenting for mammographic evaluation of an undiagnosed palpable mass found either by self examination and/or examination by referring physician

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Contrast Enhanced Spectral Mammography	Contrast Enhanced Spectral Mammography (CESM)	-

Primary Outcome Measures

Name	Time	Method
positive predictive value	1 year	(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.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States