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

Breast Abnormalities Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02406274
• Other study ID #: 15-053
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 2015
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 249
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Abnormalities
• Congenital Abnormalities

Intervention

Other:
• Contrast Enhanced Spectral Mammography (CESM)
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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year

External Links

•   Memorial Sloan Kettering Cancer Center