NCT03929822

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 23, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 24, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 29, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2023

Completed
Last Updated

January 20, 2023

Status Verified

January 1, 2023

Enrollment Period

3.7 years

First QC Date

April 24, 2019

Last Update Submit

January 19, 2023

Conditions

Breast Screening

Keywords

MammographyContrast-Enhanced Spectral Mammography19-116

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy of CESM compared to mammography

    The radiologist will interpret the low energy images and record their findings.

    2 years

Study Arms (1)

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

Interventions

Contrast-Enhanced Spectral MammographyDIAGNOSTIC_TEST

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.

Contrast-Enhanced Spectral Mammography (CESM)

Eligibility Criteria

Age30 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen 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.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

Study Officials

  • Janice Sung, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2019

First Posted

April 29, 2019

Study Start

April 23, 2019

Primary Completion

January 19, 2023

Study Completion

January 19, 2023

Last Updated

January 20, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
SAP, ICF

Locations

US(1)