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

Breast Screening Clinical Trial

Official title:

Contrast-Enhanced Spectral Mammography: Potential to Improve Diagnostic Accuracy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03929822
• Other study ID #: 19-116
• Status: Terminated
• Start date: April 23, 2019
• Est. completion date: January 19, 2023

Study information

• Verified date: January 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: January 19, 2023
• Est. primary completion date: January 19, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Screening

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of CESM compared to mammography	The radiologist will interpret the low energy images and record their findings.	2 years

External Links

•   Memorial Sloan Kettering Cancer Center