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

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ClinicalTrials.gov Identifier: NCT02406274
Recruitment Status : Active, not recruiting
First Posted : April 2, 2015
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Breast Abnormalities Other: Contrast Enhanced Spectral Mammography (CESM) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 249 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Use of Contrast Enhanced Spectral Mammography (CESM) for Women With Palpable Breast Abnormalities
Actual Study Start Date : March 2015
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mammography

Arm Intervention/treatment
Experimental: Contrast Enhanced Spectral Mammography 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.




Primary Outcome Measures :
  1. positive predictive value [ Time Frame: 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.



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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02406274


Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: Maxine Jochelson, MD Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02406274     History of Changes
Other Study ID Numbers: 15-053
First Posted: April 2, 2015    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018

Keywords provided by Memorial Sloan Kettering Cancer Center:
Mammography
Contrast Enhanced Spectral Mammography
Palpable Breast Abnormalities
15-053

Additional relevant MeSH terms:
Congenital Abnormalities