Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Can Contrast-Enhanced Spectral Mammography Improve the Accuracy of a Diagnosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03929822
Recruitment Status : Terminated (Lack of accrual)
First Posted : April 29, 2019
Last Update Posted : January 20, 2023
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to test whether contrast-enhanced spectral mammography (CESM) may be able to reduce the number of unnecessary biopsies in women whose screening mammograms had abnormal findings.

Condition or disease Intervention/treatment
Breast Screening Diagnostic Test: Contrast-Enhanced Spectral Mammography

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 32 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Contrast-Enhanced Spectral Mammography: Potential to Improve Diagnostic Accuracy
Actual Study Start Date : April 23, 2019
Actual Primary Completion Date : January 19, 2023
Actual Study Completion Date : January 19, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mammography

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Contrast-Enhanced Spectral Mammography (CESM)
Women called back from an abnormal screening mammogram/tomosynthesis exam will be offered CESM as part of their diagnostic work up. The radiologist will interpret the low energy images and record their findings.
 Diagnostic Test: Contrast-Enhanced Spectral Mammography
A standard dose of contrast material for other contrast mammography examinations and for body CT scanning, 1.5 ml/kg of Iohexol350 will be injected intravenously (IV) using a power injection (3-4 ml/s) with a maximum does of 150 ml. The IV injection is performed while the patient is in a sitting position. The mammogram will be performed in a standing position.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Diagnostic accuracy of CESM compared to mammography [ Time Frame: 2 years ]
    The radiologist will interpret the low energy images and record their findings.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women called back from a screening mammography by either FFDM or tomosynthesis with soft tissue abnormalities including masses, asymmetries, focal asymmetries or architectural distortion with or without calcifications.
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women called back from an abnormal screening mammogram/tomosynthesis exam will be offered CESM as part of their diagnostic work up.
Criteria

Inclusion Criteria:

  • Women called back from a screening mammography by either FFDM or tomosynthesis with soft tissue abnormalities including masses, asymmetries, focal asymmetries or architectural distortion with or without calcifications. Patients will be questioned regarding the possibility of pregnancy and will need a negative pregnancy test prior the study intervention.

Exclusion Criteria:

  • Age <30 years old
  • Screening mammography with only calcifications abnormalities
  • Male patients
  • Pregnant or lactating patients
  • Patients with any allergy to iodinated contrast
  • Patients with eGFR < 45
  • Patients that may be treated with radioactive iodine
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03929822


Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Janice Sung, MD Memorial Sloan Kettering Cancer Center
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03929822    
Other Study ID Numbers: 19-116
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: January 20, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Supporting Materials: Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Memorial Sloan Kettering Cancer Center:
Mammography
Contrast-Enhanced Spectral Mammography
19-116