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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

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

Clinicaltrials.gov identifier NCT03929822

Recruitment Status Recruiting

First Posted April 29, 2019

Last update posted February 5, 2020

Study Description

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:Breast Screening
  • Intervention/Treatment: Diagnostic Test: Contrast-Enhanced Spectral Mammography
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 250 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Diagnostic
  • Official Title: Contrast-Enhanced Spectral Mammography: Potential to Improve Diagnostic Accuracy
  • Actual Study Start Date: April 2019
  • Estimated Primary Completion Date: April 2021
  • Estimated Study Completion Date: April 2021
Arms and interventions
Arm Intervention/treatment
Experimental: 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
  • 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
  • Ages Eligible for Study: 30 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: No
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
Contacts

Contact: Janice Sung, MD 646-888-5423 sungj@mskcc.org

Contact: Maxine Jochelson, MD 646-888-4507

Locations

United States, New York
Memorial Sloan Kettering Cancer Center
New York

Sponsors and Collaborators

Memorial Sloan Kettering Cancer Center

Investigators

Principal Investigator: Janice Sung, MD Memorial Sloan Kettering Cancer Center

More Information
  • Responsible Party: Memorial Sloan Kettering Cancer Center
  • ClinicalTrials.gov Identifier: NCT03929822 History of Changes
  • Other Study ID Numbers: 19-116
  • First Posted: April 29, 2019 Key Record Dates
  • Last Update Posted: February 5, 2020
  • Last Verified: January 2020
  • 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)
  • 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