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

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ClinicalTrials.gov Identifier: NCT03929822
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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 Phase
Breast Screening Diagnostic Test: Contrast-Enhanced Spectral Mammography Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 23, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mammography

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.




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.



Information from the National Library of Medicine

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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
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

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


Contacts
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Contact: Janice Sung, MD 646-888-5423 sungj@mskcc.org
Contact: Maxine Jochelson, MD 646-888-4507

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Janice Sung, MD    646-888-5423      
Contact: Maxine Jochelson, MD    646-888-4507      
Principal Investigator: Janice Sung, MD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Janice Sung, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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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: June 20, 2019
Last Verified: June 2019
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)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by Memorial Sloan Kettering Cancer Center:
Mammography
Contrast-Enhanced Spectral Mammography
19-116