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

NCT02406274 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 249

Last updated 2024-06-28

No results posted yet for this study

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.

Conditions

  • Breast Abnormalities

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Maxine Jochelson, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2024-06-27
Completion
2024-06-27

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02406274 on ClinicalTrials.gov